ICLC: Indirect Calorimeter Based Study in Patients With Liver Cirrhosis

Sponsor

Institute of Liver and Biliary Sciences, India (Other)

Overall Status

Unknown status

CT.gov ID

NCT03871894

Collaborator

(none)

Enrollment

Location

Arms

32.1

Anticipated Duration (Months)

1.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Liver Cirrhoses	Other: Indirect calorimetry based nutritional intervention till patient in ICU(Intensive care unit) Other: Standard and fixed nutritional intervention till patient in ICU	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

Metabolic and Clinical Effects of Enteral Nutrition Therapy: Measured Versus Estimated Energy and Substrate Requirements in Critically Ill Cirrhotics-A Randomized Controlled Trial

Anticipated Study Start Date :

May 1, 2019

Anticipated Primary Completion Date :

Jan 1, 2021

Anticipated Study Completion Date :

Jan 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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; 1.5-2g protein per kg per day.	Other: Standard and fixed nutritional intervention till patient in ICU Fixed standard nutritional therapy 40 Kcal/Kg IBW/day and 1.5 to 2 g protein /Kg IBW/Day throughout the period of ICU stay
Experimental: 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)	Other: Indirect calorimetry based nutritional intervention till patient in ICU(Intensive care unit) Nutrition therapy based on indirect calorimetry (IC) measurements(measured resting energy expenditure and/or substrate utilization) and to be adjusted according to the variations shown by IC.

Arm

Intervention/Treatment

Active Comparator: 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; 1.5-2g protein per kg per day.

Other: Standard and fixed nutritional intervention till patient in ICU

Fixed standard nutritional therapy 40 Kcal/Kg IBW/day and 1.5 to 2 g protein /Kg IBW/Day throughout the period of ICU stay

Experimental: 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)

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

Nutrition therapy based on indirect calorimetry (IC) measurements(measured resting energy expenditure and/or substrate utilization) and to be adjusted according to the variations shown by IC.

Outcome Measures

Primary Outcome Measures

To study and compare the resting energy expenditure(REE) measured by Indirect Calorimetry between all the groups [1 day]
To study and compare the substrate utilization(Respiratory quotient- RQ) at fasting state measured by Indirect Calorimetry between all the groups. [1 day]
The effect of nutritional therapy as per standard versus measured protocol during ICU stay on duration of mechanical ventilation in critically ill ventilated patients with cirrhosis [28 days]
The effect of nutritional therapy as per standard versus measured protocol during ICU (Intensive Care Unit) stay on mortality in critically ill ventilated patients with cirrhosis [28 days]

Secondary Outcome Measures

The effect of nutritional therapy as per standard versus measured protocol during ICU stay on the changes non esterified fatty acid levels (NEFA) in critically ill ventilated patients with cirrhosis [28 days]
The effect of nutritional therapy as per standard versus measured protocol during ICU stay on the levels of interleukin 6 (IL6) in critically ill ventilated patients with cirrhosis [28 days]
The effect of nutritional therapy as per standard versus measured protocol during ICU stay on the Fraction of Inspired oxygen (FiO2) in critically ill ventilated patients with cirrhosis [28 days]
The effect of nutritional therapy as per standard versus measured protocol during ICU stay on the incidence of new onset infection in critically ill ventilated patients with cirrhosis [28 days]
The effect of nutritional therapy as per standard versus measured protocol during ICU stay on NUTRIC (The Nutrition Risk in Critically ill score) score range (0-9 ) in critically ill ventilated patients with cirrhosis. [28 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.