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CompletedNCT00929461Updated Nov 25, 2009

Impact of Omega-3 Fatty Acids on Lactate

An interventional study of Lipovenoes® 10% and Omegaven®, in Gastric Surgery, sponsored by Ege University. Completed at 1 site in Turkey. Open to participants aged 25 Years to 65 Years. Per ClinicalTrials.gov, last updated 2009-11-25.

Sponsored by Ege University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Ages
25 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Gastric Surgery

Keywords

  • omega-3 fatty acids
  • lactate
  • surgery
  • gastric cancer
  • address the effect of postoperative administration of omega-3 fatty acids on cellular hypoperfusion associated with major gastric surgery.
03

In context

Lead sponsor

Ege University is the lead sponsor of 365 studies on the registry; 46 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years to 65 Years
Sexes eligible
All

Inclusion criteria

  • Patients undergoing major gastric cancer surgery

Exclusion criteria

Exclusion Criteria:

  • None
05

Study design

Phase
Not applicable
Primary purpose
Treatment

Study arms

  • Other
    Omega-3 group

    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®,

  • Other
    Omega 3 + Omega 6 group

    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

  • DrugLipovenoes® 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.

06

Study locations

1 site
  • Ege University General Surgery Dep
    Izmir, 35100, Turkey
07

References and documents

Publications

  • 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.
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 25, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00929461
Lead sponsor
Ege University
First posted
Jun 29, 2009
Last update
Nov 25, 2009

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2009. You cannot join it, but the record below documents what was studied.

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