NCT00929461

Brief 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
completed

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Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 25, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 29, 2009

Completed
Last Updated

November 25, 2009

Status Verified

November 1, 2009

First QC Date

June 25, 2009

Last Update Submit

November 24, 2009

Conditions

Keywords

omega-3 fatty acidslactatesurgerygastric canceraddress the effect of postoperative administration of omega-3 fatty acids on cellular hypoperfusion associated with major gastric surgery.

Study Arms (2)

Omega-3 group

OTHER

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.

Drug: Lipovenoes® 10% and Omegaven®,

Omega 3 + Omega 6 group

OTHER

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.

Drug: Lipovenoes® 10% and Omegaven®,

Interventions

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.

Omega 3 + Omega 6 groupOmega-3 group

Eligibility Criteria

Age25 Years - 65 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing major gastric cancer surgery

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ege University General Surgery Dep

Izmir, İzmir, 35100, Turkey (Türkiye)

Location

Related 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 indicators for patients admitted to intensive care. Intensive Care Med 2001; 27: 74-83. 8. Husain FA, Martin MJ, Mullenix PS, et al. Serum lactate and base deficit as predictors of mortality and morbidity. Am J Surg 2003; 185: 485-91. 9. Skalski M, Goto M, Ravindranath T, et al. Omega-3 polyunsaturated fatty acid enriched diet attenuates stress induced lactacidemia in 10-day-old rats. Pediatr Int 2001; 43: 409-16. 11. Pscheidl EM, Wan JM, Blackburn GL, et al. Influence of omega-3 fatty acids on splanchnic blood flow and lactate metabolism in an endotoxemic rat model. Metabolism 1992; 41: 698-705. 22. Farolan LR, Goto M, Myers TF, et al. Perinatal nutrition enriched with omega-3 polyunsaturated fatty acids attenuates endotoxic shock in newborn rats. Shock 1996; 6: 263-6. 23. Pomposelli JJ, Flores EA, Blackburn GL, et al. Diets enriched with N-3 fatty acids ameliorate lactic acidosis by improving endotoxin-induced tissue hypoperfusion in guinea pigs. Ann Surg 1991; 213:166-76.

    RESULT

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

fish oil triglycerides

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Design

Study Type
interventional
Phase
not applicable
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 25, 2009

First Posted

June 29, 2009

Last Updated

November 25, 2009

Record last verified: 2009-11

Locations