NCT02691533

Brief 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) (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:-

  1. 1.Complete clinical examination.
  2. 2.Serum electrolytes- sodium, potassium, calcium, magnesium, phosphate levels
  3. 3.BUN (Blood Urea Nitrogen)
  4. 4.Serum free fatty acid levels
  5. 5.Lipid profile.
  6. 6.Arterial ammonia
  7. 7.Arterial lactate
  8. 8.Blood sugar and serum insulin levels

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

February 15, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 25, 2016

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2017

Completed
Last Updated

September 5, 2018

Status Verified

February 1, 2018

Enrollment Period

1.9 years

First QC Date

February 15, 2016

Last Update Submit

September 1, 2018

Conditions

Chronic Liver Failure

Keywords

Acute

Outcome Measures

Primary Outcomes (1)

  • 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

    5 days

Secondary Outcomes (6)

  • Incidence of sepsis and related complications

    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.

    5 days

  • Influence of lipid infusion (w3/w6) on nitrogen balance.

    5 days

  • Effect of lipid infusion (w3/w6) on International Normalized Ratio (INR).

    5 days

  • Oxidative stress response to lipid infusion

    5 days

  • +1 more secondary outcomes

Study Arms (3)

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

No Lipid Emulsion will be given in this arm

Drug: No Lipid Emulsion/Placebo

Interventions

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/PlaceboDRUG
Placebo Arm

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of liver and Biliary Sciences

New Delhi, National Capital Territory of Delhi, 110070, India

Location

MeSH Terms

Conditions

End Stage Liver Disease

Interventions

Fatty Acids, Unsaturatedsoybean oil, phospholipid emulsion

Condition Hierarchy (Ancestors)

Liver FailureHepatic InsufficiencyLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Fatty AcidsLipids

Study Officials

  • Dr Anand Kulkarni V, MD

    Institute of Liver and Biliary Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 15, 2016

First Posted

February 25, 2016

Study Start

February 1, 2016

Primary Completion

December 31, 2017

Study Completion

December 31, 2017

Last Updated

September 5, 2018

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share

Locations

IN(1)