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CompletedNCT00890838IVFO-ValvularUpdated Oct 2, 2014

Preoperative Intravenous Omega 3 Fatty Acids Administration in Valvular Surgery Patients

A Phase 4 interventional study of Omegaven-IV FO in Valvular Surgery and Inflammation, sponsored by Nizam's Institute of Medical Sciences University, India. Completed at 1 site in India. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2014-10-02.

Sponsored by Nizam's Institute of Medical Sciences University, India · Phase 4, Interventional, and Supportive care

Phase
Phase 4
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
01

Study summary

The perioperative administration of n-3 fatty acids has been shown to lead to favorable effects on outcome in patients with severe surgical interventions by lowering the magnitude of inflammatory response and by modulating the immune response. To the investigators' knowledge, no study with preoperative administration of intravenous (IV) omega 3 fatty acids as a part of total parenteral nutrition (TPN) or monotherapy with it to demonstrate its effects on inflammatory and immune response has been conducted. So, this study has been planned to judge the inflammatory response of preoperative monotherapy with IV omega 3 fatty acids in elderly patients undergoing valvular surgery considering the hyperinflammation associated with this type of surgery in elderly patients.

02

Conditions studied

  • Valvular Surgery
  • Inflammation

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Keywords

  • IVFO
  • Inflammation
  • Valvular surgery
  • Inflammatory status
  • Infectious complications
03

In context

Inflammation

3,439 studies on the registry are indexed under Inflammation; 629 are open to participants now.

This study's enrollment of 40 is below the median of 50 across 2,437 interventional studies indexed under Inflammation.

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Lead sponsor

Nizam's Institute of Medical Sciences University, India is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Adult male or female patients undergoing valvular surgeries
  2. Age 18-50 years
  3. The patients who give written informed consent

Exclusion criteria

Exclusion Criteria:

  1. Refusal to participate in the study
  2. Allergy to any of the constituents of nutritional products
  3. HIV positive patients, patients with primary diagnosis of hypertriglyceridemia, patients on long term steroid therapy and cycloxygenase inhibitors (more than 3 months)
  4. Severe cardiac disease, hepatic disorders (total bilirubin > 1.5 times the upper limit of normal), psychiatric disorders likely to affect compliance, severe hemorrhagic disorders, stroke, embolism
  5. Uncontrolled severe renal failure (Serum creatinine > 2 mg/dL) without dialysis/hemofiltration
  6. Pregnant or nursing women
  7. Participation in any other clinical trial within the last 2 months
05

Study design

Phase
Phase 4
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (actual)

Study arms

  • Active comparator
    Omegaven

    will receive IV Omega 3 fatty acids (Omegaven®) for 3 days preoperatively

    Dietary Supplement: Omegaven-IV FO

  • No intervention
    Without Omegaven

    will not receive IV Omega 3 fatty acids (Omegaven®) for 3 days preoperativel

Interventions

  • Dietary supplementOmegaven-IV FO

    will receive IV Omega 3 fatty acids (Omegaven®) for 3 pre operative days

06

What researchers measure

Primary outcomes

  1. IL-6, 8, 10, HS-CRP

    Time frame: 5 days

Secondary outcomes

  1. Infectious complications

    Time frame: 5 days

07

Study locations

1 site
  • NIzam's Institute of Medical Sciences
    Hyderabad, AP, India
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 2, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00890838
Lead sponsor
Nizam's Institute of Medical Sciences University, India
Responsible party
Dr. R. Gopinath (Professor, Nizam's Institute of Medical Sciences University, India) — Principal investigator
First posted
Apr 30, 2009
Start date
Apr 2009
Primary completion
Apr 2010
Completion
Dec 2010
Last update
Oct 2, 2014

Study contacts

Dr R Gopinath
principal investigator · Professor and Head, Department of ANesthesia and critical care

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2014. You cannot join it, but the record below documents what was studied.

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