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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00890123
Recruitment Status : Completed
First Posted : April 29, 2009
Last Update Posted : October 2, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Hip Surgery Dietary Supplement: Omegaven-IV FO Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Preoperative Intravenous Omega 3 Fatty Acids Administration in Elderly Patients Undergoing Hip Surgery: A Prospective, Randomized, Open-label, Comparative Clinical Trial
Study Start Date : April 2009
Primary Completion Date : April 2010
Study Completion Date : December 2010

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U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Omegaven
Patients in this arm will receive IV Omega 3 fatty acids (Omegaven®) for 3 days preoperatively.
Dietary Supplement: Omegaven-IV FO
Will receive IV Omega 3 fatty acids (Omegaven®) for 3 pre operative days
No Intervention: Without Omegaven
Patients will not receive IV Omega 3 fatty acids


Outcome Measures

Primary Outcome Measures :
  1. IL-6, 8, 10, HS-CRP levels [ Time Frame: 5 days ]

Secondary Outcome Measures :
  1. Infectious complications [ Time Frame: 5 days ]

Eligibility Criteria

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Ages Eligible for Study:   60 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00890123


Locations
India
Nizam's Institute of Medical Sciences
Hyderabad, AP, India
Sponsors and Collaborators
Nizam's Institute of Medical Sciences University, India
Investigators
Principal Investigator: Dr R Gopinath Professor and Head, Department of Anesthesia and critical care
More Information

Responsible Party: Dr. R. Gopinath, Professor, Nizam's Institute of Medical Sciences University, India
ClinicalTrials.gov Identifier: NCT00890123     History of Changes
Other Study ID Numbers: NIMS/2008/Omegaven/Surgery/01
First Posted: April 29, 2009    Key Record Dates
Last Update Posted: October 2, 2014
Last Verified: October 2014

Keywords provided by Dr. R. Gopinath, Nizam's Institute of Medical Sciences University, India:
Omega 3 Fatty Acids
Inflammation
Hip Surgery
Inflammatory status
Infectious complications