Preoperative Intravenous Omega 3 Fatty Acids Administration in Elderly Patients Undergoing Hip Surgery

Phase 4

Completed

• Conditions: Hip Surgery
• Interventions: Dietary Supplement: Omegaven-IV FO

• Registration Number: NCT00890123
• Lead Sponsor: 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. 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 hyper-inflammation associated with this type of surgery in elderly patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04
• Study First Submitted: 2009-04-28
• Study First Submitted QC: 2009-04-28
• Study First Posted: 2009-04-29
• Primary Completion: 2010-04
• Study Completion: 2010-12
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-01
• Last Update Posted: 2014-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Elderly male or female patients undergoing hip surgeries
2. Age > 60 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 cyclooxygenase 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. Participation in any other clinical trial within the last 2 months

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Omegaven	Omegaven-IV FO	Patients in this arm will receive IV Omega 3 fatty acids (Omegaven®) for 3 days preoperatively.

Primary Outcome Measures

Name	Time	Method
IL-6, 8, 10, HS-CRP levels	5 days

Secondary Outcome Measures

Name	Time	Method
Infectious complications	5 days

Trial Locations

Locations (1)

Nizam's Institute of Medical Sciences; 🇮🇳 Hyderabad, AP, India