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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: An Observational study | Study groups :
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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in metabolic profile | The effect of nutritional therapy as per estimated energy requirements versus measured requirements in critically ill ventilated patients with liver cirrhosis on the Insulin resistance, ketone bodies, Non-esterified fatty acids (NEFA), amino acids profile and blood sugar levels would be studied | The metabolic parameters would be assessed at the baseline, Day 7 and at Day 15 of enrollment |
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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:
Healthy Controls:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jaya Benjamin, Msc,PhD | Institute of Liver and Biliary Sciences, sector D-1, Vasantkunj, New Delhi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ILBS | New Delhi | National Capital Territory of Delhi | 110070 | India |
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| ID | Term |
|---|---|
| D007362 | Intensive Care Units |
| ID | Term |
|---|---|
| D006757 | Hospital Units |
| D006268 | Health Facilities |
| D005159 | Health Care Facilities Workforce and Services |
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| 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 |
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| Change in inflammatory milieu | The effect of nutritional therapy as per estimated energy requirements versus measured requirements in critically ill ventilated patients with liver cirrhosis on the levels of interleukin 6 (IL-6), Tumor necrosis factor(TNF alfa), CRP(C reactive protein)would be studied | The inflammatory markers would be assessed at the baseline, Day 7 and at Day 15 of enrollment |
| Change in clinical parameters | The effect of nutritional therapy as per estimated energy requirements versus measured requirements in critically ill ventilated patients with liver cirrhosis ondevelopment of new onset infection, resolution of sepsis, renal function and length of stay in the ICU/hospital would be studied | 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 effect of nutritional therapy as per estimated energy requirements versus measured requirements in critically ill ventilated patients with liver cirrhosis on ventilator parameters (FiO2, PEEP, PF ratio) and arterial blood gas parameters( PO2, PCO2, lactate, SpO2) would be studied | 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 effect of nutritional therapy as per estimated energy requirements versus measured requirements in critically ill ventilated patients with liver cirrhosis on nutritional parameters( NUTRIC score, feed intolerance and would be studied | The nutritional parameters would be assesses at regular intervals maximum upto 28 days |
| The association between energy metabolism, nutritional status and disease severity in patients with CLD | The association between energy metabolism (resting energy expenditure- REE, substrate utilization and macronutrient oxidation), nutritional status (by body composition and anthropometry)and disease severity in patients with CLD (CTP and MELD scores) would be studied | one day (Observational) |