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Hydroxyethyl Starch and Renal Function After Radical Prostatectomy

NCT ID: NCT01486563

Last Updated: 2013-09-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2013-06-30

Brief Summary

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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

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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

Conditions

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Prostate Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Voluven (Hydroxyethyl starch 130/0,4)

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

Group Type ACTIVE_COMPARATOR

Voluven (Hydroxyethyl starch 130/0,4)

Intervention Type DRUG

7,5 ml/kg in the first hour and then 5 ml/kg

Sodium Chloride 9 mg/ml

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

Group Type PLACEBO_COMPARATOR

Sodium Chloride 9 mg/ml

Intervention Type DRUG

7,5 ml/kg in the first hour and then 5 ml/kg

Interventions

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Voluven (Hydroxyethyl starch 130/0,4)

7,5 ml/kg in the first hour and then 5 ml/kg

Intervention Type DRUG

Sodium Chloride 9 mg/ml

7,5 ml/kg in the first hour and then 5 ml/kg

Intervention Type DRUG

Other Intervention Names

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Voluven Venofundin Hydroxyethyl starch Istone saline solution

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Regional Hospital Holstebro

OTHER

Sponsor Role lead

Responsible Party

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Erling Bjerregaard Pedersen

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Anne Sophie P. Kancir, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Holstebro Regional Hospital

Locations

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Medicinsk forskningsafsnit, Regionshospitalet Holstebro

Holstebro, , Denmark

Site Status

Countries

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Denmark

References

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Kancir 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.

Reference Type DERIVED
PMID: 25627076 (View on PubMed)

Other Identifiers

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ASK-2-2011

Identifier Type: -

Identifier Source: org_study_id