Acute Heart Failure, Acute Kidney Injury
Conditions
Keywords
Acute heart failure, Diuretic resistance, Sequential nephron blockade, Diuretic combination
Brief summary
This study aims to demonstrate the efficacy of sequential nephron blockade by adding hydrochlorothiazide or spironolactone on intravenous furosemide compared to intravenous furosemide alone in the treatments of volume overload in patients with acute heart failure who have diuretic resistance from furosemide stress test.
Detailed description
This study is a randomised, double-blinded, double-dummy, placebo-controlled study to demonstrate the efficacy of oral hydrochlorothiazide or spironolactone in combination with intravenous furosemide compared to intravenous furosemide in combination with placebo. Dosage of intravenous furosemide will be adjusted according to pre-defined protocol. The primary outcome is urine volume during 72 hours after randomisation.
Interventions
DRUGSpironolactone or hydrochlorothiazide
Patients will be received spironolactone or hydrochlorothiazide in combination with intravenous furosemide according to patients' serum potassium levels. If serum potassium levels ≤4 mEq/L, patients will be received spironolactone 100 mg every 12 hour for 72 hours. If serum potassium levels \>4 mEq/L, patients will be received hydrochlorothiazide 50 mg every 12 hour for 72 hours.
DRUGPlacebo
Patients will be received spironolactone placebo or hydrochlorothiazide placebo in combination with intravenous furosemide according to patients' serum potassium levels. If serum potassium levels ≤4 mEq/L, patients will be received spironolactone placebo every 12 hour for 72 hours. If serum potassium levels \>4 mEq/L, patients will be received hydrochlorothiazide placebo every 12 hour for 72 hours.
Sponsors
Chiang Mai University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥18 years * Diagnosis of acute heart failure which is defined by 2 of the 3 following features: ≥2+ leg edema, jugular venous pressure \>10 cm from physical examination or central venous pressure \>10 mmHg, and bilateral pulmonary edema or bilateral pleural effusion from chest radiography * Patients consent to participate into the study
Exclusion criteria
* Patients who receive furosemide ≥500 mg/day or hydrochlorothiazide ≥100 mg/day or spironolactone ≥100 mg/day or tolvaptan of any doses * Patients who have systolic blood pressure \<100 mmHg or who need vasoactive drugs inotropic agents (except dobutamine) * Patients with intravascular volume depletion from clinical evaluation * Patients with chronic kidney disease stage 5 (estimated glomerular filtration rate \<15 ml/min/1.73 m2) or patients who receive maintenance dialysis * Patients who require renal replacement therapy at the time of admission * Patients whom diagnosed hypertrophic obstructive cardiomyopathy, severe valvular stenosis or complex congenital heart disease * Patients with sepsis or systemic infection * Pregnant women * Patients who have history of furosemide, spironolactone or hydrochlorothiazide allergy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Urine volume | 72 hours | Total urine volume after randomisation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Body weight | 72 hours after randomisation | Changes of patient's body weight |
| Length of hospital admission | During hospital admission period | Number of days that patients need to stay in the hospital |
| Furosemide dose | 72 hours after randomisation | Total dosage of intravenous furosemide |
| Urine volume | 24 and 48 hours | Total urine volume after randomization |
| Number of participants with adverse events | During hospital admission | All adverse events during hospital admission |
| Dyspnea score assessed by visual analogue scale | At randomization, and 6, 12, 24, 48 and 72 hours after randomization | The scale is between 0 and 100. The higher scale represents lower level of dyspnea |
| Levels of B-type atrial natriuretic peptide (BNP) | 72 hours and 7 days after randomisation | levels of pro-BNP |
Countries
Thailand
Contacts
Primary ContactKajohnsak Noppakun, MD
Backup ContactTiranun Suriya, RN
Outcome results
None listed