Indirect Calorimeter Based Study in Patients With Liver Cirrhosis

NCT ID: NCT03871894

Last Updated: 2022-10-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 83 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-12
• Study Completion Date: 2022-08-31

Brief Summary

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.

Conditions

Liver Cirrhoses

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Control arm

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.

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: OTHER

Nutrition therapy based on measured energy expenditure by indirect calorimetry (IC) done alternate day till patient on ventilatory support and protein intake 1.5 g/kg IBW/day

Standard and fixed nutritional intervention till patient in ICU

Intervention Type: OTHER

Fixed standard nutritional therapy 35-40 Kcal/Kg IBW/day and 1.5 g protein /Kg IBW/Day till patient on ventilator

Intervention arm

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.

Group Type: EXPERIMENTAL

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

Intervention Type: OTHER

Nutrition therapy based on measured energy expenditure by indirect calorimetry (IC) done alternate day till patient on ventilatory support and protein intake 1.5 g/kg IBW/day

Standard and fixed nutritional intervention till patient in ICU

Intervention Type: OTHER

Fixed standard nutritional therapy 35-40 Kcal/Kg IBW/day and 1.5 g protein /Kg IBW/Day till patient on ventilator

Interventions

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

Nutrition therapy based on measured energy expenditure by indirect calorimetry (IC) done alternate day till patient on ventilatory support and protein intake 1.5 g/kg IBW/day

Intervention Type: OTHER

Standard and fixed nutritional intervention till patient in ICU

Fixed standard nutritional therapy 35-40 Kcal/Kg IBW/day and 1.5 g protein /Kg IBW/Day till patient on ventilator

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Institute of Liver and Biliary Sciences, India

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jaya Benjamin, Msc,PhD

Role: STUDY_DIRECTOR

Institute of Liver and Biliary Sciences, sector D-1, Vasantkunj, New Delhi

Locations

ILBS

New Delhi, National Capital Territory of Delhi, India

Countries

India

Other Identifiers

ILBS-METALIC01

Identifier Type: -

Identifier Source: org_study_id