Metabolic and Clinical Effects of Enteral Nutrition Therapy: Measured Versus Estimated Energy and Substrate Requirements in Critically Ill Cirrhotics-A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 83
- 试验地点
- 2
- 主要终点
- Part 1: An Observational study
研究概览
简要总结
Part I- Observational study In the first part , investigator would investigate and compare the energy requirements and substrate utilization in healthy subjects and in patients with liver cirrhosis of various etiologies across the disease severity state viz compensated, stable decompensated, critically ill cirrhotics. The investigator would also enroll patients with chronic kidney disease, critically ill patients of acute liver failure or acute on chronic liver failure as disease controls.
Part II- Randomized Controlled Study All the eligible, critically ill cirrhotic patients on mechanical ventilator support would be randomized to a control group (receiving the nutritional therapy as per the standard enteral nutritional practice in a critical care setting) or the intervention group (receiving enteral nutrition based on proposed measured requirements by Indirect calorimetry (IC) given till the patient is in ICU(Intensive care unit). The IC would be done thrice a week in both groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Disease groups:
- •Patients with liver cirrhosis (diagnosis established based on routine clinical, biochemical and at least radiological, endoscopic or histological parameters.) admitted in Liver coma Intensive care unit and those admitted in ward.
- •Disease controls:
- •Patients with Acute liver failure (diagnosis established based on routine clinical, biochemical and at least radiological parameters) admitted in Liver coma Intensive care unit
- •Patients with severe acute pancreatitis (diagnosis established based on routine clinical, biochemical and at least radiological parameters) admitted in Liver coma Intensive care unit
- •Healthy Controls:
- •Healthy subjects- Relatives of patients with no known chronic diseases (Chronic obstructive pulmonary disease, Coronary artery disease, Type 2 diabetes, Hypertension, Hypothyroidism, Koch's disease) or not on any long term medications.
- •Patients with liver cirrhosis (diagnosis established based on routine clinical, biochemical and at least radiological, endoscopic or histological parameters.) admitted in Liver coma Intensive care unit who require mechanical ventilation
排除标准
- •Age<18 years
- •Active upper gastrointestinal bleeding
- •If there are conditions which precluded IC, such as an FiO2 >60 %, failure to cooperate, agitation, seizure activity, spasticity, or positive end-expiratory pressure (PEEP) >10 mmHg.
- •Pregnant women
- •Refused to consent/ inability to obtain informed consent.
- •Known long standing diabetic
- •If there is any evidence of medical/surgical instability
- •Hepatocellular carcinoma Extrahepatic malignancies
- •With persistent gastrointestinal dysfunction and ileus
- •Patients who would be readmitted to the ICU
- •Known long standing diabetic
- •Terminally ill patients on high inotropic support
- •Acute liver failure
- •If there is any evidence of medical/surgical instability
- •If patients are taking any portion of nutrition by mouth.
- •Pregnant women
- •Refused to consent/ inability to obtain informed consent.
- •Patient on CRRT- continuous renal replacement therapy
- •Severe co morbidities such as Chronic kidney disease requiring maintenance dialysis, COPD and Cardiac pathologies (Acute myocardial infarction, heart failure, ).
- •Hepatocellular carcinoma Extrahepatic malignancies
- •Moribund patient with likely survival <24 hours
- •Patients enrolled in other drug trials.
结局指标
主要结局
Part 1: An Observational study
时间窗: One day (Observational)
Study groups : 1. Healthy controls 2. Disease Groups * Patients with liver cirrhosis (compensated and decompensated) * Critically ill cirrhotics on mechanical ventilator support * patients with chronic kidney disease (CKD) (stable,non dialyzed, non oliguric outpatients) * Critically ill patients with Acute liver failure (ALF) on mechanical ventilator support * Critically ill patients with Acute on chronic liver failure(ACLF) on mechanical ventilator support * Severe acute pancreatitis on mechanical ventilator support Comparison of the prevalence of hyper and hypo metabolism in patients with chronic liver disease(CLD) and healthy controls and other disease groups.
Part 2: A Randomized controlled trial
时间窗: From date of enrollment until the date of ICU discharge /Leaving against medical advice, date of death from any cause, or off ventilatory support whichever comes first, assessed up to 28 days.
Study group:Critically ill Cirrhotic: Diagnosed cases of liver cirrhosis with 2 or more organ failures (liver + renal/circulatory or respiratory failures) requiring ICU admission and on mechanical ventilator support meeting inclusion and exclusion criteria The difference in the duration of mechanical ventilation in critically ill ventilated patients with liver cirrhosis when the nutritional therapy delivered as per estimated energy requirements versus measured requirements
次要结局
- Change in inflammatory milieu(The inflammatory markers would be assessed at the baseline, Day 7 and at Day 15 of enrollment)
- The association between energy metabolism, nutritional status and disease severity in patients with CLD(one day (Observational))
- Change in clinical parameters(The clinical parameters would be assessed daily from the date of enrollment until the date of ICU discharge, date of death from any cause, or out of mechanical ventilatory support whichever comes first, assessed up to 28 days.)
- Change in ventilatory and arterial blood gas parameters(The ventilatory and arterial blood gas parameters would be assessed daily from the date of enrollment until the date of ICU discharge, date of death from any cause, or out of mechanical ventilatory support whichever comes first, assessed up to 28 days.)
- Change in metabolic profile(The metabolic parameters would be assessed at the baseline, Day 7 and at Day 15 of enrollment)
- Change in nutritional parameters(The nutritional parameters would be assesses at regular intervals maximum upto 28 days)