PREVENTION OF WORSENING RENAL FUNCTION OF INTRAVENUS ALBUMIN IN HEART FAILURE PATIENTS

Official title

HUMAN ALBUMIN IN HEART FAILURE - DIORASIS TRIAL

Overview

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

• Drug Human 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 A

Primary outcome measures

• Assessment of symptoms [Time frame: From baseline to 72 hours.]
• Change in the serum creatinine level [Time frame: From baseline to 72 hours.]

Secondary outcome measures (5)

• Patient-reported dyspnea [Time frame: From baseline to 72 hours.]
• Changes in body weight [Time frame: From baseline to 72 hours.]
• Length of stay [Time frame: From baseline to discharge.]
• 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.]
• Net fluid loss [Time frame: From baseline to 72 hours]

Eligibility criteria

Inclusion criteria

• 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
• 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

• 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
• pulmonary edema or pulmonary congestion necessitating use of IV vasodilators
• serum creatinine > 3 mg/dL or glomerular filtration rate (GFR) < 30 ml/min

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Prevention

Study locations

Greece · 1 center

• DUThrace Cardiology Department — Alexandroupoli

Identifiers

NCT: NCT06630923 · 6/ 29.2.2016

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗