Preoperative Intravenous Omega 3 Fatty Acids Administration in Valvular Surgery Patients

Preoperative Intravenous Omega 3 Fatty Acids Administration in Valvular Surgery Patients: A Prospective, Randomized, Open-label, Comparative Clinical Trial

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00890838

Acronym

IVFO-Valvular

Enrollment

Registered

2009-04-30

Start date

2009-04-30

Completion date

2010-12-31

Last updated

2014-10-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inflammation, Valvular Surgery

Keywords

IVFO, Inflammation, Valvular surgery, Inflammatory status, Infectious complications

Brief 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.

Interventions

DIETARY_SUPPLEMENTOmegaven-IV FO

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

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

Healthy volunteers

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

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

Design outcomes

Primary

Measure	Time frame
IL-6, 8, 10, HS-CRP	5 days

Secondary

Measure	Time frame
Infectious complications	5 days

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026