NCT03871894

Indirect Calorimeter Based Study in Patients With Liver Cirrhosis

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 83 (actual)
• Sponsor: Institute of Liver and Biliary Sciences, India · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
OTHER	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
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

Timeline

• Start date: 2019-03-12
• Primary completion: 2022-08-31
• Completion: 2022-08-31
• First posted: 2019-03-12
• Last updated: 2022-10-24

Locations

1 site across 1 country: India