Ignite Creation Date:
2025-12-24 @ 4:35 PM
Ignite Modification Date:
2025-12-24 @ 4:35 PM
Study NCT ID:
NCT03912766
Status:
COMPLETED
Last Update Posted:
2019-04-11
First Post:
2019-04-05
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Serum Copeptin as a Predictor of the Risk of Hyponatremia After Transurethral Prostatectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011470', 'term': 'Prostatic Hyperplasia'}, {'id': 'D003919', 'term': 'Diabetes Insipidus'}, {'id': 'D007010', 'term': 'Hyponatremia'}], 'ancestors': [{'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'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': 'D010900', 'term': 'Pituitary Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D014883', 'term': 'Water-Electrolyte Imbalance'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'serum and plasma for lab assessements required by the protocol'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 43}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2018-03-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-10', 'studyFirstSubmitDate': '2019-04-05', 'studyFirstSubmitQcDate': '2019-04-10', 'lastUpdatePostDateStruct': {'date': '2019-04-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-01-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change of serum sodium after surgery', 'timeFrame': 'change of serum sodium from baseline to 12 hours post surgery', 'description': 'predictive value of serum copeptin measured before surgery for serum sodium change after the surgery'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['transurethral prostatectomy', 'copeptin', 'hyponatremia', 'risk prediction'], 'conditions': ['Benign Prostatic Hyperplasia']}, 'descriptionModule': {'briefSummary': 'Hyponatremic hypovolemia is a frequent complication of transurethral resection of the prostate gland (TURP). Copeptin has been established as is a surrogate marker of vasopressin and is measured useful for thea clinical assessment of various sodium and water disturbances. The aim of our the study was to assess the utility of serum concentration of copeptin (CPP) and brain natriuretic peptide (NT-proBNP) for the prediction of postoperative alterations of serum sodium concentration. Study population comprised 43 patients with benign prostatic hyperplasia (BPH) undergoing transurethral resection of the prostate gland. In a forward stepwise multiple regression only serum copeptin before the surgery and the duration of TURP significantly explained the variation of sodium concentration for 12 hours from the start of the surgery. Serum NT-proBNP before the surgery did not predict hyponatremia 12 hours after TURP.Conclusion Serum copeptin before TURP surgery but not NT-proBNP may be a clinically useful marker of a decrease of serum sodium after TURP surgery.', 'detailedDescription': 'Introduction.Hyponatremic hypovolemia is a frequent complication of transurethral resection of the prostate gland (TURP). Copeptin has been established as is a surrogate marker of vasopressin and is measured useful for thea clinical assessment of various sodium and water disturbances. The aim of our the study was to assess the utility of serum concentration of copeptin (CPP) and brain natriuretic peptide (NT-proBNP) for the prediction of postoperative alterations of serum sodium concentration.\n\nMethods. Study population comprised 43 patients with benign prostatic hyperplasia (BPH) undergoing transurethral resection of the prostate gland (TURP) Serum sodium and copeptin (CPP) were measured before the procedure and 12 hours after its completion. and sSerum NT-proBNP was assessment at baseline. Total amount of fluids and sodium administered intravenously and to flush the bladder during TURP was calculated in each patient. Receiver operator characteristics (ROC) curve analysis was used to determine the value of of copeptin (CPP) and NT-proBNP for that could prediction of the decrease of serum sodium after TURP'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'male patients with benign prostatic hyperplasia (BPH) who wre undergoing transurethral resection of the prostate (TURP)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- glomerular filtration rate estimated from serum creatinine with CKD-EPI formula (eGFR) \\>45 ml/min.\n\nExclusion Criteria:\n\n* acute infection\n* heart failure (NYHA stage 3 or 4)\n* diabetes insipidus\n* nephrogenic diabetes insipidus\n* other sodium homeostasis abnormalities\n* impaired consciousness\n* psychogenic polydipsia\n* alcohol abuse.'}, 'identificationModule': {'nctId': 'NCT03912766', 'briefTitle': 'Serum Copeptin as a Predictor of the Risk of Hyponatremia After Transurethral Prostatectomy', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Lodz'}, 'officialTitle': 'Serum Copeptin as a Predictor of the Risk of Hyponatremia After Transurethral Prostatectomy', 'orgStudyIdInfo': {'id': 'MULodz 2/2016'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Transurethral Prostatectomy', 'description': 'male patients undergoing transurethral prostatectomy (TURP) for benign prostatic hyperplasia, routine surgical removal using resectoscope', 'interventionNames': ['Diagnostic Test: serum copeptin']}], 'interventions': [{'name': 'serum copeptin', 'type': 'DIAGNOSTIC_TEST', 'description': 'routine surgical method using resectoscope inserted into the urinary bladder', 'armGroupLabels': ['Transurethral Prostatectomy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90-153', 'city': 'Lodz', 'country': 'Poland', 'facility': 'Department of Nephrology, Hypertension and Kidney Transplantation', 'geoPoint': {'lat': 51.77058, 'lon': 19.47395}}], 'overallOfficials': [{'name': 'Michal Nowicki, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University of Lodz'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'whole dataset could be shared if required and justified by research interest'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Lodz', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}