Know Cancer

or
forgot password

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


Phase 4
18 Years
N/A
Open (Enrolling)
Both
Kidney Cancer

Thank you

Trial Information

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


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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

u-NGAL

Outcome 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

Outcome Time Frame:

2-4 hours

Safety Issue:

Yes

Principal Investigator

Anne Sophie P. Kancir, MD PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Regional Hospital Holstebro

Authority:

Denmark: National Board of Health

Study ID:

ASK-1-2011

NCT ID:

NCT01486550

Start Date:

December 2011

Completion Date:

November 2014

Related Keywords:

  • Kidney Cancer
  • Carcinoma, Renal Cell
  • Kidney Neoplasms

Name

Location