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

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ClinicalTrials.gov Identifier: NCT03912766
Recruitment Status : Completed
First Posted : April 11, 2019
Last Update Posted : April 11, 2019
Sponsor:
Information provided by (Responsible Party):
Medical Universtity of Lodz

Brief 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. 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.

Condition or disease Intervention/treatment
Benign Prostatic Hyperplasia Diagnostic Test: serum copeptin

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


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Study Type : Observational
Actual Enrollment : 43 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Serum Copeptin as a Predictor of the Risk of Hyponatremia After Transurethral Prostatectomy
Actual Study Start Date : February 1, 2016
Actual Primary Completion Date : January 2, 2017
Actual Study Completion Date : March 30, 2018

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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


Biospecimen Retention:   Samples Without DNA
serum and plasma for lab assessements required by the protocol


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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
male patients with benign prostatic hyperplasia (BPH) who wre undergoing transurethral resection of the prostate (TURP)
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03912766


Locations
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Poland
Department of Nephrology, Hypertension and Kidney Transplantation
Łódź, Poland, 90-153
Sponsors and Collaborators
Medical Universtity of Lodz
Investigators
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Principal Investigator: Michal Nowicki, MD PhD Medical University of Lodz

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Responsible Party: Medical Universtity of Lodz
ClinicalTrials.gov Identifier: NCT03912766     History of Changes
Other Study ID Numbers: MULodz 2/2016
First Posted: April 11, 2019    Key Record Dates
Last Update Posted: April 11, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: whole dataset could be shared if required and justified by research interest

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Medical Universtity of Lodz:
transurethral prostatectomy
copeptin
hyponatremia
risk prediction
Additional relevant MeSH terms:
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Prostatic Hyperplasia
Diabetes Insipidus
Hyponatremia
Hyperplasia
Pathologic Processes
Prostatic Diseases
Genital Diseases, Male
Water-Electrolyte Imbalance
Metabolic Diseases
Kidney Diseases
Urologic Diseases
Pituitary Diseases
Endocrine System Diseases
Arginine Vasopressin
Hemostatics
Coagulants
Vasoconstrictor Agents
Antidiuretic Agents
Natriuretic Agents
Physiological Effects of Drugs