Preoperative Intravenous Omega 3 Fatty Acids Administration in Valvular Surgery Patients

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. To the investigators' knowledge, no study with preoperative administration of intravenous (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 valvular surgery considering the hyperinflammation associated with this type of surgery in elderly patients.

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

Conditions
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Valvular Surgery, Inflammation

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: Adult male or female patients undergoing valvular surgeries Age 18-50 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 cycloxygenase 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 Pregnant or nursing women Participation in any other clinical trial within the last 2 months

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 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>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>will not receive IV Omega 3 fatty acids (Omegaven®) for 3 days preoperativel | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IL-6, 8, 10, HS-CRP |  | 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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IVFO, Inflammation, Valvular surgery, Inflammatory status, Infectious complications