Skip to main content
MedPathMedPath Home
Clinical Trials/NL-OMON56763
NL-OMON56763
Not Yet Recruiting
N/A

Clinical Effects of Intra-aortic Balloon Support in Early Acute Coronary Syndrome and non-Acute Coronary Syndrome related Cardiogenic Shock: a Multicenter Randomized Controlled Trial - IABP ON-TIME

Erasmus MC, Universitair Medisch Centrum Rotterdam0 sites250 target enrollmentTBD
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditions(non-) ischemic cardiogenic shockHeart failure1001928010007593

Overview

Phase
N/A
Intervention
Not specified
Conditions
(non-) ischemic cardiogenic shock
Sponsor
Erasmus MC, Universitair Medisch Centrum Rotterdam
Enrollment
250
Status
Not Yet Recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
last year
Study Type
Interventional

Investigators

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Not specified

Similar Trials

Not Yet Recruiting
N/A
Clinical Effects of Intra-aortic Balloon Support in Early Acute Coronary Syndrome and Non-Acute Coronary Syndrome Related Cardiogenic ShockCardiogenic Shock
NCT06414187Erasmus Medical Center400
Completed
Phase 4
Efficacy and Safety of intra-aortic balloon occlusion: observational studyhemorrhagic shock, elective surgery with high risk of bleeding
JPRN-UMIN000015722Chiba University Graduate School of Medicine100
Recruiting
N/A
Prophylactic intra-aortic balloon counterpulsation in high-risk cardiac surgery: An inception cohort studyHigh-risk cardiac surgeryIschaemic heart diseaseCardiovascular - Coronary heart diseaseSurgery - Surgical techniques
ACTRN12613000293763Australia and New Zealand Cardiothoracic Surgery cardiac surgery database program250
Not Yet Recruiting
N/A
Evaluation of a temporary pump in patients with decompensated heart failureCardiogenic shock, heart failure
NL-OMON26259Erasmus MC30
Recruiting
N/A
Safety and Effectiveness of Endoaortic Balloon Occlusion as Compared to Transthoracic Clamping for Minimally Invasive Mitral Valve SurgeryI34.0Mitral (valve) insufficiency
DRKS00027353niversitätsklinikum Ulm, Kliniken am oberen Eselsberg340