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

Nizam's Institute of Medical Sciences University, India

Status and phase: Completed; Phase 4

Conditions: Hip Surgery

Treatments: Dietary Supplement: Omegaven-IV FO

Study type: Interventional

Funder types: Other

Identifiers

NCT00890123

NIMS/2008/Omegaven/Surgery/01

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 60 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Omegaven

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Omegaven-IV FO

Without Omegaven

No Intervention group

Description:

Patients will not receive IV Omega 3 fatty acids