Alcoholic Liver DiseaseNCT02381769
THE IMMUNOLOGICAL EFFECTS AND METABOLIC TOLERANCE OF LIPID INFUSION IN PATIENTS WITH CIRRHOSIS.
A study testing Soybean based lipid emulsion in people with Alcoholic Liver Disease, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
Trial summary
The study will be an experimental pre-post trial in which patients with ethanol related liver disease (both severe alcoholic hepatitis and decompensated ) admitted in our institute from Jun 2013-Dec 2014 will be enrolled in the study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcoholic Liver Disease
- What is being tested?
- Soybean based lipid emulsion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteIndia
- Study dates
- Jun 2013to Dec 2014
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Active ongoing Gastrointestinal bleed.
- Unresolved sepsis
- Allergy to soya oil, eggs, peanuts or other ingredients of intralipid.
- Co-morbidities like Diabetes mellitus, hyperlipidemia, Coronary Artery Disease (CAD) and hypothyroidism.
- Renal failure (S.creatinine > 1.5mg %)
- Pregnancy
- Patients on high inotropic support (requiring more than 1 inotropic support)
- Refusal to participate in the study
Trial locations and contacts
1 site in 1 country.
India1 site
Institute of Liver & Biliary Sciences
New Delhi, National Capital Territory of Delhi, 110070
About this study
The study will be an experimental pre-post trial in which patients with ethanol related liver disease (both severe alcoholic hepatitis and decompensated ) admitted in our institute from Jun 2013-Dec 2014 will be enrolled in the study. Those on ryle's tube feeding would receive polymeric blenderized kitchen based liquid diet while those tolerating orally would receive soft/ solid diet as tolerated as per requirement. All the patients would receive same amount of calories i.e., 30-35 kcal/kg ideal body weight/ day and 1-1.2 gm/kg protein. 35-40% of non protein calorie would be provided as fats and rest of the calories will be provided as carbohydrates. All patients will be transfused 250ml of 20% intra lipid per day for 3 consecutive days, over and above the feed provided to them to be taken enterally (orally or through Ryle's Tube). Patients will undergo tests prior to infusion and 72 hours after infusion.
- Conditions
- Alcoholic Liver Disease
- Being tested
- Soybean based lipid emulsion
- Medical subject headings
- Liver Diseases, Alcoholic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Soybean based lipid emulsionDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Parenteral Nutrition | Experimental | Soybean based lipid emulsion Receives: Dietary Supplement: Soybean based lipid emulsion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of intravenous lipid on monocytes counts.
Measured: 3 days
Effect of intravenous lipid on neutrophils counts.
Measured: 3 days
Effect of intravenous lipid on macrophages count.
Measured: 3 days
Secondary outcomes (8)
Influence of lipid infusion on TEG (Thromboelastography)
Measured: 3 days
Influence of lipid infusion on TNF-α (Tumor Necrosis Factor).
Measured: 3 days
Influence of lipid infusion on interleukin levels (IL-6, IL-10).
Measured: 3 days
Influence of lipid infusion on PT/INR
Measured: 3 days
Influence of lipid infusion on PTT.
Measured: 3 days
Influence of lipid infusion on liver parameters.
Measured: 3 days
Influence of lipid infusion on arterial ammonia.
Measured: 3 days
Influence of lipid infusion on renal parameters.
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2015 (estimated)
- Study startJun 2013
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcoholic Liver DiseaseStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Liver and Biliary Sciences, India
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02381769
- Sponsor's protocol ID
- ILBS-lipid infusion-01
- Status last verified
- Dec 2014
- First submitted
- 23 Feb 2015
- Last updated
- 12 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THE IMMUNOLOGICAL EFFECTS AND METABOLIC TOLERANCE OF LIPID INFUSION IN PATIENTS WITH CIRRHOSIS.
- ClinicalTrials.gov ID
- NCT02381769
- Acronym / sponsor ID
- ILBS-lipid infusion-01
- Conditions
- Alcoholic Liver Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 6 Mar 2015 (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.
The study will be an experimental pre-post trial in which patients with ethanol related liver disease (both severe alcoholic hepatitis and decompensated ) admitted in our institute from Jun 2013-Dec 2014 will be enrolled in the study. Those on ryle's tube feeding would receive polymeric blenderized kitchen based liquid diet while those tolerating orally would receive soft/ solid diet as tolerated as per requirement. All the patients would receive same amount of calories i.e., 30-35 kcal/kg ideal body weight/ day and 1-1.2 gm/kg protein. 35-40% of non protein calorie would be provided as fats and rest of the calories will be provided as carbohydrates. All patients will be transfused 250ml of 20% intra lipid per day for 3 consecutive days, over and above the feed provided to them to be taken enterally (orally or through Ryle's Tube). Patients will undergo tests prior to infusion and 72 hours after infusion.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Parenteral Nutrition | Experimental | Dietary Supplement: Soybean based lipid emulsionSoybean based lipid emulsion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (8 listed)
- Active ongoing Gastrointestinal bleed.
- Unresolved sepsis
- Allergy to soya oil, eggs, peanuts or other ingredients of intralipid.
- Co-morbidities like Diabetes mellitus, hyperlipidemia, Coronary Artery Disease (CAD) and hypothyroidism.
- Renal failure (S.creatinine > 1.5mg %)
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 |
|---|---|---|
| Soybean based lipid emulsion | Dietary supplement | Parenteral Nutrition |
Primary outcome
Effect of intravenous lipid on monocytes counts.
Time frame: 3 days
Effect of intravenous lipid on neutrophils counts.
Time frame: 3 days
Effect of intravenous lipid on macrophages count.
Time frame: 3 days
8 secondary outcomes
Influence of lipid infusion on TEG (Thromboelastography)
Time frame: 3 days
Influence of lipid infusion on TNF-α (Tumor Necrosis Factor).
Time frame: 3 days
Influence of lipid infusion on interleukin levels (IL-6, IL-10).
Time frame: 3 days
Influence of lipid infusion on PT/INR
Time frame: 3 days
Influence of lipid infusion on PTT.
Time frame: 3 days
Influence of lipid infusion on liver parameters.
Time frame: 3 days
Influence of lipid infusion on arterial ammonia.
Time frame: 3 days
Influence of lipid infusion on renal parameters.
Time frame: 3 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 12 Sep 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Soybean based lipid emulsion in people with Alcoholic Liver Disease, 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 0 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 12 Sep 2016. 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?
Effect of intravenous lipid on monocytes counts. (time frame: 3 days). The study lists 3 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 12 Sep 2016.