Back to resultsPreoperative Intravenous Omega 3 Fatty Acids Administration in Valvular Surgery Patients (IVFO-Valvular)
Primary Purpose
Valvular Surgery, Inflammation
Status
Completed
Phase
Phase 4
Locations
India
Study Type
Interventional
Intervention
Omegaven-IV FO
Sponsored by
About this trial
This is an interventional supportive care trial for Valvular Surgery focused on measuring IVFO, Inflammation, Valvular surgery, Inflammatory status, Infectious complications
Eligibility Criteria
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
Sites / Locations
- NIzam's Institute of Medical Sciences
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Omegaven
Without Omegaven
Arm Description
will receive IV Omega 3 fatty acids (Omegaven®) for 3 days preoperatively
will not receive IV Omega 3 fatty acids (Omegaven®) for 3 days preoperativel
Outcomes
Primary Outcome Measures
IL-6, 8, 10, HS-CRP
Secondary Outcome Measures
Infectious complications
Full Information
NCT ID
NCT00890838
First Posted
April 28, 2009
Last Updated
October 1, 2014
Sponsor
Nizam's Institute of Medical Sciences University, India
1. Study Identification
Unique Protocol Identification Number
NCT00890838
Brief Title
Preoperative Intravenous Omega 3 Fatty Acids Administration in Valvular Surgery Patients
Acronym
IVFO-Valvular
Official Title
Preoperative Intravenous Omega 3 Fatty Acids Administration in Valvular Surgery Patients: A Prospective, Randomized, Open-label, Comparative Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nizam's Institute of Medical Sciences University, India
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Valvular Surgery, Inflammation
Keywords
IVFO, Inflammation, Valvular surgery, Inflammatory status, Infectious complications
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Omegaven
Arm Type
Active Comparator
Arm Description
will receive IV Omega 3 fatty acids (Omegaven®) for 3 days preoperatively
Arm Title
Without Omegaven
Arm Type
No Intervention
Arm Description
will not receive IV Omega 3 fatty acids (Omegaven®) for 3 days preoperativel
Intervention Type
Dietary Supplement
Intervention Name(s)
Omegaven-IV FO
Intervention Description
will receive IV Omega 3 fatty acids (Omegaven®) for 3 pre operative days
Primary Outcome Measure Information:
Title
IL-6, 8, 10, HS-CRP
Time Frame
5 days
Secondary Outcome Measure Information:
Title
Infectious complications
Time Frame
5 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr R Gopinath
Organizational Affiliation
Professor and Head, Department of ANesthesia and critical care
Official's Role
Principal Investigator
Facility Information:
Facility Name
NIzam's Institute of Medical Sciences
City
Hyderabad
State/Province
AP
Country
India
12. IPD Sharing Statement
Learn more about this trial
Preoperative Intravenous Omega 3 Fatty Acids Administration in Valvular Surgery Patients
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