Impact of Omega-3 Fatty Acids on Lactate

• Sponsor: Ege University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00929461
• Collaborator: (none)
• Location: 1
• Arms: 2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Gastric Surgery	Drug: Lipovenoes® 10% and Omegaven®,	N/A

Study Design

• Study Type: Interventional
• Primary Purpose: Treatment
• Official Title: Do Omega-3 Fatty Acids Have Any Impact On Serum Lactate Levels After Major Gastric Cancer Surgery?

Arms and Interventions

Arm	Intervention/Treatment
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®,; 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.
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®,; 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.

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

• Ages Eligible for Study: 25 Years to 65 Years
• Sexes Eligible for Study: All

Inclusion Criteria:

• Patients undergoing major gastric cancer surgery

Exclusion Criteria:

• None

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ege University General Surgery Dep	Izmir		Turkey	35100

Sponsors and Collaborators

• Ege University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00929461
• Other Study ID Numbers: B.30.2.EGE.0.01.00.00/7EM/458
• First Posted: Jun 29, 2009
• Last Update Posted: Nov 25, 2009
• Last Verified: Nov 1, 2009

• Keywords provided by , ,: 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.

Study Results

No Results Posted as of Nov 25, 2009