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

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

Study Overview

• Status: Completed
• Conditions: Hip Surgery
• Intervention / Treatment: Dietary supplement: Omegaven-IV FO

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 4

Contacts and Locations

Study Locations

• India
  • AP
    • Hyderabad, AP, India
      • Nizam's Institute of Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Omegaven; Patients in this arm 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; Patients will not receive IV Omega 3 fatty acids

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
IL-6, 8, 10, HS-CRP levels	5 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Infectious complications	5 days

Collaborators and Investigators

• Sponsor: Nizam's Institute of Medical Sciences University, India
• Investigators: Principal Investigator: Dr R Gopinath, Professor and Head, Department of ANesthesia and critical care

Study record dates

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 28, 2009
• First Posted (Estimate): April 29, 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

• Keywords: Inflammation; Infectious complications; Hip Surgery; Omega 3 Fatty Acids; Inflammatory status
• Other Study ID Numbers: NIMS/2008/Omegaven/Surgery/01