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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00890123
Other study ID # NIMS/2008/Omegaven/Surgery/01
Secondary ID
Status Completed
Phase Phase 4
First received April 28, 2009
Last updated October 1, 2014
Start date April 2009
Est. completion date December 2010

Study information

Verified date October 2014
Source Nizam's Institute of Medical Sciences University, India
Contact n/a
Is FDA regulated No
Health authority India: Institutional Review Board
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date December 2010
Est. primary completion date April 2010
Accepts healthy volunteers No
Gender Both
Age group 60 Years to 80 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Omegaven-IV FO
Will receive IV Omega 3 fatty acids (Omegaven®) for 3 pre operative days

Locations

Country Name City State
India Nizam's Institute of Medical Sciences Hyderabad AP

Sponsors (1)

Lead Sponsor Collaborator
Nizam's Institute of Medical Sciences University, India

Country where clinical trial is conducted

India, 

Outcome

Type Measure Description Time frame Safety issue
Primary IL-6, 8, 10, HS-CRP levels 5 days Yes
Secondary Infectious complications 5 days No
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