Hydroxyethyl Starch and Renal Function After Radical Prostatectomy (VORA)

Regional Hospital Holstebro

Status and phase: Completed; Phase 4

Conditions: Prostate Cancer

Treatments: Drug: Voluven (Hydroxyethyl starch 130/0,4); Drug: Sodium Chloride 9 mg/ml

Study type: Interventional

Funder types: Other

Identifiers

NCT01486563

ASK-2-2011

Details and patient eligibility

About

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.

Full 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

Enrollment: 40 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age > 18 years
• Males
• Indication for radical prostatectomy

Exclusion criteria

• Blood donation within the last month
• Lack of wish to participate
• eGFR< 15ml/min

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 2 patient groups, including a placebo group

Voluven (Hydroxyethyl starch 130/0,4)

Active Comparator group

Description:

Patients undergoing radical prostatectomy will receive either fluid therapy with active comparator (Voluven) or placebo (Sodium Chloride)

Treatment:

Drug: Voluven (Hydroxyethyl starch 130/0,4)

Sodium Chloride 9 mg/ml

Placebo Comparator group

Description:

Patients undergoing radical prostatectomy will receive either fluid therapy with active comparator (Voluven) or placebo (Sodium Chloride)

Treatment:

Drug: Sodium Chloride 9 mg/ml