Health Condition 1: K721- Chronic hepatic failure
Conditions
Interventions
Intervention1: Measured calorie delivery: Calorie delivery as per measured energy requirements using Indirect calorimeter
Control Intervention1: Estimated Calorie delivery: Calorie delivery as per est
Sponsors
ICMR
Eligibility
Inclusion criteria
Inclusion criteria: 1.Eligible for enteral feeding with a functional gastrointestinal tract (with or without SPN) 2.Mechanically ventilated patients expected to be on ventilator support for at least 5 days 3.Expected length of ICU stay greater than 3 days 4.Initiated on nutrition support (parenteral/or enteral nutrition) 5.The diagnosis documented by physician within one day of ICU admit 6. Signed informed consent
Exclusion criteria
Exclusion criteria: 1.Active upper gastrointestinal bleeding 2.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. 3. Pregnant women 4. Refused to consent/ inability to obtain informed consent 5.Known long standing diabetic 6. If there is any evidence of medical/surgical instability 7. Hepatocellular carcinoma Extrahepatic malignancies 8. Those receiving total parenteral (TPN) 9. With persistent gastrointestinal dysfunction and ileus 10. Readmitted to the ICU 11. Terminally ill patients on high inotropic (triple) support 12. Acute liver failure 13. If there is any evidence of medical/surgical instability 14. If patients are taking any portion of nutrition by mouth 15. Patient on CRRT- continuous renal replacement therapy for more than 48 hours oICU admission 16. Severe co morbidities such as CKD requiring maintenance dialysis, COPD ancardiac pathologies. 17.Moribund patient with likely survival 18. Patients enrolled in other drug trials
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the effect of nutritional therapy as per measured versus estimated energy requirements in critically ill ventilated patients with cirrhosis on duration of mechanical ventilationTimepoint: From date of enrollment until the date of ICU discharge /LAMA discharge, date of death from any cause, or off ventilatory support whichever comes first, assessed up to 28 days. | — |
Secondary
| Measure | Time frame |
|---|---|
| To study the effect of nutritional therapy as per measured versus estimated energy requirements in critically ill ventilated patients with cirrhosis on the Clinical parameters (development of new onset infection, resolution of sepsis, renal function and length of stay in the ICUTimepoint: 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.;To study the effect of nutritional therapy as per measured versus estimated energy requirements in critically ill ventilated patients with cirrhosis on the inflammatory markers (tumor necrosis factor, interleukin 6 and C-reactive protein)Timepoint: The inflammatory markers would be assessed at the baseline, Day 7 and at Day 15 of enrollment;To study the effect of nutritional therapy as per measured versus estimated energy requirements in critically ill ventilated patients with cirrhosis on the nutritional parameters (NUTRIC score, feed intolerance,nitrogen balance, anthropometry, muscle mass by CT if done during ICU stay)Timepoint: Feed intolerance would be assessed daily; NUTRIC score and anthropometry would be done at baseline, Day 7 and Day 15; Nitrogen balance would be done at baseline, Day4, Day 7, Day 10 and Day 15; muscle mass would be assessed once if CT abdomen is available during ICU stay;To study the effect of nutritional therapy as per measured versus estimated energy requirements in critically ill ventilated patients with cirrhosis on the metabolic profile (Insulin resistance, non esterified fatty acids levels, amino acid profile, ketone bodies in blood)Timepoint: The metabolic parameters would be assessed at the baseline, Day 7 and at Day 15 of enrollment;To study the effect of nutritional therapy as per measured versus estimated energy requirements in critically ill ventilated patients with liver cirrhosis on the ventilatory and arteri | — |
Countries
India
Contacts
Public ContactDr Jaya Benjamin
Institute of Liver and Biliary Sciences
Outcome results
None listed