Preoperative Intravenous Omega 3 Fatty Acids Administration in Valvular Surgery Patients

Inflammation Clinical Trial

— IVFO-Valvular  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00890838
• Other study ID #: NIMS/2008/Omegaven/Surgery/02
• Status: Completed
• Phase: Phase 4
• First received: April 28, 2009
• Last updated: October 1, 2014
• Start date: April 2009
• Est. completion date: December 2010

Study information

• Verified date: October 2014
• Source: Nizam's Institute of Medical Sciences University, India
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Inflammation
• Valvular Surgery

Intervention

Dietary Supplement:
• Omegaven-IV FO
will receive IV Omega 3 fatty acids (Omegaven®) for 3 pre operative days

Locations

Country	Name	City	State
India	NIzam's Institute of Medical Sciences	Hyderabad	AP

Sponsors (1)

Lead Sponsor	Collaborator
Nizam's Institute of Medical Sciences University, India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	IL-6, 8, 10, HS-CRP		5 days	No
Secondary	Infectious complications		5 days	No