Use of Diuretics in Maintenance Hemodialysis Patients Und... | NCT04182854

Studies
Use of Diuretics in Maintenance Hemodialysis Patients Undergoing Bioimpedance-guided Fluid Management

NCT04182854

Sponsor

Capital Medical University

Status

Unknown status

Last Update Posted

Jun 2, 2021Actual

Enrollment

46Estimated

Phase

Not Applicable

Conditions

Diuretic Abuse

Interventions

Furosemid hydrochlorothiazide

Countries

China

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

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 28, 2019Actual

Primary Completion Date

Feb 1, 2020Actual

Completion Date

Jul 1, 2021Estimated

First Submitted Date

Nov 22, 2019

First Submission Date that Met QC Criteria

Nov 29, 2019

First Posted Date

Dec 2, 2019Actual

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

May 31, 2021

Last Update Posted Date

Jun 2, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dongliang Zhang, MD, professor, Peking University International HospitalPrincipal Investigator

Lead Sponsor

Capital Medical UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Background.The objective of the present study is to verify whether using diuretics will improve either blood pressure or fluid overload in maintenance hemodialysis patients with residual diuresis kidney function.

Detailed Description

Methods.46 maintenance hemodialysis patients will be given three stages of diuretic intervention: 100mg furosemide every day for 1 month, 200mg furosemide every day for 1 month, and 100mg furosemide combined with 25mg hydrochlorothiazide every day for 1 month. The 24-hour urine volume, 24-hour urine sodium, 24-hour urine potassium, blood pressure, OH(overhydration) and dry weight will be collected. OH will be measured by bioelectrical impedance.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

46Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
diuretics	Experimental		Drug: Furosemid hydrochlorothiazide

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Furosemid hydrochlorothiazide	Drug	furosemide 100mg for one month;furosemide 200mg for one month;furosemide 100mg and hydrochlorothiazide 25mg for one month;	diuretics

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
urine volume increasing after diuretic use in maintenance hemodialysis patients with residual renal function		up to 16 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

maintenance hemodialysis patient
unrine volume more than 100ml.

Exclusion Criteria:

myocardial infarction;
unrine volume less than 100ml.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yunfei Ding, Master	Contact	13521586952		dingyunfei@pkuih.edu.cn
zhoucang Zhang, Master	Contact	17710230157		zhangzhoucang@pkuih.edu.cn

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Peking University internation Hospital	Recruiting	Beijing	Beijing Municipality	102206	China

Type	Date	Date Unknown
Release	Jul 25, 2021
Reset	Aug 16, 2021

Submission Tracking

Estimated Results First Submitted Date

Jul 25, 2021

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Jul 25, 2021			Aug 16, 2021