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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00929461
Other study ID # B.30.2.EGE.0.01.00.00/7EM/458
Secondary ID
Status Completed
Phase N/A
First received June 25, 2009
Last updated November 24, 2009

Study information

Verified date November 2009
Source Ege University
Contact n/a
Is FDA regulated No
Health authority Turkey: Ethics Committee
Study type Interventional

Clinical Trial Summary

Pre- and intra-operative nutritional support in patient undergoing major surgery results in decreased morbidity and mortality. Studies investigating the role of omega-3 fatty acids in these patients are increasing. Some are focused on perfusion at the cellular level. This study was undertaken to address the effect of postoperative administration of omega-3 fatty acids on cellular hypoperfusion associated with major gastric surgery.


Recruitment information / eligibility

Status Completed
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender Both
Age group 25 Years to 65 Years
Eligibility Inclusion Criteria:

- Patients undergoing major gastric cancer surgery

Exclusion Criteria:

Study Design

Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Lipovenoes® 10% and Omegaven®,
All patients received TPN for 5 days postoperatively, according to a standard protocol: 3 g/kg BW glucose (5% Dextrose in Ringer's Lactate, Biosel, Istanbul), 1.2 g/kg BW amino acids (Aminosteril 10%, Fresenius-Kabi) and 0.8 g/kg BW omega-6 fatty acids (Lipovenoes® 10%, Fresenius-Kabi) were provided to both groups through an indwelling central venous catheter. In the omega-3 group, the lipid content of TPN was replaced partially by omega-3 fatty acids (Omegaven®, Fresenius-Kabi) up to 0.2 g/kg BW per day.

Locations

Country Name City State
Turkey Ege University General Surgery Dep Izmir

Sponsors (1)

Lead Sponsor Collaborator
Ege University

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

16. McNelis J, Marini CP, Jurkiewicz A, et al. Prolonged lactate clearance is associated with increased mortality in the surgical intensive care unit. Am J Surg 2001; 182: 481-5. 7. Smith I, Kumar P, Molloy S, et al. Base excess and lactate as prognostic

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