Restrictive Versus Liberal Fluid Intake in Acute Decompensated Heart Failure
ConditionAcute Heart Failure (AHF)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorGødstrup Hospital
About this trial
The aim of this clinical trial is to learn whether a thirst-driven, liberal fluid-intake strategy is comparable to a fluid-restriction strategy in patients hospitalized for acute decompensated heart failure (ADHF). The study will also assess the safety of the intervention and its effects on thirst and quality of life.
Patients hospitalized with ADHF will be asked to follow either a thirst-driven fluid-intake strategy or a fluid-restriction strategy during their hospital stay and for one month after discharge.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age >18 years
≥1 documented symptom of new or worsening heart failure (dyspnea, fatigue, decreased exercise tolerance, or symptom of end-organ hypoperfusion).
Treatment with ≥40 mg IV furosemide (or equivalent)
Enrolment within 24 hours of admission
Disqualifiers
Requirement at admission for ICU-level care, or IV inotropic/vasopressor therapy for ADHF.
Na+ <125 mmol/L or Na+ >145 mmol/L.
End-stage chronic kidney disease on chronic dialysis or eGFR <15 mL/min/1.73 m2
Any condition which would make participation unsafe or substantially affect protocol adherence, as judged by investigator.
Trial design
Design model
Parallel
Treatments tested in this trial
Fluid restriction strategy
BehavioralFluid restriction of 1.5 L/day
Thirst-driven, liberal fluid intake
BehavioralLiberal fluid intake driven by thirst without restrictions
Treatment groups
420 Participants
are divided into 2 treatment groupsGroup A: Thirst-driven, liberal fluid intakeExperimental treatment 1 intervention
Group B: Fluid restrictionActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Time to clinical stability
Time from randomization to clinical stability. Clinical stability is defined as: 1. Off IV loop diuretics for ≥ 24 hours without need for reinitiation of IV diuretics. 2. No evidence of pulmonary congestion, defined as both: i) No new or worsening dyspnea at rest compared with status at admission ii) Clear lung auscultation or clinically improved, or normal lung and/or vena cava ultrasound without evidence of congestion. 3. No new or worsening peripheral edema compared with status at admission.
Time frame
From enrollment to 1 month follow-upSecondary outcomes
1
Thirst Distress
Thirst Distress Scale for patients with Heart Failure (TDS-HF). Scores range from 8 to 40. Higher scores indicate greater thirst-related distress
Time frame
From enrollment to 1 month follow up2
Patient-perceived Quality of Life
Kansas City Cardiomyopathy Questionnaire (KCCQ). Scores range from 0 to 100, with higher scores indicating better health status.
Time frame
From enrollment to 1 month follow up3
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Number of occurrences during hospitalization of clinical worsening (escalation of HF therapy, such as vasopressor/inotrope initiation, ICU transfer, dialysis, reinitiation of IV diuretics), electrolyte disturbances, worsening renal function, or in-hospital death, and similarly after one month including HF hospitalization
Time frame
From enrollment to 1 month follow upSponsors and contacts
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Source ClinicalTrials.gov