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:
Regional Hospital Holstebro
Organization:
Study Overview
Official 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
Status:
TERMINATED
Status Verified Date:
2014-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Lack of patient enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VONE
Brief 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.
Detailed 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
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: