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Recruiting NCT07271420

Blood Pressure Control With Thiazide Diuretics in Peritoneal Dialysis Patients

Phase IV Interventional Hypertension Peritoneal Dialysis End Stage Kidney Disease (ESRD)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Hydrochlorothiazide 25mg once per day.
Who it may be relevant to
Registry conditions: Hypertension, Peritoneal Dialysis, End Stage Kidney Disease (ESRD). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Hong Kong
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

To evaluate the blood pressure lowering effects of thiazide diuretics in patients on peritoneal dialysis

Detailed description

This prospective, single-center treatment-withdrawal crossover study enrolled 10 patients on chronic peritoneal dialysis (PD) and uncontrolled hypertension (SBP \>140 mmHg and/or DBP \>90 mmHg).

Following written informed consent, participants entered the treatment arm, receiving oral hydrochlorothiazide once daily on top of their standard of treatment for 90 days. This was followed by a 14-day washout period, after which participants entered a 90-day control period.

Interventions

  • Drug Hydrochlorothiazide 25mg once per day
    Thiazides diuretics

Primary outcome measures

  • Change in systolic and diastolic blood pressure [Time frame: 90 days]
Secondary outcome measures (3)
  • Changes in body weight [Time frame: 90 days]
  • Changes in body composition measured by bio impedance spectroscopy [Time frame: 90 days]
  • Change in urinary fractional excretion of sodium [Time frame: 90 days]

Eligibility criteria

Inclusion criteria

  • Patients on chronic peritoneal dialysis, with uncontrolled hypertension (SBP >140 mmHg and/or DBP >90 mmHg)

Exclusion criteria

  • Patients with a life expectancy of less than 3 months, planned conversion to hemodialysis, or scheduled kidney transplantation within 3 months

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Crossover
Masking
Open label
Primary purpose
Treatment

Study locations

Hong Kong · 1 center
  • Prince of Wales Hospital. The Chinese University of Hong Kong — Hong Kong

Publications

  • Agarwal R, Sinha AD, Cramer AE, Balmes-Fenwick M, Dickinson JH, Ouyang F, Tu W. Chlorthalidone for Hypertension in Advanced Chronic Kidney Disease. N Engl J Med. 2021 Dec 30;385(27):2507-2519. doi: 10.1056/NEJMoa2110730. Epub 2021 Nov 5. PMID 34739197
  • Ali S, Navaneethan SD, Virani SS, Gregg LP. Revisiting diuretic choice in chronic kidney disease. Curr Opin Nephrol Hypertens. 2022 Sep 1;31(5):406-413. doi: 10.1097/MNH.0000000000000814. Epub 2022 Jul 11. PMID 35894274
  • An J, Kurella Tamura M, Odden MC, Ni L, Thomas IC, Montez-Rath ME, Sim JJ. Prevalence of Apparent Treatment-Resistant Hypertension in Chronic Kidney Disease in Two Large US Health Care Systems. Clin J Am Soc Nephrol. 2022 Oct;17(10):1457-1466. doi: 10.2215/CJN.04110422. Epub 2022 Sep 9. PMID 36400564
  • Chan GC, Ng JK, Chow KM, Cheng PM, Law MC, Leung CB, Li PK, Szeto CC. Polypharmacy Predicts Onset and Transition of Frailty, Malnutrition, and Adverse Outcomes in Peritoneal Dialysis Patient. J Nutr Health Aging. 2022;26(12):1054-1060. doi: 10.1007/s12603-022-1859-8. PMID 36519768

Identifiers

NCT: NCT07271420 · CREC2019.580

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗