The aim of this randomized trial is to appraise the impact of IABP in the treatment of early stages of cardiogenic shock, irrespective of etiology. Findings of this randomized trial may enhance clinical decision making regarding the use of MCS in…
ID
Source
Brief title
Condition
- Heart failures
- Cardiac therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint of the trial is a composite of 1) all-cause mortality; 2)
escalation to invasive mechanical ventilation; 3) escalation of MCS (including
institution of IABP support in the standard of care-arm, or escalation to
continuous flow or extracorporeal MCS); 4) acute kidney injury and 5) stroke or
transient ischemic attack, at 30 days.
Secondary outcome
Secondary outcomes include at 1 year 1) all-cause mortality and 2) unplanned
hospital re-admission for cardiovascular causes.
The following secondary trial endpoints will also be investigated throughout
the trial (at 30-day follow-up, if not specified otherwise):
- The individual determinants of the composite primary outcome.
- Treatment escalation (see chapter 8 of the IABP ON-TIME protocol, version
2.0).
- Deterioration of cardiogenic shock.
- Vascular complications following randomization to the IABP-arm.
- Major bleeding complications following randomization to the IABP-arm.
- De novo Acute Coronary Syndrome (ACS) (i.e. type 1 Myocardial Infarction)
both at 30-days and 1-year follow-up.
- Cardiopulmonary resuscitation or defibrillation.
- The development of Systemic Inflammatory Response Syndrome (SIRS), sepsis or
severe sepsis within 96 hours after randomization.
Background summary
The scientific underpinning for the use of mechanical circulatory support (MCS)
in early cardiogenic shock, especially for the intra-aortic balloon pump
(IABP), is scarce and insufficiently clarified for different etiologies of
cardiogenic shock. Previous randomized trials limited the inclusion criteria to
patients with ischemic cardiogenic shock while observational research suggested
favorable effects of timely adoption of IABP in patients with deteriorating
myocardial function through ischemic or non-ischemic causes. Early stage of
cardiogenic shock is defined by relative hypotension without hypoperfusion, or
hypoperfusion still responsive to therapy (Society for Cardiovascular
Angiography and Interventions, SCAI, stage B and C, respectively). A tightening
of global guidelines with respect to the clinical adoption of IABP overshadowed
the potential beneficial effects for specific patient categories within the
total spectrum of cardiogenic shock. Patients currently presenting with early
stages of cardiogenic shock caused by ischemic or non-ischemic etiology are
hypothetically undertreated due to an assumed lack of clinical benefit of IABP
in general.
Study objective
The aim of this randomized trial is to appraise the impact of IABP in the
treatment of early stages of cardiogenic shock, irrespective of etiology.
Findings of this randomized trial may enhance clinical decision making
regarding the use of MCS in specific subsets of patients in early stages of
cardiogenic shock.
Study design
Open-label, multicenter, investigator-initiated, randomized controlled trial.
Intervention
Patients enrolled in this trial will be 1:1 randomized to IABP support or
standard of care (i.e. inotropes and/or vasopressors but no IABP insertion).
Patients will be stratified for ACS/non-ischemic etiology and stage B/stage C
cardiogenic shock following stratification according to center.
Study burden and risks
The risk profile attributable to trial participation (moderate, in Dutch
'matig') is acceptable given the reported low complication rate directly
attributable to IABP insertion (according to earlier research). If randomized
to the IABP-arm, an IABP will be inserted after transfemoral arterial access
(the patient is prescribed bedrest afterwards). Apart from this, trial
participation does not involve any specific treatment, test or rule of conduct
(e.g. during follow-up). Findings of this randomized trial will attribute to
future patient selection for MCS within the full spectrum of cardiogenic shock
as well as to verify and to strengthen current clinical guidelines. The trial
may shed further light to treatment differences for patients in different
(cardiogenic) shock stages.
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Listed location countries
Age
Inclusion criteria
- At least 18 years of age.
- Society for Cardiovascular Angiography and Interventions (SCAI) stage B or C
cardiogenic shock. For definitions, please see chapter 4 of the IABP ON-TIME
protocol (version 2.0).
- No more than 1 inotropic agent has been administered and the maximum dose of
noradrenaline/norepinephrine has not exceeded 0.2 µg/kg/min at the time of
randomization to reach mean arterial pressure >65 mmHg.
Exclusion criteria
- Patient in cardiogenic shock, not fulfilling the definition for SCAI stage B
or C. For definitions, please see chapter 4 of the IABP ON-TIME protocol
(version 2.0).
- Administration of >=2 inotropic or vasopressive agents at the time of
randomization.
- Administration of noradrenaline/norepinephrine exceeding 0.2 µg/kg/min at the
time of randomization.
- Suspected or known mechanical complication contributing to cardiogenic shock,
e.g. ventricular septal defect or papillary muscle rupture.
- Cardiogenic shock developing within 72 hours of a surgical procedure (i.e.
low cardiac output with an inability to wean cardiopulmonary bypass).
- Inability to provide informed consent. Of note: patients admitted in
cardiogenic shock who required cardiopulmonary resuscitation earlier, but are
conscious at the time of hospital admission, are eligible for study
participation.
- Known or suspected insufficiency of the aortic valve with at least moderate
aortic regurgitation.
- Known or suspected peripheral arterial disease preventing safe insertion of
IABP.
- Known or suspected thoracic or abdominal aortic disease (including aortic
dissection or aortic aneurysm) precluding safe insertion and use of IABP.
- Suspicion of sepsis or septic shock (including septic cardiomyopathy).
- Pregnancy.
- Predicted life expectancy <6 months because of concomitant disease.
- Concurrent participation in a clinical trial with competing endpoints.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| Other | De studie wordt momenteel geregistreerd op clinicaltrials.gov: het referentienummer is op dit moment nog niet beschikbaar. |
| CCMO | NL85563.078.24 |