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

NCT00890123 | Completed Phase 4

• 1 other identifier: NIMS/2008/Omegaven/Surgery/01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Hip Surgery

Keywords

Omega 3 Fatty Acids; Inflammation; Hip Surgery; Inflammatory status; Infectious complications

Outcome Measures

Primary Outcomes (1)

• IL-6, 8, 10, HS-CRP levels

  5 days

Secondary Outcomes (1)

• Infectious complications

  5 days

Study Arms (2)

Omegaven

ACTIVE COMPARATOR

Patients in this arm will receive IV Omega 3 fatty acids (Omegaven®) for 3 days preoperatively.

Dietary Supplement: Omegaven-IV FO

Without Omegaven

NO INTERVENTION

Patients will not receive IV Omega 3 fatty acids

Interventions

Omegaven-IV FO DIETARY_SUPPLEMENT

Will receive IV Omega 3 fatty acids (Omegaven®) for 3 pre operative days

Omegaven

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Elderly male or female patients undergoing hip surgeries
• Age \> 60 years
• The patients who give written informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Nizam's Institute of Medical Sciences University, India: lead

Study Sites (1)

Nizam's Institute of Medical Sciences

Hyderabad, Andhra Pradesh, India

Location

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Dr R Gopinath

  Professor and Head, Department of Anesthesia and critical care

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 28, 2009
• First Posted: April 29, 2009
• Study Start: April 1, 2009
• Primary Completion: April 1, 2010
• Study Completion: December 1, 2010
• Last Updated: October 2, 2014

Record last verified: 2014-10

Locations

IN (1)