Metabolic and Clinical Effects of Hyperchloremia During H... | NCT07655830

Studies
Metabolic and Clinical Effects of Hyperchloremia During HoLEP Surgery.

NCT07655830

Sponsor

Ankara City Hospital Bilkent

Status

Not yet recruiting

Last Update Posted

Jun 18, 2026Actual

Enrollment

45Estimated

Phase

Not provided

Conditions

HoLEP (Holmium Laser Enucleation of Prostate)
Hyperchloremia
Perioperative Management

Interventions

HoLEP surgery

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2026

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 4, 2026Estimated

Primary Completion Date

Aug 30, 2026Estimated

Completion Date

Sep 30, 2026Estimated

First Submitted Date

Jun 5, 2026

First Submission Date that Met QC Criteria

Jun 13, 2026

First Posted Date

Jun 18, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 13, 2026

Last Update Posted Date

Jun 18, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study aims to evaluate the changes between preoperative and postoperative serum chloride levels in patients undergoing HoLEP surgery and to investigate the metabolic and clinical effects of this change. The study is observational, and no additional interventions will be performed.

Detailed Description

Although isotonic irrigation fluids used in HoLEP surgery reduce the risk of hyponatremia associated with TUR syndrome, high-volume fluid absorption may lead to hyperchloremia and subsequent metabolic acidosis. This prospective, observational, single-center study, conducted at Ankara Bilkent City Hospital, aims to identify early markers of this condition to optimize perioperative management.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

45Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients undergoing elective HoLEP surgery.			Procedure: HoLEP surgery

Interventions

Name	Type	Description	Arm Group Labels	Other Names
HoLEP surgery	Procedure	All parameters are part of routine clinical practice; no additional examinations are required	Patients undergoing elective HoLEP surgery.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in serum chloride level		Perioperative

Secondary Outcomes

Measure	Description	Time Frame
irrigation volume		Perioperative
Arter blood gas		Perioperative

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients scheduled for elective HoLEP surgery.
Patients providing written informed consent

Exclusion Criteria:

Preoperative metabolic acidosis.
Advanced renal failure.
Emergency surgery.
Missing data.

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients scheduled for elective HoLEP surgery.

Sampling Method

Probability Sample

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided