PREVENTION OF WORSENING RENAL FUNCTION OF INTRAVENUS ALBUMIN IN HEART FAILURE PATIENTS
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-95
SponsorDemocritus University of Thrace
About this trial
Patients hospitalized for acute decompensation of CHF are usually complicated by worsening renal function (WRF) which leads to diuretic resistance and inadequate decongestion as well as poor prognosis. WRF has been attributed to a reflex renal vasoconstriction elicited by intravascular volume depletion during brisk diuresis. The investigators hypothesize that CHF patients with hepatic dysfunction are more prone to WRF due to poor albumin production. This sub-group of CHF patients may benefit more (increased diuretic efficacy and protected against worsening renal function) by the use of IV loop diuretics in combination with an intravascular volume expander such as IV Human Albumin.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
age over 18 yrs
acute decompensation of CHF
evidence of hepatic dysfunction by laboratory biochemical measurements or imaging (liver ultrasonography)
history of CHF with previous use of an oral loop diuretic
Disqualifiers
hemodynamic collapse (at least one of the following: systolic blood pressure (BP) < 90 mmHg, or BP drop by >= 40 mmHg for >= 15 min, with end-organ hypoperfusion; need for inotropes (except of digoxin); need for cardiopulmonary resuscitation).
hepatic dysfunction of other than cardiac etiology
severe anemia (Hb<8 g/dL)
uncontrolled hypertension or hypertensive emergency/urgency
Trial design
Design model
Parallel
Treatments tested in this trial
Human albumin
DrugExperimental intervention (Group A): Continuous slow IV infusion of Human Albumin, based on diuresis-adjusted dosing, not later than 30 minutes after randomisation and not later than 2 hours after admission. Concomitant continuous slow IV infusion of diuretics (furosemide) based on body weight- and diuresis-adjusted dosing. Control intervention (Group B): Continuous slow IV infusion of diuretics (furosemide), based on body weight - and diuresis-adjusted dosing. Experimental intervention (Human Albumin) is off-label treatment for patients with acute decompensation of CHF in Greece. Control intervention (IV diuretic therapy) is on-label treatment for acute decompensation CHF in Greece.
Treatment groups
250 Participants
are divided into 2 treatment groupsGroup A: IV Human Albumin + IV FurosemideActive comparator 1 intervention
Group B: IV Furosemide alonePlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Assessment of symptoms
Patient's global assessment of symptoms, measured with the use of a visual-analogue scale (VAS) and quantified as the area under the curve (AUC) of serial assessments.
Time frame
From baseline to 72 hours.2
Change in the serum creatinine level
Change in the serum creatinine level
Time frame
From baseline to 72 hours.Secondary outcomes
1
Patient-reported dyspnea
Patient-reported dyspnea (as assessed with the use of a VAS and quantified as the AUC of serial assessments)
Time frame
From baseline to 72 hours.2
Changes in body weight
Changes in body weight
Time frame
From baseline to 72 hours.3
Length of stay
Length of stay
Time frame
From baseline to discharge.4
The composite of death, rehospitalization, escalation in treatment or an emergency room visit within 180 days.
The composite of death, rehospitalization, escalation in treatment or an emergency room visit within 180 days.
Time frame
From baseline to 180 days from discharge.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov