Clinical trial · Interventional
Hydroxyethyl Starch and Renal Function After Radical Prostatectomy
Effect of Hydroxyethyl Starch on Renal Handling of Sodium and Water, Vasoactive Hormones,Biomarkers and the Circulatory System in Patients Undergoing Radical Prostatectomy
NCT01486563CI-TRIAL-00012096VORAcompletedPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sodium Chloride 9 mg/ml | Drug | — | UNRESOLVED |
| Voluven (Hydroxyethyl starch 130/0,4) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Voluven (Hydroxyethyl starch 130/0,4)
- description
- Patients undergoing radical prostatectomy will receive either fluid therapy with active comparator (Voluven) or placebo (Sodium Chloride)
- interventionNames
- Drug: Voluven (Hydroxyethyl starch 130/0,4)
- type
- PLACEBO_COMPARATOR
- label
- Sodium Chloride 9 mg/ml
- description
- Patients undergoing radical prostatectomy will receive either fluid therapy with active comparator (Voluven) or placebo (Sodium Chloride)
- interventionNames
- Drug: Sodium Chloride 9 mg/ml
Primary outcomes (1)
- measure
- u-NGAL
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDKancir ASP, Johansen JK, Ekeloef NP, Pedersen EB. The effect of 6% hydroxyethyl starch 130/0.4 on renal function, arterial blood pressure, and vasoactive hormones during radical prostatectomy: a randomized controlled trial. Anesth Analg. 2015 Mar;120(3):608-618. doi: 10.1213/ANE.0000000000000596. PMID 25627076