Serum Copeptin as a Predictor of the Risk of Hyponatremia After Transurethral Prostatectomy

April 10, 2019 updated by: Medical University of Lodz
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

43

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Łódź, Poland, 90-153
        • Department of Nephrology, Hypertension and Kidney Transplantation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Probability Sample

Study Population

male patients with benign prostatic hyperplasia (BPH) who wre undergoing transurethral resection of the prostate (TURP)

Description

Inclusion Criteria:

- glomerular filtration rate estimated from serum creatinine with CKD-EPI formula (eGFR) >45 ml/min.

Exclusion Criteria:

  • acute infection
  • heart failure (NYHA stage 3 or 4)
  • diabetes insipidus
  • nephrogenic diabetes insipidus
  • other sodium homeostasis abnormalities
  • impaired consciousness
  • psychogenic polydipsia
  • alcohol abuse.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Transurethral Prostatectomy
male patients undergoing transurethral prostatectomy (TURP) for benign prostatic hyperplasia, routine surgical removal using resectoscope
Diagnostic test: serum copeptin
routine surgical method using resectoscope inserted into the urinary bladder

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
change of serum sodium from baseline to 12 hours post surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Lodz

Investigators

  • Principal Investigator: Michal Nowicki, MD PhD, Medical University of Lodz

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2016

Primary Completion (Actual)

January 2, 2017

Study Completion (Actual)

March 30, 2018

Study Registration Dates

First Submitted

April 5, 2019

First Submitted That Met QC Criteria

April 10, 2019

First Posted (Actual)

April 11, 2019

Study Record Updates

Last Update Posted (Actual)

April 11, 2019

Last Update Submitted That Met QC Criteria

April 10, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MULodz 2/2016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

whole dataset could be shared if required and justified by research interest

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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