Ignite Creation Date:
2025-12-24 @ 5:09 PM
Ignite Modification Date:
2025-12-27 @ 3:15 AM
Study NCT ID:
NCT01486550
Status:
TERMINATED
Last Update Posted:
2014-10-09
First Post:
2011-12-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hydroxyethyl Starch and Renal Function After Laparoscopic Nephrectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007680', 'term': 'Kidney Neoplasms'}], 'ancestors': [{'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C485123', 'term': 'HES 130-0.4'}, {'id': 'D006895', 'term': 'Hydroxyethyl Starch Derivatives'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D013213', 'term': 'Starch'}, {'id': 'D004040', 'term': 'Dietary Carbohydrates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D005936', 'term': 'Glucans'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'whyStopped': 'Lack of patient enrollment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2011-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-10', 'completionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-10-08', 'studyFirstSubmitDate': '2011-12-04', 'studyFirstSubmitQcDate': '2011-12-05', 'lastUpdatePostDateStruct': {'date': '2014-10-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-12-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'u-NGAL', 'timeFrame': '2-4 hours', 'description': 'The main objective for the trial(only patients undergoing elective laparoscopic nephrectomy) is to measure the effect of hydroxyethyl starch on u-NGAL, which is a biomarker of nephrotoxicity'}], 'secondaryOutcomes': [{'measure': 'u-Kim1 and u-LFABP', 'timeFrame': '2-4 hours', 'description': 'Another objective for the trial(only patients undergoing elective laparoscopic nephrectomy) is to measure the effect of hydroxyethyl starch on u-Kim1 and u-LFAPB, which are also biomarkers of nephrotoxicity'}, {'measure': 'FENa, u-ENaCĪ², CH2O, u-AQP2,u-NCC, u-NK2CC', 'timeFrame': '2-4 hours', 'description': 'Secondarily to measure the effect of hydroxyethyl starch on the renal tubular transport of sodium and water during elective laparoscopic nephrectomy'}, {'measure': 'PRC, p-Ang-II, p -Aldo, p-ANP,P-GDP, p-AVP, p-Endothelin', 'timeFrame': '2-4 hours', 'description': 'Thirdly to measure the effect of hydroxyethyl starch on vasoactive hormones during elective laparoscopic nephrectomy'}, {'measure': 'SBP, DBP, heartrate', 'timeFrame': '2-4 hours', 'description': 'Fourthly measure the effect of hydroxyethyl starch on central hemodynamics during elective laparoscopic nephrectomy'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Kidney Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this project is to investigate if hydroxyethyl starch (HES) is potential nephrotoxic and examine the effects on the circulation and kidneys during administration of HES during surgery.', 'detailedDescription': "Hydroxyethyl starch (HES) is widely used in hospitals to maintain circulation in critically ill patients. In recent years studies have raised suspicion that HES is nephrotoxic. So far acute kidney injury has been diagnosed based on creatinine measurements, but new technology allows for earlier diagnosis using measurements of biomarkers in urine. The purpose of this project is to investigate HES's potential toxicity and effects on the circulation and kidneys using measurements of biomarkers specific for toxicity and for the sodium/water balance in the urine and by measurements of vasoactive hormones in the blood after administration of HES 130/0.4"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> 18 years\n* Males and females\n* Indication for laparoscopic nephrectomy\n\nExclusion Criteria:\n\n* Blood donation within the last month\n* Lack of wish to participate\n* eGFR\\< 15ml/min\n* Pregnancy or breast feeding'}, 'identificationModule': {'nctId': 'NCT01486550', 'acronym': 'VONE', 'briefTitle': 'Hydroxyethyl Starch and Renal Function After Laparoscopic Nephrectomy', 'organization': {'class': 'OTHER', 'fullName': 'Regional Hospital Holstebro'}, 'officialTitle': 'Effect of Hydroxyethyl Starch on Renal Handling of Salt and Water, Blood Pressure-regulating Hormones, Proteins and Circulatory System of Patients Undergoing Kidney Removal by Keyhole Surgery', 'orgStudyIdInfo': {'id': 'ASK-1-2011'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Voluven (Hydroxyethyl starch 130/0,4)', 'description': 'Patients undergoing laparoscopic nephrectomy will receive either fluid therapy with active comparator (Voluven) or placebo (Sodium Chloride)', 'interventionNames': ['Drug: Voluven (Hydroxyethyl starch 130/0,4)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Sodium Chloride 9mg/ml', 'description': 'Patients undergoing laparoscopic nephrectomy will receive either fluid therapy with active comparator (Voluven) or placebo (Sodium Chloride)', 'interventionNames': ['Drug: Sodium Chloride 9mg/ml']}], 'interventions': [{'name': 'Voluven (Hydroxyethyl starch 130/0,4)', 'type': 'DRUG', 'otherNames': ['Voluven', 'Hydroxyethyl starch', 'Venofundin'], 'description': '7,5 ml/kg in the first hour and then 5 ml/kg minimum', 'armGroupLabels': ['Voluven (Hydroxyethyl starch 130/0,4)']}, {'name': 'Sodium Chloride 9mg/ml', 'type': 'DRUG', 'otherNames': ['Isotone saline solution'], 'description': '7,5 ml/kg in the first hour and then 5 ml/kg', 'armGroupLabels': ['Sodium Chloride 9mg/ml']}]}, 'contactsLocationsModule': {'locations': [{'zip': '7500', 'city': 'Holstebro', 'country': 'Denmark', 'facility': 'Medicinck forskningsafsnit, Regionshospitalet Holstebro', 'geoPoint': {'lat': 56.36009, 'lon': 8.61607}}], 'overallOfficials': [{'name': 'Anne Sophie P. Kancir, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Regional Hospital Holstebro'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Regional Hospital Holstebro', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Erling Bjerregaard Pedersen', 'investigatorAffiliation': 'Regional Hospital Holstebro'}}}}