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

Nizam's Institute of Medical Sciences University, India

Status and phase: Completed; Phase 4

Conditions: Inflammation; Valvular Surgery

Treatments: Dietary Supplement: Omegaven-IV FO

Study type: Interventional

Funder types: Other

Identifiers

NCT00890838

NIMS/2008/Omegaven/Surgery/02

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Omegaven

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Omegaven-IV FO

Without Omegaven

No Intervention group

Description:

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