IVFO-Valvular: Preoperative Intravenous Omega 3 Fatty Acids Administration in Valvular Surgery Patients

Sponsor

Nizam's Institute of Medical Sciences University, India (Other)

Overall Status

Completed

CT.gov ID

NCT00890838

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Valvular Surgery Inflammation	Dietary Supplement: Omegaven-IV FO	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Study Start Date :

Apr 1, 2009

Actual Primary Completion Date :

Apr 1, 2010

Actual Study Completion Date :

Dec 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Omegaven will receive IV Omega 3 fatty acids (Omegaven®) for 3 days preoperatively	Dietary Supplement: Omegaven-IV FO will receive IV Omega 3 fatty acids (Omegaven®) for 3 pre operative days
No Intervention: Without Omegaven will not receive IV Omega 3 fatty acids (Omegaven®) for 3 days preoperativel

Arm

Intervention/Treatment

Active Comparator: Omegaven

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

Dietary Supplement: Omegaven-IV FO

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

No Intervention: Without Omegaven

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

Outcome Measures

Primary Outcome Measures

IL-6, 8, 10, HS-CRP [5 days]

Secondary Outcome Measures

Infectious complications [5 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

Refusal to participate in the study
Allergy to any of the constituents of nutritional products
HIV positive patients, patients with primary diagnosis of hypertriglyceridemia, patients on long term steroid therapy and cycloxygenase inhibitors (more than 3 months)
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
Uncontrolled severe renal failure (Serum creatinine > 2 mg/dL) without dialysis/hemofiltration
Pregnant or nursing women
Participation in any other clinical trial within the last 2 months