Prostate CancerPhase 4VORANCT01486563
Hydroxyethyl Starch and Renal Function After Radical Prostatectomy
A Phase 4 study testing Voluven (Hydroxyethyl starch 130/0,4) and Sodium Chloride 9 mg/ml in people with Prostate Cancer, run by Regional Hospital Holstebro at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Voluven (Hydroxyethyl starch 130/0,4) and Sodium Chloride 9 mg/ml
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2012to Jun 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years
- Males
- Indication for radical prostatectomy
Who cannot join
- Blood donation within the last month
- Lack of wish to participate
- eGFR< 15ml/min
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Medicinsk forskningsafsnit, Regionshospitalet Holstebro
Holstebro, 7500
About this study
Official title: Effect of Hydroxyethyl Starch on Renal Handling of Sodium and Water, Vasoactive Hormones,Biomarkers and the Circulatory System in Patients Undergoing Radical Prostatectomy
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.
Read the 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
- Conditions
- Prostate Cancer
- Being tested
- Voluven (Hydroxyethyl starch 130/0,4), Sodium Chloride 9 mg/ml
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Voluven (Hydroxyethyl starch 130/0,4)Drug
Also called Voluven, Venofundin, Hydroxyethyl starch
7,5 ml/kg in the first hour and then 5 ml/kg
Sodium Chloride 9 mg/mlDrug
Also called Istone saline solution
7,5 ml/kg in the first hour and then 5 ml/kg
| Study group | Role | What they receive |
|---|---|---|
| Voluven (Hydroxyethyl starch 130/0,4) | Active comparator | Patients undergoing radical prostatectomy will receive either fluid therapy with active comparator (Voluven) or placebo (Sodium Chloride) Receives: Drug: Voluven (Hydroxyethyl starch 130/0,4) |
| Sodium Chloride 9 mg/ml | Placebo comparator | Patients undergoing radical prostatectomy will receive either fluid therapy with active comparator (Voluven) or placebo (Sodium Chloride) Receives: Drug: Sodium Chloride 9 mg/ml |
What is being measured
The primary outcome is the main question the study is designed to answer.
u-NGAL
The main objective for the trial (only patients undergoing elective radical prostatectomy) is to measure the effect of hydroxyethyl starch on u-NGAL, which is a biomarker of nephrotoxicity
Measured: 2-4 hours
Secondary outcomes (4)
u-Kim 1, u- FABP
Another objective of the trial (only patients undergoing elective radical prostatectomy) is to measure the effect of hydroxyethyl starch on u-Kim1 and u-LFABP, which are also biomarkers of nephrotoxicity
Measured: 2-4 hours
FENa, u-ENaCβ, CH2O, u-AQP2,u-NCC, u-NK2CC
Secondarily to measure the effect of hydroxyethyl starch on the renal tubular transport of sodium and water during elective radical prostatectomy
Measured: 2-4 hours
PRC, p-Ang-II, p -Aldo, p-ANP,P-GDP, p-AVP, p-Endot
Thirdly to measure the effect of hydroxyethyl starch on vasoactive hormones during elective radical prostatectomy
Measured: 2-4 hours
SBP, DBP, heartrate
Fourthly to measure the effect of hydroxyethyl starch on central hemodynamics during elective radical prostatectomy
Measured: 2-4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2011 (estimated)
- Study startJan 2012
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regional Hospital Holstebro
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erling Bjerregaard Pedersen, Regional Hospital Holstebro
- Investigators
- Anne Sophie P. Kancir, MD PhD, Principal investigator, Holstebro Regional Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01486563
- Sponsor's protocol ID
- ASK-2-2011
- Acronym
- VORA
- Status last verified
- Sep 2013
- First submitted
- 4 Dec 2011
- Last updated
- 17 Sep 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 25627076
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Hydroxyethyl Starch on Renal Handling of Sodium and Water, Vasoactive Hormones,Biomarkers and the Circulatory System in Patients Undergoing Radical Prostatectomy
- ClinicalTrials.gov ID
- NCT01486563
- Acronym / sponsor ID
- VORA / ASK-2-2011
- Conditions
- Prostate Cancer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Regional Hospital HolstebroUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 6 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Voluven (Hydroxyethyl starch 130/0,4) | Active comparator | Drug: Voluven (Hydroxyethyl starch 130/0,4)Patients undergoing radical prostatectomy will receive either fluid therapy with active comparator (Voluven) or placebo (Sodium Chloride) |
| Sodium Chloride 9 mg/ml | Placebo comparator | Drug: Sodium Chloride 9 mg/mlPatients undergoing radical prostatectomy will receive either fluid therapy with active comparator (Voluven) or placebo (Sodium Chloride) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age > 18 years
- Males
- Indication for radical prostatectomy
Key exclusion criteria (3 listed)
- Blood donation within the last month
- Lack of wish to participate
- eGFR< 15ml/min
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Voluven (Hydroxyethyl starch 130/0,4)Also: Voluven, Venofundin, Hydroxyethyl starch7,5 ml/kg in the first hour and then 5 ml/kg | Drug | Voluven (Hydroxyethyl starch 130/0,4) |
| Sodium Chloride 9 mg/mlAlso: Istone saline solution7,5 ml/kg in the first hour and then 5 ml/kg | Drug | Sodium Chloride 9 mg/ml |
Primary outcome
u-NGAL
Time frame: 2-4 hours
The main objective for the trial (only patients undergoing elective radical prostatectomy) is to measure the effect of hydroxyethyl starch on u-NGAL, which is a biomarker of nephrotoxicity
4 secondary outcomes
u-Kim 1, u- FABP
Time frame: 2-4 hours
FENa, u-ENaCβ, CH2O, u-AQP2,u-NCC, u-NK2CC
Time frame: 2-4 hours
PRC, p-Ang-II, p -Aldo, p-ANP,P-GDP, p-AVP, p-Endot
Time frame: 2-4 hours
SBP, DBP, heartrate
Time frame: 2-4 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2013.
- Derived from this study: PubMed 25627076Kancir 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne Sophie P. Kancir, MD PhD principal investigator
Holstebro Regional Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Voluven (Hydroxyethyl starch 130/0,4) and Sodium Chloride 9 mg/ml in people with Prostate Cancer, run by Regional Hospital Holstebro at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
u-NGAL (time frame: 2-4 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01486563, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2013.