Preoperative Intravenous Omega 3 Fatty Acids Administration in Valvular Surgery Patients

NCT ID: NCT00890838

Last Updated: 2014-10-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-04-30
• Study Completion Date: 2010-12-31

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.

Conditions

Valvular Surgery; Inflammation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Omegaven

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

Group Type: ACTIVE_COMPARATOR

Omegaven-IV FO

Intervention Type: DIETARY_SUPPLEMENT

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

Without Omegaven

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Omegaven-IV FO

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

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nizam's Institute of Medical Sciences University, India

OTHER

Sponsor Role: lead

Responsible Party

Dr. R. Gopinath

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dr R Gopinath

Role: PRINCIPAL_INVESTIGATOR

Professor and Head, Department of ANesthesia and critical care

Locations

NIzam's Institute of Medical Sciences

Hyderabad, Andhra Pradesh, India

Countries

India

Other Identifiers

NIMS/2008/Omegaven/Surgery/02

Identifier Type: -

Identifier Source: org_study_id