- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00890838
Preoperative Intravenous Omega 3 Fatty Acids Administration in Valvular Surgery Patients (IVFO-Valvular)
October 1, 2014 updated by: Dr. R. Gopinath, Nizam's Institute of Medical Sciences University, India
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
AP
-
Hyderabad, AP, India
- NIZAM'S Institute of Medical Sciences
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Adult male or female patients undergoing valvular surgeries
- Age 18-50 years
- The patients who give written informed consent
Exclusion Criteria:
- Refusal to participate in the study
- Allergy to any of the constituents of nutritional products
- HIV positive patients, patients with primary diagnosis of hypertriglyceridemia, patients on long term steroid therapy and cycloxygenase inhibitors (more than 3 months)
- 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
- Uncontrolled severe renal failure (Serum creatinine > 2 mg/dL) without dialysis/hemofiltration
- Pregnant or nursing women
- Participation in any other clinical trial within the last 2 months
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Omegaven
will receive IV Omega 3 fatty acids (Omegaven®) for 3 days preoperatively
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
IL-6, 8, 10, HS-CRP
Time Frame: 5 days
|
5 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Infectious complications
Time Frame: 5 days
|
5 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Dr R Gopinath, Professor and Head, Department of ANesthesia and critical care
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2009
Primary Completion (Actual)
April 1, 2010
Study Completion (Actual)
December 1, 2010
Study Registration Dates
First Submitted
April 28, 2009
First Submitted That Met QC Criteria
April 29, 2009
First Posted (Estimate)
April 30, 2009
Study Record Updates
Last Update Posted (Estimate)
October 2, 2014
Last Update Submitted That Met QC Criteria
October 1, 2014
Last Verified
October 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NIMS/2008/Omegaven/Surgery/02
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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