Albumin; Double, Diuretics Drug Reactions, Heart Failure; With Decompensation
Conditions
Keywords
Human Albumin, Furosemide, Heart Failure
Brief summary
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.
Detailed description
Acute decompensation of chronic heart failure (CHF) warranting hospital admission, defined as diagnosed on the basis of the presence of at least one symptom (dyspnea, orthopnea, paroxysmal nocturnal dyspnea, weight gain, worsening functional class or edema) and one sign (rales, peripheral edema, ascites, increased jugular vein pressure, hepatomegaly, third heart sound gallop or pulmonary vascular congestion on chest radiography) of heart failure plus laboratory or imaging evidence of hepatic dysfunction at randomization
Interventions
DRUGHuman albumin
Experimental 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.
Sponsors
Democritus University of Thrace
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 95 Years
Healthy volunteers
No
Inclusion criteria
1. age over 18 yrs 2. acute decompensation of CHF 3. evidence of hepatic dysfunction by laboratory biochemical measurements or imaging (liver ultrasonography) 4. history of CHF with previous use of an oral loop diuretic 5. anticipated need for IV diuretic therapy for at least 72 hours There is no pre-specified inclusion criterion with respect to ejection fraction
Exclusion criteria
1. 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). 2. hepatic dysfunction of other than cardiac etiology 3. severe anemia (Hb\<8 g/dL) 4. uncontrolled hypertension or hypertensive emergency/urgency 5. pulmonary edema or pulmonary congestion necessitating use of IV vasodilators 6. serum creatinine \> 3 mg/dL or glomerular filtration rate (GFR) \< 30 ml/min
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of symptoms | From baseline to 72 hours. | 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. |
| Change in the serum creatinine level | From baseline to 72 hours. | Change in the serum creatinine level |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient-reported dyspnea | From baseline to 72 hours. | Patient-reported dyspnea (as assessed with the use of a VAS and quantified as the AUC of serial assessments) |
| Changes in body weight | From baseline to 72 hours. | Changes in body weight |
| Net fluid loss | From baseline to 72 hours | Net fluid loss |
| The composite of death, rehospitalization, escalation in treatment or an emergency room visit within 180 days. | From baseline to 180 days from discharge. | The composite of death, rehospitalization, escalation in treatment or an emergency room visit within 180 days. |
| Length of stay | From baseline to discharge. | Length of stay |
Countries
Greece
Contacts
Primary ContactMARIOS-VASILEIOS A KOUTROULOS
Backup ContactANARGYROS TSALGKIDIS
Outcome results
None listed