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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00890123

Enrollment

Registered

2009-04-29

Start date

2009-04-30

Completion date

2010-12-31

Last updated

2014-10-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hip Surgery

Keywords

Omega 3 Fatty Acids, Inflammation, Hip Surgery, Inflammatory status, Infectious complications

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.

Interventions

DIETARY_SUPPLEMENTOmegaven-IV FO

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

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

60 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
IL-6, 8, 10, HS-CRP levels	5 days

Secondary

Measure	Time frame
Infectious complications	5 days

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026