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

NCT03912766 | Completed

• 1 other identifier: MULodz 2/2016
• Study Type: observational
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Benign Prostatic Hyperplasia

Keywords

transurethral prostatectomy; copeptin; hyponatremia; risk prediction

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Transurethral Prostatectomy

male patients undergoing transurethral prostatectomy (TURP) for benign prostatic hyperplasia, routine surgical removal using resectoscope

Diagnostic Test: serum copeptin

Interventions

serum copeptin DIAGNOSTIC_TEST

routine surgical method using resectoscope inserted into the urinary bladder

Transurethral Prostatectomy

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Medical University of Lodz: lead

Study Sites (1)

Department of Nephrology, Hypertension and Kidney Transplantation

Lodz, 90-153, Poland

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum and plasma for lab assessements required by the protocol

MeSH Terms

Conditions

Prostatic Hyperplasia; Diabetes Insipidus; Hyponatremia

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Pituitary Diseases; Endocrine System Diseases; Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Michal Nowicki, MD PhD

  Medical University of Lodz

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2019
• First Posted: April 11, 2019
• Study Start: February 1, 2016
• Primary Completion: January 2, 2017
• Study Completion: March 30, 2018
• Last Updated: April 11, 2019

Record last verified: 2019-04

Locations

PL (1)