a failing heart Decompensated heart failure
Conditions
Interventions
Methods: Each patient will receive a pulmonary artery catheter to measure
intracardiac pressures. After informed consent, patients will be randomized
(Figure 3) to IABP (without inotrope, group I) o
Table 2) is not reached, a patient is classified
as clinical *non-responder*by protocol. In these non-responders, a crossover of
the protocol will be performed using the same endpoints. After 48h (o
target >2.5 L/min/m2).
- SvO2 (target >55%)
- Lactate (target 0.5 mL/kg/uur).
If necessary, dobutamine can be added in a dose of 1-10 µg/kg/min, dependent
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: CONGESTIVE HEART FAILURE (FIRST EPISODE (*DE NOVO*) OR WORSENING OF CHRONIC HEART FAILURE) WITH THE FOLLOWING CHARACTERISTICS: - BLOOD PRESSURE Systolic 15 mm Hg; CVP >12 mm Hg; SvO2 200 pg/mL - FLUID BALANCE Neutral or positive despite fluid restriction (1.5L/24h) and administration of high dosages of intravenous diuretics - TOGETHER WITH: Dysfunction of at least 1 other organ (kidney, liver, lactate)
Exclusion criteria
Exclusion criteria: - Significant aortic valve regurgitation - Absent common femoral artery pulsation - Acute myocardial infarction
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Delta SvO2 (T3h minus baseline T0h (=mean of two baseline measurements with interval 15 minutes)). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints: - Cardiac power output at T=24h (absolute and change vs baseline). - NT-proBNP levels at T=48h (absolute and change vs baseline). - Negative fluid balance of at least 1L at T48h. - Sublingual perfused capillary density (=microcirculation) at T=24h. - Contrast-enhanced ultrasound of renal perfusion at T=24h. - Patient Global Assessment: Dyspnea Severity Score or Visual Analogue Scale at T=48h (absolute and change vs baseline). - Escalation of therapy (Table 3). - Duration of hospital stay. - Major adverse cardiac events (MACE, = combined endpoint of escalation of therapy, death, heart failure rehospitalization, TIA/stroke). To assess at 30 days and 3 months. Other study parameters - Initiation of renal replacement therapy. - IABP-related complications (bleeding according to BARC criteria, infection, access site complications according to VARC-2 criteria). - Final result of treatment to be recorded at hospital discharge: Bridge to chronic heart failure with good quality of life, LVAD, heart transplantation, palliative care. | — |
Countries
Netherlands
Outcome results
None listed