Ignite Creation Date:
2025-12-24 @ 12:14 PM
Ignite Modification Date:
2026-01-01 @ 9:43 PM
Study NCT ID:
NCT00929461
Status:
COMPLETED
Last Update Posted:
2009-11-25
First Post:
2009-06-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Omega-3 Fatty Acids on Lactate
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013274', 'term': 'Stomach Neoplasms'}], 'ancestors': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C568345', 'term': 'fish oil triglycerides'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'TREATMENT'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-11', 'lastUpdateSubmitDate': '2009-11-24', 'studyFirstSubmitDate': '2009-06-25', 'studyFirstSubmitQcDate': '2009-06-26', 'lastUpdatePostDateStruct': {'date': '2009-11-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-06-29', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'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.'], 'conditions': ['Gastric Surgery']}, 'referencesModule': {'references': [{'type': 'RESULT', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '25 Years', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing major gastric cancer surgery\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT00929461', 'briefTitle': 'Impact of Omega-3 Fatty Acids on Lactate', 'organization': {'class': 'OTHER', 'fullName': 'Ege University'}, 'officialTitle': 'Do Omega-3 Fatty Acids Have Any Impact On Serum Lactate Levels After Major Gastric Cancer Surgery?', 'orgStudyIdInfo': {'id': 'B.30.2.EGE.0.01.00.00/7EM/458'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Omega-3 group', 'description': "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.", 'interventionNames': ['Drug: Lipovenoes® 10% and Omegaven®,']}, {'type': 'OTHER', 'label': 'Omega 3 + Omega 6 group', 'description': "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.", 'interventionNames': ['Drug: Lipovenoes® 10% and Omegaven®,']}], 'interventions': [{'name': 'Lipovenoes® 10% and Omegaven®,', 'type': 'DRUG', 'description': "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.", 'armGroupLabels': ['Omega 3 + Omega 6 group', 'Omega-3 group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35100', 'city': 'Izmir', 'state': 'İzmir', 'country': 'Turkey (Türkiye)', 'facility': 'Ege University General Surgery Dep', 'geoPoint': {'lat': 38.41273, 'lon': 27.13838}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ege University', 'class': 'OTHER'}}}}