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

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ClinicalTrials.gov Identifier: NCT03871894
Recruitment Status : Unknown
Verified January 2019 by Institute of Liver and Biliary Sciences, India.
Recruitment status was:  Recruiting
First Posted : March 12, 2019
Last Update Posted : March 12, 2019
Sponsor:
Information provided by (Responsible Party):
Institute of Liver and Biliary Sciences, India

Study Description
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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 Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : May 1, 2019
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : January 2022

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Arms and Interventions
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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
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Primary Outcome Measures :
  1. To study and compare the resting energy expenditure(REE) measured by Indirect Calorimetry between all the groups [ Time Frame: 1 day ]
  2. To study and compare the substrate utilization(Respiratory quotient- RQ) at fasting state measured by Indirect Calorimetry between all the groups. [ Time Frame: 1 day ]
  3. 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 [ Time Frame: 28 days ]
  4. 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 [ Time Frame: 28 days ]

Secondary Outcome Measures :
  1. 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 [ Time Frame: 28 days ]
  2. 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 [ Time Frame: 28 days ]
  3. 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 [ Time Frame: 28 days ]
  4. 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 [ Time Frame: 28 days ]
  5. 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. [ Time Frame: 28 days ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03871894


Contacts
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Contact: Jaya Joy Benjamin, Msc,PhD 011-46300000 jayabenjaminilbs@gmail.com

Locations
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India
ILBS Recruiting
New Delhi, Delhi, India, 110070
Contact: Varsha Shasthry, MBBS,PDCC    011-46300000    varsha.bhat@gmail.com   
Sponsors and Collaborators
Institute of Liver and Biliary Sciences, India
More Information
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Responsible Party: Institute of Liver and Biliary Sciences, India
ClinicalTrials.gov Identifier: NCT03871894    
Other Study ID Numbers: ILBS-ICLC01
First Posted: March 12, 2019    Key Record Dates
Last Update Posted: March 12, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Institute of Liver and Biliary Sciences, India:
Indirect calorimeter
Resting energy expenditure
substrate utilization
nitrogen balance
Additional relevant MeSH terms:
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Liver Cirrhosis
Fibrosis
Pathologic Processes
Liver Diseases
Digestive System Diseases