Liver CirrhosesMETALICNCT03871894
Indirect Calorimeter Based Study in Patients With Liver Cirrhosis
A study testing Indirect calorimetry based nutritional intervention till patient in ICU(Intensive care unit) and Standard and fixed nutritional intervention till patient in ICU in people with Liver Cirrhoses, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Liver Cirrhoses
- What is being tested?
- Indirect calorimetry based nutritional intervention till patient in ICU(Intensive care unit) and Standard and fixed nutritional intervention till patient in ICU
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 1 siteIndia
- Study dates
- 12 Mar 2019to 31 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 22Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Liver Cirrhoses
- Being tested
- Indirect calorimetry based nutritional intervention till patient in ICU(Intensive care unit), Standard and fixed nutritional intervention till patient in ICU
- Keywords
- Indirect calorimeter, Resting energy expenditure, substrate utilization, nitrogen balance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
Standard and fixed nutritional intervention till patient in ICUOther
Fixed standard nutritional therapy 35-40 Kcal/Kg IBW/day and 1.5 g protein /Kg IBW/Day till patient on ventilator
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Indirect calorimetry based nutritional intervention till patient in ICU(Intensive care unit); Other: Standard and fixed nutritional intervention till patient in ICU |
| 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. Receives: Other: Indirect calorimetry based nutritional intervention till patient in ICU(Intensive care unit); Other: Standard and fixed nutritional intervention till patient in ICU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1: An Observational study
Study groups :
- Healthy controls
- Disease Groups
- Patients with liver cirrhosis (compensated and decompensated)
- Critically ill cirrhotics on mechanical ventilator support
- patients with chronic kidney disease (CKD) (stable,non dialyzed, non oliguric outpatients)
- Critically ill patients with Acute liver failure (ALF) on mechanical ventilator support
- Critically ill patients with Acute on chronic liver failure(ACLF) on mechanical ventilator support
- Severe acute pancreatitis on mechanical ventilator support
Comparison of the prevalence of hyper and hypo metabolism in patients with chronic liver disease(CLD) and healthy controls and other disease groups.
Measured: 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
Measured: 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 (6)
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
Measured: The metabolic parameters would be assessed at the baseline, Day 7 and at Day 15 of enrollment
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: one day (Observational)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2019
- Study start12 Mar 2019
- Primary completion31 Aug 2022
- Study completion31 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CirrhosesStudies of the same condition, open and under way.
- More trials run by Institute of Liver and Biliary Sciences, IndiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Liver and Biliary Sciences, India
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jaya Benjamin, Msc,PhD, Study director, Institute of Liver and Biliary Sciences, sector D-1, Vasantkunj, New Delhi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03871894
- Sponsor's protocol ID
- ILBS-METALIC01
- Acronym
- METALIC
- Status last verified
- Sep 2022
- First submitted
- 26 Feb 2019
- Last updated
- 24 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03871894
- Acronym / sponsor ID
- METALIC / ILBS-METALIC01
- Conditions
- Liver Cirrhoses
- Keywords
- Indirect calorimeter, Resting energy expenditure, substrate utilization, nitrogen balance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- 12 Mar 2019 (actual)
- Primary completion
- 31 Aug 2022 (actual)
- Study completion
- 31 Aug 2022 (actual)
- First posted
- 12 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control arm | Active comparator | Other: Indirect calorimetry based nutritional intervention till patient in ICU(Intensive care unit), Other: Standard and fixed nutritional intervention till patient in ICUThis 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. |
| Intervention arm | Experimental | Other: Indirect calorimetry based nutritional intervention till patient in ICU(Intensive care unit), Other: Standard and fixed nutritional intervention till patient in ICUThis 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
- 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 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
Key exclusion criteria (22 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Indirect calorimetry based nutritional intervention till patient in ICU(Intensive care unit)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 | Other | Control arm, Intervention arm |
| Standard and fixed nutritional intervention till patient in ICUFixed standard nutritional therapy 35-40 Kcal/Kg IBW/day and 1.5 g protein /Kg IBW/Day till patient on ventilator | Other | Control arm, Intervention arm |
Primary outcome
Part 1: An Observational study
Time frame: One day (Observational)
Study groups : 1. Healthy controls 2. Disease Groups * Patients with liver cirrhosis (compensated and decompensated) * Critically ill cirrhotics on mechanical ventilator support * patients with chronic kidney disease (CKD) (stable,non dialyzed, non oliguric outpatients) * Critically ill patients with Acute liver failure (ALF) on mechanical ventilator support * Critically ill patients with Acute on chronic liver failure(ACLF) on mechanical ventilator support * Severe acute pancreatitis on mechanical ventilator support Comparison of the prevalence of hyper and hypo metabolism in patients with chronic liver disease(CLD) and healthy controls and other disease groups.
Part 2: A Randomized controlled trial
Time frame: 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.
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
6 secondary outcomes
Change in metabolic profile
Time frame: The metabolic parameters would be assessed at the baseline, Day 7 and at Day 15 of enrollment
Change in inflammatory milieu
Time frame: The inflammatory markers would be assessed at the baseline, Day 7 and at Day 15 of enrollment
Change in clinical parameters
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: one day (Observational)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2022.
Related trials for Liver Cirrhoses
RecruitingPhase 4
Optimizing Portal Hypertension With TIPS and Interval Metabolic Surgery for Advanced Liver Disease
Liver Cirrhoses, Portal Hypertension Related to Cirrhosis
Not yet recruiting
The Application of Lifestyle Enhancing Validated Integrative Therapies for Everyday Pain in Cirrhosis
Cirrhoses, Liver
RecruitingPhase 4
Role of Allopurinol in Prevention of Complications Related to Decompensated Cirrhosis of Liver
Cirrhoses, Liver, Decompensated Cirrhosis of Liver
Not yet recruitingObservational study
Detecting Liver Fibrosis in Patients At-risk
Fatty Liver, NAFLD - Non-Alcoholic Fatty Liver Disease
Active, not recruitingObservational study
Appropriate Management of Hepatic EncePhalopaThy AmonG cirrhOtic patieNts Admitted to Internal Medicine
Cirrhoses, Liver, Portal Hypertension Related to Cirrhosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jaya Benjamin, Msc,PhD study director
Institute of Liver and Biliary Sciences, sector D-1, Vasantkunj, New Delhi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Indirect calorimetry based nutritional intervention till patient in ICU(Intensive care unit) and Standard and fixed nutritional intervention till patient in ICU in people with Liver Cirrhoses, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part 1: An Observational study (time frame: One day (Observational)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2022.