Home parenteral nutrition is a treatment enabling the patients with intestinal failure to live their lifes in their home environment. The possibility to commence and practise home parenteral nutrition requires not only a medical and pharmaceutical team, but also paramedical staff, which plays a signifiant part mainly in education of the patient and his close relatives. The study's aim was to characterize the patients involved in the home parenteral nutrition programme (HPN) and catheters used for this purpose and as well to analyze complication rate of the long term catheters related to their use and subsequent care. Into the retrospective quantitative study were included patiens treated with home parenteral nutrition since january 2009 to september 2015 within one nutrition care center. Data collection was realized by research in medical documentation. Altogether 135 patients were included in the study (93 female and 42 male), who have hade 227 catheters inserted in total (114 portcatheters, 73 Broviac catheters and 40 PICC) with 86 187 catheter days. The most frequent basic disease was cancer (36%) and the most prevalent indication to HPN was a short bowel syndrome (50%). Overall complication rate was 2,12/1000 catheter days (1,62 catheter sepsis, identically local infections and thrombotic...

A introdução da nutroterapia parenteral (NTP) contribuiu para redução da morbimortalidade de pacientes com contraindicação de uso do trato gastrointestinal. Porém, está relacionada a complicações clínicas, destacando-se a infecção associada ao uso de cateteres venosos centrais (CVCs) e a formação de biofilmes, que podem contribuir para piora clínica daqueles que necessita da NTP. O objetivo deste estudo foi avaliar a presença de biofilmes, a infecção sanguínea secundária ao uso de CVC utilizados em nutroterapia e os fatores de riscos associados ao processo infeccioso. Por meio de estudo clínico prospectivo, durante janeiro a junho de 2008, avaliou-se clinicamente por meio de registros médicos e de enfermagem todos pacientes em uso de parenteral internados no Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto, assim como os cateteres utilizados pelos mesmos, por meio de técnicas de cultura semiquantitativas e de hemoculturas. Aleatoriamente, algumas amostras dos CVCs utilizados foram enviadas para microscopia eletrônica de varredura e de alguns pacientes e de alguns profissionais da saúde foram coletados amostras se swab de pele. Foram avaliados 145 pacientes com idade média de 53±16 anos, destes 46% cursaram com infecção associada ao uso de CVC, ocorrendo óbito em 43% dos casos. A mortalidade foi associada ao maior risco de infecção (0.007),a complicações metabólicas como hiperglicemia (p <0.001) e distúrbio hidroeletrolítico (p=0.036) e à desnutrição (p=0.03). Com relação ao CVC, foram analisados um total de 179 CVCs, desses 49% estavam colonizados por micro-organismos e 34% foram relacionados à infecção sanguínea, não foram observadas diferenças clínicas quanto ao risco de colonização ou infecção sistêmica relacionada aos CVCs. Observou-se o risco de infecção cruzada em 21% do swabs auriculares coletados da equipe de saúde que assitia ao paciente. O risco da migração de micro-organismo da própria pele do paciente foi observado em 45% dos swabs coletados da mão e da região auricular do paciente. Quanto ao biofilme, foi observado a formação em 62% das amostras analisadas, sendo cocos mais comuns e Staphylococcus spp (39%) e Candida spp (19%) os micro-organismos mais frequentes. Conclui-se que a presença de biofilmes e infecção associada ao CVC utilizado para NTP é frequente e está relacionada ao aumento da mortalidade dos pacientes que necessitam desta nutroterapia / The introduction of parenteral nutrition therapy (PNT) has helped to reduce morbidity and mortality of patients with contraindications for use of the gastrointestinal tract. However, is related to clinical complications, especially infection associated with the use of central venous catheters (CVCs) and the formation of biofilms, which may contribute to clinical worsening of those who need the PNT. The aim of this study was to evaluate the presence of biofilms, the risk of infection related to the use of CVC used in parenteral nutrition, as well as risk factors associated with infection. Through a prospective study during January to June 2008 were evaluated clinically by means of medical records and nursing all patients who needed parenteral nutrition support at Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto, as well as catheters used by them, by means of semiquantitative culture techniques and blood cultures. Randomly, some samples of CVCs used were sent for scanning electron microscopy. Also, some samples of skin´s swabs were collected from, some patients and some health professionals. We evaluated 145 patients with mean age 53 ± 16 years, 46% of those presenting with infection associated with the use of CVC, death occurring in 43% of cases. Mortality was associated with increased risk of infection (0.007), hyperglycemia (p <0.001), electrolyte disturbance (p = 0.036) and malnutrition (p = 0.03). Regarding the CVC were analyzed a total of 179 CVCs, 49% of these were colonized by micro-organisms and 34% were related to bloodstream infection, there were no clinical differences between the risk of colonization or bloodstream infection related to CVCs. It was noted the risk of cross infection in 21% of ear swabs collected from the health team whom attended to the patient. The risk of migration of micro-organism of the patient\'s own skin was observed in 45% of the swabs collected from the hand and around patient´s ear. Biofilm formation was observed in 62% of samples, being more common cocci. Staphylococcus spp (39%) and Candida spp (19%) were the most frequent micro-organisms. The presence of biofilms and infection related to CVC used for NTP is frequent and is associated with increased mortality of patients who need this nutritional support.

A terapia nutricional mostra-se de grande importância no tratamento do doente crítico, por apresentar impacto favorável em seu desfecho clínico. No entanto, até 70% dos pacientes em unidade de terapia intensiva podem não receber terapia nutricional adequada. Isso ocorre, em parte, pela falta de formação e de conhecimento dos profissionais de saúde sobre princípios de nutrição clínica. O objetivo do presente estudo foi avaliar o impacto da introdução de um programa de educação médica em terapia nutricional em uma unidade de terapia intensiva sobre a qualidade da terapia nutricional e os resultados clínicos de seus pacientes. O presente estudo foi desenvolvido em três fases distintas: 1) Pré-programa educacional (PP): 50 pacientes recém-admitidos em unidade de terapia intensiva foram selecionados consecutivamente para avaliação da qualidade da terapia nutricional a eles oferecida e seus desfechos clínicos, através de visitas periódicas. 2) Programa Educacional (PE): foram criados protocolos nutricionais específicos. Um programa de educação em terapia nutricional baseado nesses protocolos (palestras, workshops e discussões à beira leito) foi introduzido nessa unidade de terapia intensiva. 3) Pós-programa educacional (PO): a qualidade da terapia nutricional e os desfechos clínicos de um segundo grupo de 50 pacientes foram avaliados, utilizando-se a mesma metodologia da fase 1 (PP). Os marcadores utilizados para avaliação da qualidade da terapia nutricional foram: avaliação nutricional, adequação da oferta de energia, tempo de jejum e introdução de nutrição enteral precoce. Tempo de permanência na unidade de terapia intensiva e tempo de internação hospitalar foram registrados e avaliados como desfechos clínicos principais. Os pacientes da fase PP e PO não diferiram em idade, APACHEII, sexo, tipo de diagnóstico na admissão e avaliação nutricional. Observou-se redução no tempo de jejum (PP 3,8 dias ± 3,1 vs PO: 2,2 dias ± 2,6; p = 0,002), melhora na adequação calórica (PP 74,2% ± 33,3 vs PO 96,2 ± 23,8%; p <0,001) e aumento da indicação de nutrição enteral precoce (PP 24% vs PO 60%; p = 0,001) nos pacientes da fase PO, em comparação com os pacientes da fase PP. Além disso, o tempo de permanência na unidade de terapia intensiva foi menor (PP: 21,9 dias ± 15,2 vs PO: 12,2 dias ± 8,0; p <0,001) nos pacientes da fase PO, em comparação com os pacientes da fase PP. Não houve alteração significativa no tempo de internação hospitalar. A introdução de um modelo de educação em terapia nutricional em uma unidade de terapia intensiva melhorou a qualidade da terapia nutricional e diminuiu o tempo de permanência de seus pacientes / In critically ill patients, nutritional therapy favorably impacts clinical outcomes. However, up to 70% of patients in the intensive care unit do not receive adequate nutritional therapy, due, partially, to the lack of training and knowledge regarding nutrition principles among healthcare providers. The aim of this study was to evaluate the impact of a medical educational program in an intensive care unit on the quality of the nutritional therapy and clinical outcomes. The study protocol was developed among three distinct phases: 1) Pre-educational program (Pre-EP): 50 patients newly admitted to the intensive care unit were consecutively selected to assess their regular performed nutritional therapy and clinical end-points. 2) Educational program (EP): specific nutritional protocols were created and an education program (lectures, workshops and bedside discussions) were implemented. 3) Post educational program (Post-EP): a second group of 50 patients was enrolled and observed using the same phase 1 (Pre-EP) methodology. Nutritional therapy practice was evaluated through the application of specific quality indicators and the evaluation of nutritional therapy-related complications, considering as main markers the nutritional assessment, adequacy of energy requirement, duration of fasting and use of early enteral nutrition. Intensive care unit length of stay and hospital length of stay were recorded and measured as primary end-points. The Pre-EP and Post-EP patients did not differ in age, APACHEII, gender, admission diagnosis (surgery x medical) and nutritional assessment. Duration of fasting decreased (Pre-EP 3.8 days ±3.1 vs. Post-EP: 2.2 days ±2.6; p=0.002), the adequacy of nutritional therapy improved (Pre-EP 74.2% ±33.3 vs. Post-EP 96.2%±23.8; p<0.001) and enteral nutrition was earlier initiated (Pre-EP 24% vs. Post-E 60%; p=0.001). Intensive care unit length of stay also decreased (Pre-EP: 21.9 days±15.2 vs Post-EP: 12.2 days ±8.0; p<0.001). No changes were observed in hospital length of stay. Conclusion: Implementing a medical nutrition educational model in an intensive care unit improved the quality of nutritional therapy and decreased the length of stay of their patients

Moléculas HLA-DR e co-estimulatórias tem papel central na função imune de leucócitos. Diferentes emulsões lipídicas (EL) podem alterar funções imunes de leucócitos. Para avaliar os efeitos de diferentes EL sobre a expressão de moléculas HLA-DR, CD80 e CD86 presentes na superfície de monócitos/macrófagos (MO/M?) e CD28 e CD152 presentes na superfície de linfócitos T auxiliares (L? CD4) humanos, células mononucleares do sangue periférico de voluntários saudáveis (n=10) foram separadas com uso de Ficoll Hypaque (d=1,007) e incubadas por 48 horas (MO/M?) e 72 horas (L?) em meio RPMI 1640 acrescidas ou não (controle negativo) de diferentes EL comerciais ou misturas experimentais na concentração de 1mg/mL. De acordo com o tipo da emulsão lipídica adicionada ao meio de cultura, as células foram divididas em seis grupos experimentais: a) Controle negativo - células mononucleares cultivadas sem o acréscimo de EL b) TCLn-6 - células mononucleares cultivadas com EL a base de óleo de soja rica em ácidos graxos poliinsaturados tipo n-6 (AGPI n-6), c) TCLn-6/TCLn-3 - células mononucleares cultivadas com mistura experimental contendo 80% da EL a base de óleo de soja e 20% de EL a base de óleo de peixe rica em AGPI tipo n-3, d) TCM/TCLn6 - células mononucleares cultivadas com EL composta por 50% óleo de coco, rico em triglicérides de cadeia média e 50% de óleo de soja, e) TCM/TCLn-3 - células mononucleares cultivadas com mistura experimental contendo 80% de EL composta por 50% óleo de coco e 50% de óleo de soja e 20% de EL a base de óleo de peixe, f) SMOF - células mononucleares cultivadas com a nova EL contendo 30% de óleo de soja, 30% de triglicérides de cadeia média, 25% de óleo de oliva e 15% de óleo de peixe. As células mononucleares foram ativadas pelo uso de 10?g/mL de fitohemaglutinina. A expressão das moléculas de superfície foi analisada por citometria de fluxo. A porcentagem de fluorescência, que indica o número de células expressando as moléculas em estudo e a intensidade de fluorescência, que indica de forma indireta o número de moléculas expressas por células, foram medidas. Os resultados obtidos foram submetidos à teste estatístico Friedman e pós-teste Student-Newman-Keuls, adotando-se nível de significância de p<0,05. Devido às diferenças na expressão basal dos doadores, os resultados de intensidade de fluorescência foram transformados em porcentagem relativa ao controle basal (Basal=100). Nos grupos TCLn-6, TCLn-6/TCLn-3, TCM/TCLn-6, TCM/TCLn-3 e SMOF, a intensidade de fluorescência de moléculas HLA-DR expressas na superfície de monócitos/macrófagos diminuiu (medianas = 87,6; 84,0; 81,0; 85,0 e 80,0 respectivamente) em relação ao controle negativo (CN) (mediana=100,0) p=0,01. Todos os grupos tratados com EL aumentaram o número de linfócitos T auxiliares expressando moléculas CD28 (medianas = 90,9; 90,4; 91,5; 92,6 e 90,1 respectivamente) em relação ao CN (mediana=82,8) p=0,001 e também o número de moléculas CD152 expressas por células na superfície de linfócitos T auxiliares (medianas = 120,6; 108,8; 127,7; 114,6 e 121,3 respectivamente) em relação ao CN (mediana=100,0), p=0,03. Não foram encontradas diferenças estatísticas na expressão de moléculas CD80 e CD86 na superfície de monócitos/macrófagos cultivados com diferentes EL. Ainda não foram encontradas diferenças no número de linfócitos T auxiliares expressando CD152. Finalmente a expressão por células de moléculas CD28 na superfície de linfócitos T auxiliares também não mostrou alteração significante com as diferentes emulsões lipídicas. Conclusão: Emulsões lipídicas parenterais in vitro, diminuem a expressão de moléculas HLA-DR na superfície de monócitos/macrófagos e aumentam a expressão de moléculas CD28 e CD152 na superfície de linfócitos T auxiliares humanos. Estas alterações podem ser um dos mecanismos pelos quais as EL modulam funções de células imunes / HLA-DR and co-stimulatory molecules play a central role on leucocytes immune function. Different lipid emulsions (LE) may change leucocytes immune function. It is of interest to study the effect of different LE on HLA-DR and costimulatory molecules expression. To access the effect of LE on the HLA-DR, CD80 and CD86 expression on monocytes/macrophages (MO/MØ) surface and CD28 and CD152 (CD80/CD86 co-stimulatory molecules receptor) expression on human T helper lymphocytes (LØ CD4) surface we obtained mononuclear cells from peripheral blood of healthy volunteers (n=10) by using ficoll hypaque (d=1.077). The cells were cultured for 48 hours (MOMØ) and 72 hours (LØ CD4) and incubated with RPMI 1640 medium without (negative control) or added with 1mg/mL of commercial or experimental mixtures of five LE. Groups: a) NC - negative control without LE, b) LCTn-6 - n-6 polyunsaturated fatty acids (PUFA) rich LE ( soybean oil), c) LCTFO - 80% of LCT and 20% of n-3 PUFA rich LE (FO) (fish oil), d) MCT/LCT - LE containing 50% of medium chain triglycerides and 50% of n-6 PUFA rich LE, e) MCT/LCTFO - 80% of MCT/LCT LE and 20% of FO LE and f) SMOF - a new LE containing 30% of soybean oil, 30% of medium chain triglycerides, 25% of olive oil and 15% of fish oil. Mononuclear cells were activated by using 10?g/mL of phytohemagglutinin. Surface molecules expression was measured by flow cytometry. Percentage and intensity of fluorescence were recorded and the data were submitted to Friedman statistical test and Student-Newman-Keuls post test (p<0,05). Due the differences in basal expression between donors, prior to statistical tests, data from intensity of fluorescence were transformed of percentage relative of basal expression (where basal=100). All LE groups LCT, LCTFO, MCT/LCT, MCT/LCTFO and SMOF decreased HLA-DR intensity of fluorescence on monocytes/macrophages (mean= 87.6, 84.0, 81.0, 85.0, and 80.0 respectively) in relation to negative control (NC) (mean=100.0) cultured without LE (p=0,01). All LE groups increased the percentage of lymphocytes expressing CD28 (means=90.9, 90.4, 91.5, 92.6 and 90.1 respectively) in relation to control (mean=82.8) p=0,001 and CD152 intensity of fluorescence on lymphocytes cultured with all different LE (mean=120,6; 108,8; 127,7; 114,6 and 121,3 respectively) in relation to NC (mean=100,0), p=0,03. No significant differences were found on CD80 and CD86 expression on monocytes/macrophages surface, CD28 intensity of fluorescence and the percentage of lymphocytes expressing CD152 on lymphocytes cultured with the different studied LE. Conclusion: In vitro parenteral LE decreased HLA-DR expression on human monocytes/macrophages surface and increase co-stimulatory molecules receptor expression on human lymphocytes surface. These changes could be one of the mechanisms of LE modulation of immune cells functions

Objetivos: O objetivo do estudo foi avaliar comparativamente a incidência de complicações pós-operatórias em pacientes cirúrgicos submetidos a diferentes estratégias de nutrição parenteral: Precoce vs. Tardia. Desenho: Estudo fase IV de superioridade, unicêntrico, prospectivo e randomizado. Local: Instituto do Câncer do Estado de São Paulo, Faculdade de Medicina da Universidade de São Paulo, Brasil. Participantes: Adultos, com idade maior ou igual a dezoito anos, portadores de neoplasia gastrointestinal (esôfago, estômago e/ou intestino), metastática ou não, submetidos à cirurgia oncológica eletiva não paliativa. Intervenção: Os pacientes foram randomizados em dois grupos para nutrição parenteral precoce ou tardia. No grupo Precoce, a nutrição parenteral total era iniciada no segundo dia de pós-operatório e, no grupo Tardio, os pacientes recebiam nutrição parenteral a partir do 7º dia de pós-operatório. Os pacientes e os analisadores de desfechos desconheciam o grupo de tratamento. A análise foi feita de acordo com intenção de tratar. Desfecho primário: Desfecho composto de complicações pós-operatórias em 30 dias incluindo complicações respiratórias, cardiovasculares, renais, neurológicas, infecciosas e cirúrgicas. Desfechos secundários: Os desfechos secundários foram mortalidade em 30 dias, necessidade de unidade de terapia intensiva, tempo total de internação na unidade de terapia intensiva e no hospital, readmissão na unidade de terapia intensiva, tempo de ventilação mecânica, tempo de uso de vasopressores, disfunção hepática e reinternação hospitalar. Resultados: No período de 08 de maio de 2013 a 07 de outubro de 2017, foram analisados para elegibilidade 658 pacientes, tendo sido randomizados 167 para o grupo nutrição parenteral Precoce e 168 pacientes para o grupo nutrição parenteral Tardia. Em 30 dias, o grupo Precoce apresentou 46 complicações (27,5%) e o grupo Tardio apresentou 68 complicações (40,5%) [Intervalo de confiança 95% da diferença entre os grupos - 12,9 (-22,7 a -2,8), p=0,013]. Em relação aos desfechos secundários, não houve diferenças entre os grupos. Conclusão: Em pacientes com câncer submetidos à cirurgia gastrointestinal eletiva, a estratégia nutricional parenteral Precoce foi superior à nutricional parenteral Tardia na prevenção de complicações pós-operatórias. Registro: www.clinicaltrials.gov: NCT0183 9617 / Objectives: The objective of this study was to compare the incidence of postoperative complications in surgical patients submitted to different parenteral nutrition strategies: Early vs. Late. Design: Phase IV study of superiority, unicentric, prospective and randomized. Location: Cancer Institute of the State of São Paulo, Faculty of Medicine, University of São Paulo, Brazil. Participants: Adults, age equal or higher than eighteen years, gastrointestinal neoplasia (esophagus, stomach and / or intestine), metastatic or not, submitted to non-palliative elective oncologic surgery. Intervention: Patients were randomized into two groups: Early parenteral nutrition or Late parenteral nutrition. In the Early group, total parenteral nutrition was started on the second postoperative day, and in the Late group, patients received parenteral nutrition on the 7th postoperative day. Patients and outcome assessors were blinded to the treatment group. The analysis was performed according to intent to treat. Primary outcome: A composite endpoint of postoperative complications in 30 days including respiratory, cardiovascular, renal, neurological, infectious and surgical complications. Secondary outcomes: Secondary outcomes were 30-day mortality, need for intensive care unit, total length of hospital and intensive care unit stay, intensive care unit readmission, duration of mechanical ventilation, duration of vasopressors, hepatic dysfunction and hospital readmission. Results: Between May 8, 2013 and October 7, 2017, 658 patients were assessed for eligibility, and 167 were randomized to the Early group and 168 patients to the Late group. At 30 days, the Early group had 46 complications (27.5%) and the Late group had 68 complications (40.5%) - [absolute difference, 95% Confidence Interval of the absolute difference -12.9 (-22.7 to -2.8), p = 0.013]. The secondary outcomes were not different between the groups. Conclusion: In patients with cancer undergoing elective gastrointestinal surgery, Early parenteral nutritional strategy was superior than the Late strategy in avoiding postoperative complications. Registration: www.clinicaltrials.gov: NCT01839617

(EN) Home parenteral nutrition (DPV) has become a routine part of patients care whose oral intake is reduced or completely eliminated. An integral part of the application of DPV is also the permanent or temporary need for functioning vascular access. Catheter complications negatively affect the quality of life, morbidity and in case of catheter sepsis the patient mortality. In addition it also brings increased costs for therapy and the need for patients re-hospitalization. The main objective of our study is to analyze catheter-related complications and to determine whether use of catheter plugs like TauroLock and TauroLock Hep and Tegaderm CHG antimicrobial dressing affect the incidence of catheter complications with DPV, and whether the incidence of complications is affected by a person who treated the catheter. The secondary objective is to characterize patients with served DPV and types of catheter used for this purpose.The method chosen is a retrospective observational cohort study. The study contains 52 patients with 72 catheters (39 Broviac, 18 PICC and 15 ports). The monitored number of catheter- days in total was 33,875. We conclude that the use TauroLock Hep is effective in the prevention of catheter complications and significantly reduces the overall incidence of all complications (p =...

Objective: The objective of this thesis was to facilitate clinical trials of the optimal lipid based approach (e.g.: omega-3 containing lipid emulsions or minimization of conventional lipid) for the prevention of Intestinal Failure Associated Liver Disease (IFALD). This was achieved through 3 related projects. Project 1: The first project examined the risk of advanced IFALD associated with exposure to conventional intravenous lipid in a logistic regression model. The study demonstrated that each day of conventional lipid (> 2.5 g/kg/day) was associated with a significant increase in the risk of advanced IFALD [Odds Ratio: 1.04 95% CI: 1.003 – 1.06]. Project 2: The second project surveyed experts in Intestinal Failure regarding their beliefs of the efficacy of lipid minimization and lipid emulsions containing omega-3 fatty acids relative to conventional emulsions. The goal of the project was to develop prior distributions of the treatment response for these therapies that can be used in Bayesian analyses of clinical trials. Our results demonstrated consistent expert opinion that the novel lipid based approaches are superior to conventional therapy. Estimates of the treatment effect were similar for the two approaches (median elicited treatment response, relative to conventional lipid, was a relative risk of 0.53 for omega-3 lipid and 0.45 for lipid minimization). Project 3: The final project was a pilot randomized controlled trial of an omega-3 emulsion. The study demonstrated that the randomized design is a feasible strategy for evaluating lipid based approaches for the prevention of IFALD. A Bayesian preliminary assessment of the results of the trial, suggests a high likelihood that the trial will demonstrate a difference between the conventional and omega-3 emulsion evaluated in the trial. However, since the analysis was blinded, the direction of the difference is not known. Conclusion: This thesis will contribute to the design and analysis of high quality and feasible randomized trials that will allow investigators to address the optimal lipid based approach to the management of IFALD.

L'exposition à la lumière des solutions de nutrition parentérale (NP) génère des peroxydes tels que l'H2O2 et l'ascorbylperoxyde (AscOOH). Cette absence de photo-protection provoque une augmentation des triglycérides (TG) plasmatique chez les enfants prématurés et chez un modèle animal, ayant un stress oxydatif et une stéatose hépatique indépendante de l’exposition au H2O2. Nous pensons que l'AscOOH est l'agent actif conduisant à l'élévation des TG. Le but est d'investiguer le rôle de l'AscOOH sur les métabolismes du glucose et des lipides à l'aide d'un modèle animal néonatal de NP. / The light exposure of parenteral nutritive solutions generates peroxides such as H2O2 and ascorbylperoxide. This absence of photo-protection is associated with higher plasma triacylglycerol concentration (TG) in premature infants and, in animals, with oxidative stress and a H2O2 independent hepatic steatosis. We hypothesized that ascorbylperoxide is the active agent leading to high TG. The aim was to investigate the role of ascorbylperoxide on glucose and lipid metabolism in an animal model of neonatal parenteral nutrition.

Objective: The objective of this thesis was to facilitate clinical trials of the optimal lipid based approach (e.g.: omega-3 containing lipid emulsions or minimization of conventional lipid) for the prevention of Intestinal Failure Associated Liver Disease (IFALD). This was achieved through 3 related projects. Project 1: The first project examined the risk of advanced IFALD associated with exposure to conventional intravenous lipid in a logistic regression model. The study demonstrated that each day of conventional lipid (> 2.5 g/kg/day) was associated with a significant increase in the risk of advanced IFALD [Odds Ratio: 1.04 95% CI: 1.003 – 1.06]. Project 2: The second project surveyed experts in Intestinal Failure regarding their beliefs of the efficacy of lipid minimization and lipid emulsions containing omega-3 fatty acids relative to conventional emulsions. The goal of the project was to develop prior distributions of the treatment response for these therapies that can be used in Bayesian analyses of clinical trials. Our results demonstrated consistent expert opinion that the novel lipid based approaches are superior to conventional therapy. Estimates of the treatment effect were similar for the two approaches (median elicited treatment response, relative to conventional lipid, was a relative risk of 0.53 for omega-3 lipid and 0.45 for lipid minimization). Project 3: The final project was a pilot randomized controlled trial of an omega-3 emulsion. The study demonstrated that the randomized design is a feasible strategy for evaluating lipid based approaches for the prevention of IFALD. A Bayesian preliminary assessment of the results of the trial, suggests a high likelihood that the trial will demonstrate a difference between the conventional and omega-3 emulsion evaluated in the trial. However, since the analysis was blinded, the direction of the difference is not known. Conclusion: This thesis will contribute to the design and analysis of high quality and feasible randomized trials that will allow investigators to address the optimal lipid based approach to the management of IFALD.

Diss. (sammanfattning) Stockholm : Karolinska institutet, 2005. / Härtill 4 uppsatser.