Indirect Calorimeter Based Study in Patients With Liver Cirrhosis (METALIC)

Institute of Liver and Biliary Sciences, India

Status: Completed

Conditions: Liver Cirrhoses

Treatments: Other: Standard and fixed nutritional intervention till patient in ICU; Other: Indirect calorimetry based nutritional intervention till patient in ICU(Intensive care unit)

Study type: Interventional

Funder types: Other

Identifiers

NCT03871894

ILBS-METALIC01

Details and patient eligibility

About

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.

Enrollment: 83 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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83 participants in 2 patient groups

Control arm

Active Comparator group

Description:

This is the group of critically ill cirrhotic patients on mechanical ventilator support who would receive the nutritional therapy as per the standard enteral nutritional practice in a critical care setting in cirrhotics till the period admitted in ICU(Intensive care unit) 35-40 Kcal/Kg IBW/day; 1.5g protein per kg per day.

Treatment:

Other: Indirect calorimetry based nutritional intervention till patient in ICU(Intensive care unit)

Other: Standard and fixed nutritional intervention till patient in ICU

Intervention arm

Experimental group

Description:

This is the group of critically ill cirrhotic patients on mechanical ventilator support who would receive the nutritional therapy based on indirect calorimetry measurements till the period admitted in ICU(Intensive care unit); 1.5g protein per kg per day.

Treatment:

Other: Indirect calorimetry based nutritional intervention till patient in ICU(Intensive care unit)

Other: Standard and fixed nutritional intervention till patient in ICU