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

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ClinicalTrials.gov Identifier: NCT00890838
Recruitment Status : Completed
First Posted : April 30, 2009
Last Update Posted : October 2, 2014
Sponsor:
Information provided by (Responsible Party):
Dr. R. Gopinath, Nizam's Institute of Medical Sciences University, India

Brief 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.

Condition or disease Intervention/treatment Phase
Valvular Surgery Inflammation Dietary Supplement: Omegaven-IV FO Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : April 2009
Primary Completion Date : April 2010
Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. IL-6, 8, 10, HS-CRP [ Time Frame: 5 days ]

Secondary Outcome Measures :
  1. Infectious complications [ Time Frame: 5 days ]


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: April 30, 2009    Key Record Dates
Last Update Posted: October 2, 2014
Last Verified: October 2014

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

Additional relevant MeSH terms:
Inflammation
Pathologic Processes