Preoperative Intravenous Omega 3 Fatty Acids Administration in Valvular Surgery Patients

Phase 4

Completed

• Conditions: Valvular Surgery; Inflammation
• Interventions: Dietary Supplement: Omegaven-IV FO

• Registration Number: NCT00890838
• Lead Sponsor: Nizam's Institute of Medical Sciences University, India

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04
• Study First Submitted: 2009-04-28
• Study First Submitted QC: 2009-04-29
• Study First Posted: 2009-04-30
• Primary Completion: 2010-04
• Study Completion: 2010-12
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-01
• Last Update Posted: 2014-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Omegaven	Omegaven-IV FO	will receive IV Omega 3 fatty acids (Omegaven®) for 3 days preoperatively

Primary Outcome Measures

Name	Time	Method
IL-6, 8, 10, HS-CRP	5 days

Secondary Outcome Measures

Name	Time	Method
Infectious complications	5 days

Trial Locations

Locations (1)

NIzam's Institute of Medical Sciences; 🇮🇳 Hyderabad, AP, India