Diuretic AbuseNCT04182854
Use of Diuretics in Maintenance Hemodialysis Patients Undergoing Bioimpedance-guided Fluid Management
A study testing Furosemid hydrochlorothiazide in people with Diuretic Abuse, run by Capital Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diuretic Abuse
- What is being tested?
- Furosemid hydrochlorothiazide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteChina
- Study dates
- 28 Oct 2019to 1 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- maintenance hemodialysis patient
- unrine volume more than 100ml.
Who cannot join
- myocardial infarction;
- unrine volume less than 100ml.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University internation Hospital
Beijing, Beijing Municipality, 102206
Dongliang Zhang, Doctor, 86-010-69006549, zhangdongliang@pkuih.edu.cn
Zhoucang Zhang, Master
About this study
Official title: Use of Diuretics in Maintenance Hemodialysis Patients With Residual Renal Function Undergoing Bioimpedance-guided Fluid Management
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.
Read the 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.
- Conditions
- Diuretic Abuse
- Being tested
- Furosemid hydrochlorothiazide
- Keywords
- furosemide, hydrochlorothiazide, residual renal function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Furosemid hydrochlorothiazideDrug
furosemide 100mg for one month;furosemide 200mg for one month;furosemide 100mg and hydrochlorothiazide 25mg for one month;
| Study group | Role | What they receive |
|---|---|---|
| diuretics | Experimental | Not described Receives: Drug: Furosemid hydrochlorothiazide |
What is being measured
The primary outcome is the main question the study is designed to answer.
urine volume increasing after diuretic use in maintenance hemodialysis patients with residual renal function
Measured: up to 16 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2019
- Study start28 Oct 2019
- Primary completion1 Feb 2020
- Study completion1 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diuretic AbuseStudies of the same condition, open and under way.
- More trials run by Capital Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dongliang Zhang, MD, Peking University International Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04182854
- Sponsor's protocol ID
- YN2017QN15
- Status last verified
- May 2021
- First submitted
- 22 Nov 2019
- Last updated
- 2 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Diuretics in Maintenance Hemodialysis Patients With Residual Renal Function Undergoing Bioimpedance-guided Fluid Management
- ClinicalTrials.gov ID
- NCT04182854
- Acronym / sponsor ID
- YN2017QN15
- Conditions
- Diuretic Abuse
- Keywords
- furosemide, hydrochlorothiazide, residual renal function
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Study start
- 28 Oct 2019 (actual)
- Primary completion
- 1 Feb 2020 (actual)
- Study completion
- 1 Jul 2021 (estimated)
- First posted
- 2 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| diuretics | Experimental | Drug: Furosemid hydrochlorothiazide |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- maintenance hemodialysis patient
- unrine volume more than 100ml.
Key exclusion criteria (2 listed)
- myocardial infarction;
- unrine volume less than 100ml.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Furosemid hydrochlorothiazidefurosemide 100mg for one month;furosemide 200mg for one month;furosemide 100mg and hydrochlorothiazide 25mg for one month; | Drug | diuretics |
Primary outcome
urine volume increasing after diuretic use in maintenance hemodialysis patients with residual renal function
Time frame: up to 16 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2021.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Furosemid hydrochlorothiazide in people with Diuretic Abuse, run by Capital Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yunfei Ding, Master (13521586952, dingyunfei@pkuih.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
urine volume increasing after diuretic use in maintenance hemodialysis patients with residual renal function (time frame: up to 16 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2021.