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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01486550
Other study ID # ASK-1-2011
Secondary ID
Status Terminated
Phase Phase 4
First received December 4, 2011
Last updated October 8, 2014
Start date December 2011
Est. completion date September 2014

Study information

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

Clinical Trial Summary

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.


Description:

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


Recruitment information / eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Voluven (Hydroxyethyl starch 130/0,4)
7,5 ml/kg in the first hour and then 5 ml/kg minimum
Sodium Chloride 9mg/ml
7,5 ml/kg in the first hour and then 5 ml/kg

Locations

Country Name City State
Denmark Medicinck forskningsafsnit, Regionshospitalet Holstebro Holstebro

Sponsors (1)

Lead Sponsor Collaborator
Regional Hospital Holstebro

Country where clinical trial is conducted

Denmark, 

Outcome

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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