Chronic Liver FailureNCT02691533
To Study the Immunomodulating Effects and Safety Profile of ω3 and ω6 PUFA Containing Intravenous Lipid Emulsion in Patients With Acute on Chronic Liver Failure
A study testing ω3 PUFA (Polyunsaturated fatty acids) (10% Omegavan 100 ml) and ω6 PUFA (Polyunsaturated fatty acids) (10% Intralipid 100 ml) in people with Chronic Liver Failure, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
Trial summary
Study population: Patients admitted or seen in OPD (Out Patient Department), Department of Hepatology. Study design- Prospective Randomized Controlled Trial. Study period-January 2016 to May 2017 Intervention- Subjects will be randomized into 3 groups Group A subjects will receive ω3 PUFA (Polyunsaturated Fatty Acids)… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Liver Failure
- What is being tested?
- ω3 PUFA (Polyunsaturated fatty acids) (10% Omegavan 100 ml) and ω6 PUFA (Polyunsaturated fatty acids) (10% Intralipid 100 ml)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteIndia
- Study dates
- 1 Feb 2016to 31 Dec 2017
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Acute on Chronic Liver Failure (ACLF) patients aged 18 years and above
- Patients tolerating enteral nutrition
- Patients with no overt sepsis - no fever, sterile blood and urine cultures, procalcitonin <2
Who cannot join
- Active ongoing GI bleed
- Allergy to soya oil, eggs, peanuts or other ingredients of intralipid.
- Co-morbidities like Diabetes mellitus, hyperlipidemia, CAD and hypothyroidism.
- Renal failure (S.creatinine > 2.5mg%)
- Pregnancy
- Patients with shock requiring vasopressor support
- Patients on anticoagulants
- Refusal to participate in the study
Trial locations and contacts
1 site in 1 country.
India1 site
Institute of liver and Biliary Sciences
New Delhi, National Capital Territory of Delhi, 110070
About this study
Study population: Patients admitted or seen in OPD (Out Patient Department), Department of Hepatology.
Study design- Prospective Randomized Controlled Trial. Study period-January 2016 to May 2017 Intervention- Subjects will be randomized into 3 groups Group A subjects will receive ω3 PUFA (Polyunsaturated Fatty Acids) (10% Omegavan 100 ml).
Read more
Group B- will receive ω6 PUFA (Polyunsaturated Fatty Acids) (10% Intralipid 100 ml).
Group C -Placebo group
Monitoring and assessment- :- The following tests will be done in these patients:-
- Complete clinical examination.
- Serum electrolytes- sodium, potassium, calcium, magnesium, phosphate levels
- BUN (Blood Urea Nitrogen)
- Serum free fatty acid levels
- Lipid profile.
- Arterial ammonia
- Arterial lactate
- Blood sugar and serum insulin levels
- Conditions
- Chronic Liver Failure
- Being tested
- ω3 PUFA (Polyunsaturated fatty acids) (10% Omegavan 100 ml), ω6 PUFA (Polyunsaturated fatty acids) (10% Intralipid 100 ml), No Lipid Emulsion/Placebo
- Keywords
- Acute
- Medical subject headings
- End Stage Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ω3 PUFA (Polyunsaturated fatty acids) (10% Omegavan 100 ml)Drug
ω6 PUFA (Polyunsaturated fatty acids) (10% Intralipid 100 ml)Drug
No Lipid Emulsion/PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| ω3 PUFA(10% Omegavan 100 ml) | Experimental | Not described Receives: Drug: ω3 PUFA (Polyunsaturated fatty acids) (10% Omegavan 100 ml) |
| ω6 PUFA (20% Intralipid 50 ml) | Experimental | Not described Receives: Drug: ω6 PUFA (Polyunsaturated fatty acids) (10% Intralipid 100 ml) |
| Placebo Arm | Placebo comparator | No Lipid Emulsion will be given in this arm Receives: Drug: No Lipid Emulsion/Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of intravenous lipid emulsions (w3/ w6) on systemic inflammation and endotoxemia levels at the end of 5 days.
Decrease in endotoxins levels , TNF alpha,ilnterleukin 6,ilnterleukin 10,Monocyte/ macrophage activation etc.
All of them are markers of inflammation. The outcome systemic inflammation is a composite outcome which includes all the above mentioned markers
Measured: 5 days
Secondary outcomes (6)
Incidence of sepsis and related complications
Measured: 28 days
Effect of lipid infusion (w3/w6) on metabolic parameters viz., serum triglyceride levels, serum ketone levels, free fatty acid levels and arterial lactate levels.
Metabolic parameter is a composite outcome of all the above said markers.
Measured: 5 days
Influence of lipid infusion (w3/w6) on nitrogen balance.
Improvement or deterioration in urinary urea nitrogen.
Measured: 5 days
Effect of lipid infusion (w3/w6) on International Normalized Ratio (INR).
Effect is defined as INR (International Normalized Ratio) value within normal limit or improvement as compare to baseline value.
Measured: 5 days
Oxidative stress response to lipid infusion
Oxidative stress response is based on the Improvement or deterioration in Isoprostane levels in urine
Measured: 5 days
Influence of lipid infusion(w3/w6) on 28day mortality
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2016 (estimated)
- Study start1 Feb 2016
- Primary completion31 Dec 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Liver FailureStudies 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
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Liver and Biliary Sciences, India
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr Anand Kulkarni V, MD, Principal investigator, Institute of Liver and Biliary Sciences, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02691533
- Sponsor's protocol ID
- ILBS-ACLF-006
- Status last verified
- Feb 2018
- First submitted
- 15 Feb 2016
- Last updated
- 5 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Study the Immunomodulating Effects and Safety Profile of ω3 and ω6 PUFA Containing Intravenous Lipid Emulsion in Patients With Acute on Chronic Liver Failure
- ClinicalTrials.gov ID
- NCT02691533
- Acronym / sponsor ID
- ILBS-ACLF-006
- Conditions
- Chronic Liver Failure
- Keywords
- Acute
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- 1 Feb 2016 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 25 Feb 2016 (estimated)
- 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.
Study population: Patients admitted or seen in OPD (Out Patient Department), Department of Hepatology.
Study design- Prospective Randomized Controlled Trial. Study period-January 2016 to May 2017 Intervention- Subjects will be randomized into 3 groups Group A subjects will receive ω3 PUFA (Polyunsaturated Fatty Acids) (10% Omegavan 100 ml).
Group B- will receive ω6 PUFA (Polyunsaturated Fatty Acids) (10% Intralipid 100 ml).
Group C -Placebo group
Monitoring and assessment- :- The following tests will be done in these patients:-
- Complete clinical examination.
- Serum electrolytes- sodium, potassium, calcium, magnesium, phosphate levels
- BUN (Blood Urea Nitrogen)
- Serum free fatty acid levels
- Lipid profile.
- Arterial ammonia
- Arterial lactate
- Blood sugar and serum insulin levels
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ω3 PUFA(10% Omegavan 100 ml) | Experimental | Drug: ω3 PUFA (Polyunsaturated fatty acids) (10% Omegavan 100 ml) |
| ω6 PUFA (20% Intralipid 50 ml) | Experimental | Drug: ω6 PUFA (Polyunsaturated fatty acids) (10% Intralipid 100 ml) |
| Placebo Arm | Placebo comparator | Drug: No Lipid Emulsion/PlaceboNo Lipid Emulsion will be given in this arm |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Acute on Chronic Liver Failure (ACLF) patients aged 18 years and above
- Patients tolerating enteral nutrition
- Patients with no overt sepsis - no fever, sterile blood and urine cultures, procalcitonin <2
Key exclusion criteria (8 listed)
- Active ongoing GI bleed
- Allergy to soya oil, eggs, peanuts or other ingredients of intralipid.
- Co-morbidities like Diabetes mellitus, hyperlipidemia, CAD and hypothyroidism.
- Renal failure (S.creatinine > 2.5mg%)
- Pregnancy
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 |
|---|---|---|
| ω3 PUFA (Polyunsaturated fatty acids) (10% Omegavan 100 ml) | Drug | ω3 PUFA(10% Omegavan 100 ml) |
| ω6 PUFA (Polyunsaturated fatty acids) (10% Intralipid 100 ml) | Drug | ω6 PUFA (20% Intralipid 50 ml) |
| No Lipid Emulsion/Placebo | Drug | Placebo Arm |
Primary outcome
Effect of intravenous lipid emulsions (w3/ w6) on systemic inflammation and endotoxemia levels at the end of 5 days.
Time frame: 5 days
Decrease in endotoxins levels , TNF alpha,ilnterleukin 6,ilnterleukin 10,Monocyte/ macrophage activation etc. All of them are markers of inflammation. The outcome systemic inflammation is a composite outcome which includes all the above mentioned markers
6 secondary outcomes
Incidence of sepsis and related complications
Time frame: 28 days
Effect of lipid infusion (w3/w6) on metabolic parameters viz., serum triglyceride levels, serum ketone levels, free fatty acid levels and arterial lactate levels.
Time frame: 5 days
Influence of lipid infusion (w3/w6) on nitrogen balance.
Time frame: 5 days
Effect of lipid infusion (w3/w6) on International Normalized Ratio (INR).
Time frame: 5 days
Oxidative stress response to lipid infusion
Time frame: 5 days
Influence of lipid infusion(w3/w6) on 28day mortality
Time frame: 28 days
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 5 Sep 2018.
- Individual participant dataSharing planned: No
Related trials for Chronic Liver Failure
Not yet recruiting
Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
Acute-on-Chronic Liver Failure (ACLF)
Not yet recruiting
Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
Acute-on-Chronic Liver Failure (ACLF)
Active, not recruiting
LiverPAL: A Trial of Inpatient Palliative Care for Patients With Advanced Liver Disease
Liver Disease Chronic, End Stage Liver DIsease
RecruitingObservational study
Establishing a Reference Framework for Outcomes After Machine-Preserved Liver Transplantation in Europe
End-stage Liver Disease (ESLD), Acute Liver Failure
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Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
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.
Dr Anand Kulkarni V, MD principal investigator
Institute of Liver and Biliary Sciences, India
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ω3 PUFA (Polyunsaturated fatty acids) (10% Omegavan 100 ml) and ω6 PUFA (Polyunsaturated fatty acids) (10% Intralipid 100 ml) in people with Chronic Liver Failure, 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 3 inclusion and 8 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 5 Sep 2018. 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. Some participants in this study may receive a placebo. 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?
Effect of intravenous lipid emulsions (w3/ w6) on systemic inflammation and endotoxemia levels at the end of 5 days. (time frame: 5 days). 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 5 Sep 2018.