Ignite Creation Date:
2025-12-24 @ 3:18 PM
Ignite Modification Date:
2026-03-09 @ 2:28 AM
Study NCT ID:
NCT02881892
Status:
COMPLETED
Last Update Posted:
2016-08-29
First Post:
2016-08-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Iplasma IL6, Procalcitonin and VEGF and Dialysate Level in CAPD Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077740', 'term': 'Procalcitonin'}, {'id': 'D042461', 'term': 'Vascular Endothelial Growth Factor A'}], 'ancestors': [{'id': 'D002116', 'term': 'Calcitonin'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011498', 'term': 'Protein Precursors'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D042442', 'term': 'Vascular Endothelial Growth Factors'}, {'id': 'D042501', 'term': 'Angiogenic Proteins'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-08-26', 'studyFirstSubmitDate': '2016-08-18', 'studyFirstSubmitQcDate': '2016-08-26', 'lastUpdatePostDateStruct': {'date': '2016-08-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-08-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'plasma level of VEGF, IL-6 and procalcitonin with the PSTR and dialysis adequacy in CAPD patients', 'timeFrame': '2 years', 'description': 'measure in pg/ml'}], 'secondaryOutcomes': [{'measure': 'Cytokines in diabetic and non-diabetic group', 'timeFrame': '2 years', 'description': 'All cytokines in plasma and blood'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['CAPD', 'Peritoneal solute transport rate', 'Dialysis adequacy'], 'conditions': ['Chronic Kidney Disease']}, 'referencesModule': {'references': [{'pmid': '20061317', 'type': 'BACKGROUND', 'citation': 'Oh KH, Jung JY, Yoon MO, Song A, Lee H, Ro H, Hwang YH, Kim DK, Margetts P, Ahn C. Intra-peritoneal interleukin-6 system is a potent determinant of the baseline peritoneal solute transport in incident peritoneal dialysis patients. Nephrol Dial Transplant. 2010 May;25(5):1639-46. doi: 10.1093/ndt/gfp670. Epub 2010 Jan 8.'}, {'pmid': '16178476', 'type': 'BACKGROUND', 'citation': 'Alscher DM, Mettang T. Procalcitonin in peritoneal dialysis--a useful marker of inflammation? Perit Dial Int. 2005 Sep-Oct;25(5):441-4. No abstract available.'}, {'pmid': '15683455', 'type': 'BACKGROUND', 'citation': 'Herget-Rosenthal S, Klein T, Marggraf G, Hirsch T, Jakob HG, Philipp T, Kribben A. Modulation and source of procalcitonin in reduced renal function and renal replacement therapy. Scand J Immunol. 2005 Feb;61(2):180-6. doi: 10.1111/j.0300-9475.2005.01545.x.'}, {'pmid': '16623432', 'type': 'BACKGROUND', 'citation': 'Guz G, Colak B, Hizel K, Reis KA, Erten Y, Bali M, Sindel S. Procalcitonin and conventional markers of inflammation in peritoneal dialysis patients and peritonitis. Perit Dial Int. 2006 Mar-Apr;26(2):240-8.'}, {'pmid': '12147798', 'type': 'RESULT', 'citation': 'Pecoits-Filho R, Araujo MR, Lindholm B, Stenvinkel P, Abensur H, Romao JE Jr, Marcondes M, De Oliveira AH, Noronha IL. Plasma and dialysate IL-6 and VEGF concentrations are associated with high peritoneal solute transport rate. Nephrol Dial Transplant. 2002 Aug;17(8):1480-6. doi: 10.1093/ndt/17.8.1480.'}]}, 'descriptionModule': {'briefSummary': 'The aim of study was to evaluated the correlation between plasma levels, dialysate appearance rate of VEGF, inflammatory cytokines (IL- 6, procalcitonin) and PSTR, dialysis adequacy in CAPD patients.', 'detailedDescription': 'This cross -sectional study measured IL-6, procalcitonin and VEGF level in plasma and overnight effluent. PSTR of small solutes was evaluated by standard peritoneal equilibration test (standard PET). Weekly Kt/V and creatinine clearance (CCr ) were evaluated in all patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'CAPD patients age more than 18 years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Stable CAPD patients without previous history of peritonitis\n\nExclusion Criteria:\n\n* HIV\n* Other infections, tuberculosis or on immunosuppressive drugs,\n* Autoimmune disease,\n* Cancer\n* Diagnosis of permanent ultrafiltration failure .'}, 'identificationModule': {'nctId': 'NCT02881892', 'briefTitle': 'Iplasma IL6, Procalcitonin and VEGF and Dialysate Level in CAPD Patients', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Bangkok Metropolitan Administration Medical College and Vajira Hospital'}, 'officialTitle': 'Interleukin-6, Procalcitonin and Vascular Endothelial Growth Factor in Plasma and Dialysate Correlate With Peritoneal Solute Transport and Dialysis Adequacy in CAPD Patients', 'orgStudyIdInfo': {'id': '041/57'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Measure plasma and dialysate level of IL-6, procalcitonin and VEGF', 'type': 'OTHER', 'description': 'correlation between plasma levels, dialysate appearance rate of VEGF, inflammatory cytokines (IL- 6, procalcitonin) and PSTR, dialysis adequacy in CAPD patients.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '10300', 'city': 'Bangkok', 'country': 'Thailand', 'facility': 'Renal Unit, BMA Medical College and Vajira Hospital', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}], 'overallOfficials': [{'name': 'Thananda Trakarnvniach, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Medicine,Vajira Hospital,Navamindradhiraj University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bangkok Metropolitan Administration Medical College and Vajira Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Thananda Trakarnvanich', 'investigatorAffiliation': 'Bangkok Metropolitan Administration Medical College and Vajira Hospital'}}}}