Preoperative Intravenous Omega 3 Fatty Acids Administration in Elderly Patients Undergoing Hip Surgery
The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2009 by Nizam's Institute of Medical Sciences University, India.
Recruitment status was Not yet recruiting
Recruitment status was Not yet recruiting
Sponsor:
Nizam's Institute of Medical Sciences University, India
Information provided by:
Nizam's Institute of Medical Sciences University, India
ClinicalTrials.gov Identifier:
NCT00890123
First received: April 28, 2009
Last updated: NA
Last verified: April 2009
History: No changes posted
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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. No study with preoperative administration of 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 hip surgery considering the hyperinflammation associated with this type of surgery in elderly patients.
| Condition | Intervention | Phase |
|---|---|---|
|
Hip Surgery |
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 Elderly Patients Undergoing Hip Surgery: 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 levels [ Time Frame: 5 days ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Infectious complications [ Time Frame: 5 days ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 40 |
| Study Start Date: | April 2009 |
| Estimated Study Completion Date: | June 2010 |
| Estimated Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
Will receive IV Omega 3 fatty acids (Omegaven®) for 3 pre operative days
|
Dietary Supplement: Omegaven-IV FO
Will receive IV Omega 3 fatty acids (Omegaven®) for 3 pre operative days
|
|
No Intervention: 2
Will not receive IV Omega 3 fatty acids (Omegaven®) for 3 pre operative days.
|
Eligibility| Ages Eligible for Study: | 60 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Elderly male or female patients undergoing hip surgeries
- Age > 60 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 cyclooxygenase 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
- Participation in any other clinical trial within the last 2 months
Contacts and Locations
No Contacts or Locations Provided
More Information
No publications provided
| Responsible Party: | Dr R Gopinath, NIMS-Hyderabad-India |
| ClinicalTrials.gov Identifier: | NCT00890123 History of Changes |
| Other Study ID Numbers: | Omegaven Hip Surgery |
| Study First Received: | April 28, 2009 |
| Last Updated: | April 28, 2009 |
| Health Authority: | India: Institutional Review Board |
Keywords provided by Nizam's Institute of Medical Sciences University, India:
|
IVOmega 3 FA Inflammation Hip Surgery Inflammatory status Infectious complications |
ClinicalTrials.gov processed this record on May 23, 2013