Indirect Calorimeter Based Study in Patients With Liver Cirrhosis

NCT03871894 | Completed

• 1 other identifier: ILBS-METALIC01
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 1

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

Keywords

Indirect calorimeter; Resting energy expenditure; substrate utilization; nitrogen balance

Outcome Measures

Primary Outcomes (2)

• Part 1: An Observational study

  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.

  One day (Observational)

• Part 2: A Randomized controlled trial

  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

  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.

Secondary Outcomes (6)

• Change in metabolic profile

  The metabolic parameters would be assessed at the baseline, Day 7 and at Day 15 of enrollment

• Change in inflammatory milieu

  The inflammatory markers would be assessed at the baseline, Day 7 and at Day 15 of enrollment

• 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 nutritional parameters

  The nutritional parameters would be assesses at regular intervals maximum upto 28 days

Study Arms (2)

Control arm

ACTIVE COMPARATOR

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.

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

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.

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

Interventions

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

Control arm; Intervention arm

Standard and fixed nutritional intervention till patient in ICU OTHER

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

Control arm; Intervention arm

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institute of Liver and Biliary Sciences, India: lead

Study Sites (1)

ILBS

New Delhi, National Capital Territory of Delhi, 110070, India

Location

MeSH Terms

Interventions

Intensive Care Units

Intervention Hierarchy (Ancestors)

Hospital Units; Health Facilities; Health Care Facilities Workforce and Services

Study Officials

• Jaya Benjamin, Msc,PhD

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2019
• First Posted: March 12, 2019
• Study Start: March 12, 2019
• Primary Completion: August 31, 2022
• Study Completion: August 31, 2022
• Last Updated: October 24, 2022

Record last verified: 2022-09

Locations

IN (1)