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Completed

NCT Number: NCT00890838

Preoperative Intravenous Omega 3 Fatty Acids Administration in Valvular Surgery Patients

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.

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Key information

Conditions

Valvular Surgery Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

NIzam's Institute of Medical Sciences

Hyderabad, Andhra Pradesh, India

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Omegaven-IV FO

Dietary Supplement

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

Primary outcomes

  1. IL-6, 8, 10, HS-CRP

    Time frame: 5 days

Secondary outcomes

  1. Infectious complications

    Time frame: 5 days

Sponsors and collaborators

Lead sponsor

Nizam's Institute of Medical Sciences University, India

Other

Registry information

Official study title

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

Acronym: IVFO-Valvular

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Apr 30, 2009
Registry last updated
Oct 2, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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