Kidney Cancer Clinical Trial
— VONEOfficial title:
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
Verified date | October 2014 |
Source | Regional Hospital Holstebro |
Contact | n/a |
Is FDA regulated | No |
Health authority | Denmark: National Board of Health |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 14 |
Est. completion date | September 2014 |
Est. primary completion date | September 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Age > 18 years - Males and females - Indication for laparoscopic nephrectomy Exclusion Criteria: - Blood donation within the last month - Lack of wish to participate - eGFR< 15ml/min - Pregnancy or breast feeding |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Denmark | Medicinck forskningsafsnit, Regionshospitalet Holstebro | Holstebro |
Lead Sponsor | Collaborator |
---|---|
Regional Hospital Holstebro |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | u-NGAL | 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 | 2-4 hours | Yes |
Secondary | u-Kim1 and u-LFABP | 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 | 2-4 hours | Yes |
Secondary | FENa, u-ENaCß, CH2O, u-AQP2,u-NCC, u-NK2CC | Secondarily to measure the effect of hydroxyethyl starch on the renal tubular transport of sodium and water during elective laparoscopic nephrectomy | 2-4 hours | No |
Secondary | PRC, p-Ang-II, p -Aldo, p-ANP,P-GDP, p-AVP, p-Endothelin | Thirdly to measure the effect of hydroxyethyl starch on vasoactive hormones during elective laparoscopic nephrectomy | 2-4 hours | No |
Secondary | SBP, DBP, heartrate | Fourthly measure the effect of hydroxyethyl starch on central hemodynamics during elective laparoscopic nephrectomy | 2-4 hours | No |
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