Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
  Purpose

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 Intervention Phase
Valvular Surgery
Inflammation
Dietary Supplement: Omegaven-IV FO
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Nizam's Institute of Medical Sciences University, India:

Primary Outcome Measures:
  • IL-6, 8, 10, HS-CRP [ Time Frame: 5 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Infectious complications [ Time Frame: 5 days ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: April 2009
Study Completion Date: December 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00890838

Locations
India
NIzam's Institute of Medical Sciences
Hyderabad, AP, India
Sponsors and Collaborators
Nizam's Institute of Medical Sciences University, India
Investigators
Principal Investigator: Dr R Gopinath Professor and Head, Department of ANesthesia and critical care
  More Information

No publications provided

Responsible Party: Dr. R. Gopinath, Professor, Nizam's Institute of Medical Sciences University, India
ClinicalTrials.gov Identifier: NCT00890838     History of Changes
Other Study ID Numbers: NIMS/2008/Omegaven/Surgery/02
Study First Received: April 28, 2009
Last Updated: October 1, 2014
Health Authority: India: Institutional Review Board

Keywords provided by Nizam's Institute of Medical Sciences University, India:
IVFO
Inflammation
Valvular surgery
Inflammatory status
Infectious complications

Additional relevant MeSH terms:
Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on November 20, 2014