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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr. R. Gopinath, Nizam's Institute of Medical Sciences University, India
ClinicalTrials.gov Identifier:
NCT00890838
First received: April 28, 2009
Last updated: October 1, 2014
Last verified: October 2014

April 28, 2009
October 1, 2014
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: Omegaven-IV FO
will receive IV Omega 3 fatty acids (Omegaven®) for 3 pre operative days
  • Active Comparator: Omegaven
    will receive IV Omega 3 fatty acids (Omegaven®) for 3 days preoperatively
    Intervention: Dietary Supplement: Omegaven-IV FO
  • No Intervention: Without Omegaven
    will not receive IV Omega 3 fatty acids (Omegaven®) for 3 days preoperativel
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
December 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
Contact information is only displayed when the study is recruiting subjects
India
 
NCT00890838
NIMS/2008/Omegaven/Surgery/02
No
Dr. R. Gopinath, Nizam's Institute of Medical Sciences University, India
Nizam's Institute of Medical Sciences University, India
Not Provided
Principal Investigator: Dr R Gopinath Professor and Head, Department of ANesthesia and critical care
Nizam's Institute of Medical Sciences University, India
October 2014

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