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
Qualifiers
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
Treatments tested in this trial
- Human albumin
Treatment groups
250 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov