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

Study Overview
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Brief Summary
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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.

Official Title
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Preoperative Intravenous Omega 3 Fatty Acids Administration in Elderly Patients Undergoing Hip Surgery: A Prospective, Randomized, Open-label, Comparative Clinical Trial

Conditions
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Hip Surgery

Intervention / Treatment
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* Dietary Supplement: Omegaven-IV FO


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Omegaven<br>Patients in this arm will receive IV Omega 3 fatty acids (Omegaven®) for 3 days preoperatively. | Dietary Supplement: Omegaven-IV FO<br>* Will receive IV Omega 3 fatty acids (Omegaven®) for 3 pre operative days<br>|
| No Intervention: Without Omegaven<br>Patients will not receive IV Omega 3 fatty acids | |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infectious complications |  | 5 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Omega 3 Fatty Acids, Inflammation, Hip Surgery, Inflammatory status, Infectious complications