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Effect of combination diuretics in patients with acutely decompensated Heart Failure and Acute Kidney Injury: a randomized controlled clinical trial

Effect of combined diuretic therapy in patients with acutely decompensated Heart Failure and Acute Kidney Injury: a randomized controlled clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-2xjfkk8
Enrollment
Unknown
Registered
2024-06-20
Start date
2024-08-01
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Kidney Injury

Interventions

This is a clinical trial, controlled, randomized, non-blind, single-center, parallel group study, designed in accordance with the Consolidated Standards of Reporting Trials (CONSORT). Patients of both

Sponsors

Faculdade de Medicina de Botucatu da Universidade Estadual Paulista
Lead Sponsor
Faculdade de Medicina de Botucatu da Universidade Estadual Paulista
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients of both sexes will be included in the study; older than 18 years; with a previous clinical diagnosis of heart failure; in daily home use of oral loop diuretic (furosemide = 80 mg and =240 mg); with clinical signs of volume overload (edema, ascites, pleural effusion or pulmonary congestion); Acute Kidney Injury KDIGO 1 and 2 admitted to the Clinical Emergency Room at the Referred Emergency Room of Hospital das Clinicas de Botucatu

Exclusion criteria

Exclusion criteria: Exclusion criteria will be use of vasoactive drugs, systolic blood pressure less than 90 mmHg; stage 5 chronic kidney disease or KDIGO 3 Acute Kidney Injury on admission; presence of hemodynamically significant arrhythmias; hypokalemia and hyponatremia on admission; inability to comply with planned study procedures or refusal to participate

Design outcomes

Primary

MeasureTime frame
Evaluate the improvement in signs of congestion using the scale used in the study by Mullens et al., 2022, which scores from 0 to 10 according to the presence of signs of volume overload, considering the presence of edema, residual pleural effusion and ascites.;Assess changes in body weight, measured using a scale, from the start of the study until 72 hours after randomization.;Evaluate dyspnea reported by the patient from the beginning of the study until 72 hours after randomization verified by the visual analogue scale (VAS), where patients will be asked to evaluate the perception of dyspnea by marking a 10 cm horizontal line, with the upper part of the scale as “I can’t breathe” and the bottom as “I can breathe normally”. We will score the patients' markings on a scale of 0 to 100mm, measuring the distance in millimeters from the bottom of the line, similarly to what was done in the study by Trulls et al., 2023.

Secondary

MeasureTime frame
Assess renal function through laboratory tests for plasma creatinine, urea and electrolytes from the beginning of hospitalization until hospital discharge.;Assess the total number of days the patient was hospitalized.;Evaluate the number of new hospitalizations of the patient due to heart failure during 3 months of follow-up by monitoring the electronic medical record.;Assess all-cause mortality during 3 months of follow-up using the electronic medical record.

Countries

Brazil

Contacts

Public ContactLuis Franco Ramirez

Faculdade de Medicina de Botucatu da Universidade Estadual Paulista

drfranco_r@hotmail.com+55(014)99606-0059

Outcome results

None listed

Source: REBEC (via WHO ICTRP)