Clinical trial NCT03871894: Indirect Calorimeter Based Study in Patients With Liver Cirrhosis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Liver Cirrhoses
Keywords: Indirect calorimeter
Resting energy expenditure
substrate utilization
nitrogen balance
Lead sponsor: Institute of Liver and Biliary Sciences, India
Sponsor class: OTHER
First posted: 2019-03-12
Enrollment: 83
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Part 1: An Observational study
timeFrame: One day (Observational)
measure: Part 2: A Randomized controlled trial
timeFrame: 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:
measure: Change in metabolic profile
timeFrame: The metabolic parameters would be assessed at the baseline, Day 7 and at Day 15 of enrollment
measure: Change in inflammatory milieu
timeFrame: The inflammatory markers would be assessed at the baseline, Day 7 and at Day 15 of enrollment
measure: Change in clinical parameters
timeFrame: 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.
measure: Change in ventilatory and arterial blood gas parameters
timeFrame: 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.
measure: Change in nutritional parameters
timeFrame: The nutritional parameters would be assesses at regular intervals maximum upto 28 days
measure: The association between energy metabolism, nutritional status and disease severity in patients with CLD
timeFrame: one day (Observational)
Other outcomes:
Locations:
city: New Delhi
country: India
facility: ILBS
state: Delhi
Study officials:
affiliation: Institute of Liver and Biliary Sciences, sector D-1, Vasantkunj, New Delhi
name: Jaya Benjamin, Msc,PhD
role: STUDY_DIRECTOR
References: