Status:
COMPLETED
Indirect Calorimeter Based Study in Patients With Liver Cirrhosis
Lead Sponsor:
Institute of Liver and Biliary Sciences, India
Conditions:
Liver Cirrhoses
Eligibility:
All Genders
18-70 years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 12 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2022
Estimated Enrollment :
83 Patients enrolled
Trial Details
Trial ID
NCT03871894
Start Date
March 12 2019
End Date
August 31 2022
Last Update
October 24 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
ILBS
New Delhi, National Capital Territory of Delhi, India, 110070