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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03912766
Other study ID # MULodz 2/2016
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 1, 2016
Est. completion date March 30, 2018

Study information

Verified date April 2019
Source Medical Universtity of Lodz
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


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


Recruitment information / eligibility

Status Completed
Enrollment 43
Est. completion date March 30, 2018
Est. primary completion date January 2, 2017
Accepts healthy volunteers No
Gender Male
Age group 40 Years to 80 Years
Eligibility 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 Design


Intervention

Diagnostic Test:
serum copeptin
routine surgical method using resectoscope inserted into the urinary bladder

Locations

Country Name City State
Poland Department of Nephrology, Hypertension and Kidney Transplantation Lódz

Sponsors (1)

Lead Sponsor Collaborator
Medical Universtity of Lodz

Country where clinical trial is conducted

Poland, 

Outcome

Type Measure Description Time frame Safety issue
Primary change of serum sodium after 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
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