Cardiogenic shock, heart failure
Conditions
Interventions
Intra-aortic balloon pump vs inotropic therapy
Sponsors
Erasmus MC
Eligibility
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 mmHg; CVP >12 mmHg; 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# PCWP, pulmonary capillary wedge pressure; CVP, central venous pressure. * Bolus dosage (equal to) 80 mg intravenous furosemide followed by total intravenous dosage equal to total daily loop diuretic dose in furosemide equivalents and (if necessary) doubled, for at least 12h. # Lung: extra oxygen supplementation, kidney: creatinine clearance <50 mL/min, liver enzymes ¡Ý2x upper limit of normal, or lactate levels ¡Ý2.0 mmol/L.
Exclusion criteria
Exclusion criteria: - Significant aortic valve regurgitation. - Absent common femoral artery pulsation. - Acute myocardial infarction <7 days before inclusion.
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 |
|---|---|
| - 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. - Patient Global Assessment: Dyspnea Severity Score or Visual Analogue Scale at T=48h (absolute and change vs baseline). - Escalation of therapy. - 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. | — |
Contacts
Public ContactC.A. den Uil
s-Gravendijkwal 230
Outcome results
None listed