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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2009 by Nizam's Institute of Medical Sciences University, India.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Nizam's Institute of Medical Sciences University, India
ClinicalTrials.gov Identifier:
NCT00890838
First received: April 28, 2009
Last updated: April 29, 2009
Last verified: April 2009

April 28, 2009
April 29, 2009
April 2009
April 2010   (final data collection date for primary outcome measure)
IL-6, 8, 10, HS-CRP [ Time Frame: 5 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00890838 on ClinicalTrials.gov Archive Site
Infectious complications [ Time Frame: 5 days ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Preoperative Intravenous Omega 3 Fatty Acids Administration in Valvular Surgery Patients
Preoperative Intravenous Omega 3 Fatty Acids Administration in Valvular Surgery Patients: A Prospective, Randomized, Open-Label, Comparative Clinical Trial

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
  • Valvular Surgery
  • Inflammation
Dietary Supplement: IVFO-Omegaven
will receive IV Omega 3 fatty acids (Omegaven®) for 3 pre operative days
  • Active Comparator: 1
    will receive IV Omega 3 fatty acids (Omegaven®) for 3 pre operative days
    Intervention: Dietary Supplement: IVFO-Omegaven
  • No Intervention: 2
    will not receive IV Omega 3 fatty acids (Omegaven®) for 3 pre operative days
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
40
June 2010
April 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 50 Years
No
Not Provided
Not Provided
 
NCT00890838
IV Omega3 FA-Valvular Surgery
No
Dr R Gopinath, Nizam's Institute of Medical Sciences University, India
Nizam's Institute of Medical Sciences University, India
Not Provided
Not Provided
Nizam's Institute of Medical Sciences University, India
April 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP