Benign Prostatic HyperplasiaNCT03912766
Serum Copeptin as a Predictor of the Risk of Hyponatremia After Transurethral Prostatectomy
An observational study of Benign Prostatic Hyperplasia, run by Medical University of Lodz at 1 site in Poland.
Trial summary
Hyponatremic hypovolemia is a frequent complication of transurethral resection of the prostate gland (TURP). Copeptin has been established as is a surrogate marker of vasopressin and is measured useful for thea clinical assessment of various sodium and water disturbances. Read more about this study
- Who is it for?
- Ages 40 to 80 years, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia
- What is being tested?
- serum copeptin
- How many people
- 43 participants
- Where
- 1 sitePoland
- Study dates
- 1 Feb 2016to 30 Mar 2018
- Phase
- Observational
- 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 40 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: male patients with benign prostatic hyperplasia (BPH) who wre undergoing transurethral resection of the prostate (TURP)
Who may be able to join
- glomerular filtration rate estimated from serum creatinine with CKD-EPI formula (eGFR) >45 ml/min.
Who cannot join
- acute infection
- heart failure (NYHA stage 3 or 4)
- diabetes insipidus
- nephrogenic diabetes insipidus
- other sodium homeostasis abnormalities
- impaired consciousness
- psychogenic polydipsia
- alcohol abuse.
Trial locations and contacts
1 site in 1 country.
Poland1 site
Department of Nephrology, Hypertension and Kidney Transplantation
Lodz, 90-153
About this study
Hyponatremic hypovolemia is a frequent complication of transurethral resection of the prostate gland (TURP). Copeptin has been established as is a surrogate marker of vasopressin and is measured useful for thea clinical assessment of various sodium and water disturbances. The aim of our the study was to assess the utility of serum concentration of copeptin (CPP) and brain natriuretic peptide (NT-proBNP) for the prediction of postoperative alterations of serum sodium concentration. Study population comprised 43 patients with benign prostatic hyperplasia (BPH) undergoing transurethral resection of the prostate gland. In a forward stepwise multiple regression only serum copeptin before the surgery and the duration of TURP significantly explained the variation of sodium concentration for 12 hours from the start of the surgery. Serum NT-proBNP before the surgery did not predict hyponatremia 12 hours after TURP.Conclusion Serum copeptin before TURP surgery but not NT-proBNP may be a clinically useful marker of a decrease of serum sodium after TURP surgery.
Read the detailed description
Introduction.Hyponatremic hypovolemia is a frequent complication of transurethral resection of the prostate gland (TURP). Copeptin has been established as is a surrogate marker of vasopressin and is measured useful for thea clinical assessment of various sodium and water disturbances. The aim of our the study was to assess the utility of serum concentration of copeptin (CPP) and brain natriuretic peptide (NT-proBNP) for the prediction of postoperative alterations of serum sodium concentration.
Methods. Study population comprised 43 patients with benign prostatic hyperplasia (BPH) undergoing transurethral resection of the prostate gland (TURP) Serum sodium and copeptin (CPP) were measured before the procedure and 12 hours after its completion. and sSerum NT-proBNP was assessment at baseline. Total amount of fluids and sodium administered intravenously and to flush the bladder during TURP was calculated in each patient. Receiver operator characteristics (ROC) curve analysis was used to determine the value of of copeptin (CPP) and NT-proBNP for that could prediction of the decrease of serum sodium after TURP
- Conditions
- Benign Prostatic Hyperplasia
- Being tested
- serum copeptin
- Keywords
- transurethral prostatectomy, copeptin, hyponatremia, risk prediction
- Medical subject headings
- Prostatic Hyperplasia, Diabetes Insipidus, Hyponatremia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
serum copeptinDiagnostic test
routine surgical method using resectoscope inserted into the urinary bladder
| Study group | Role | What they receive |
|---|---|---|
| Transurethral Prostatectomy | male patients undergoing transurethral prostatectomy (TURP) for benign prostatic hyperplasia, routine surgical removal using resectoscope Receives: Diagnostic Test: serum copeptin |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of serum sodium after surgery
predictive value of serum copeptin measured before surgery for serum sodium change after the surgery
Measured: change of serum sodium from baseline to 12 hours post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2019
- Study start1 Feb 2016
- Primary completion2 Jan 2017
- Study completion30 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Prostatic HyperplasiaStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Lodz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michal Nowicki, MD PhD, Principal investigator, Medical University of Lodz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03912766
- Sponsor's protocol ID
- MULodz 2/2016
- Status last verified
- Apr 2019
- First submitted
- 5 Apr 2019
- Last updated
- 11 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: whole dataset could be shared if required and justified by research interest
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum Copeptin as a Predictor of the Risk of Hyponatremia After Transurethral Prostatectomy
- ClinicalTrials.gov ID
- NCT03912766
- Acronym / sponsor ID
- MULodz 2/2016
- Conditions
- Benign Prostatic Hyperplasia
- Keywords
- transurethral prostatectomy, copeptin, hyponatremia, risk prediction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Medical University of LodzUniversity, hospital or other
- Study start
- 1 Feb 2016 (actual)
- Primary completion
- 2 Jan 2017 (actual)
- Study completion
- 30 Mar 2018 (actual)
- First posted
- 11 Apr 2019 (actual)
- 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.
Hyponatremic hypovolemia is a frequent complication of transurethral resection of the prostate gland (TURP). Copeptin has been established as is a surrogate marker of vasopressin and is measured useful for thea clinical assessment of various sodium and water disturbances. The aim of our the study was to assess the utility of serum concentration of copeptin (CPP) and brain natriuretic peptide (NT-proBNP) for the prediction of postoperative alterations of serum sodium concentration. Study population comprised 43 patients with benign prostatic hyperplasia (BPH) undergoing transurethral resection of the prostate gland. In a forward stepwise multiple regression only serum copeptin before the surgery and the duration of TURP significantly explained the variation of sodium concentration for 12 hours from the start of the surgery. Serum NT-proBNP before the surgery did not predict hyponatremia 12 hours after TURP.Conclusion Serum copeptin before TURP surgery but not NT-proBNP may be a clinically useful marker of a decrease of serum sodium after TURP surgery.
Detailed description
Introduction.Hyponatremic hypovolemia is a frequent complication of transurethral resection of the prostate gland (TURP). Copeptin has been established as is a surrogate marker of vasopressin and is measured useful for thea clinical assessment of various sodium and water disturbances. The aim of our the study was to assess the utility of serum concentration of copeptin (CPP) and brain natriuretic peptide (NT-proBNP) for the prediction of postoperative alterations of serum sodium concentration.
Methods. Study population comprised 43 patients with benign prostatic hyperplasia (BPH) undergoing transurethral resection of the prostate gland (TURP) Serum sodium and copeptin (CPP) were measured before the procedure and 12 hours after its completion. and sSerum NT-proBNP was assessment at baseline. Total amount of fluids and sodium administered intravenously and to flush the bladder during TURP was calculated in each patient. Receiver operator characteristics (ROC) curve analysis was used to determine the value of of copeptin (CPP) and NT-proBNP for that could prediction of the decrease of serum sodium after TURP
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transurethral Prostatectomy | – | Diagnostic Test: serum copeptinmale patients undergoing transurethral prostatectomy (TURP) for benign prostatic hyperplasia, routine surgical removal using resectoscope |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- male patients with benign prostatic hyperplasia (BPH) who wre undergoing transurethral resection of the prostate (TURP)
Key inclusion criteria (1 listed)
- glomerular filtration rate estimated from serum creatinine with CKD-EPI formula (eGFR) >45 ml/min.
Key exclusion criteria (8 listed)
- acute infection
- heart failure (NYHA stage 3 or 4)
- diabetes insipidus
- nephrogenic diabetes insipidus
- other sodium homeostasis abnormalities
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 |
|---|---|---|
| serum copeptinroutine surgical method using resectoscope inserted into the urinary bladder | Diagnostic test | Transurethral Prostatectomy |
Primary outcome
change of serum sodium after surgery
Time frame: change of serum sodium from baseline to 12 hours post surgery
predictive value of serum copeptin measured before surgery for serum sodium change after the surgery
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 11 Apr 2019.
- Individual participant dataSharing planned: Undecided. whole dataset could be shared if required and justified by research interest
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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.
Michal Nowicki, MD PhD principal investigator
Medical University of Lodz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Benign Prostatic Hyperplasia, run by Medical University of Lodz at 1 site in Poland.
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 1 inclusion and 8 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 11 Apr 2019. 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 Poland. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
change of serum sodium after surgery (time frame: change of serum sodium from baseline to 12 hours post surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Apr 2019.