NCT02143544

Brief Summary

The hypothesis of the study is to evaluate if the preoperative placement of IABP reduces clinical complications in high-risk patients undergoing cardiac surgery.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

April 30, 2014

Completed
21 days until next milestone

First Posted

Study publicly available on registry

May 21, 2014

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

February 4, 2016

Status Verified

February 1, 2016

Enrollment Period

2 years

First QC Date

April 30, 2014

Last Update Submit

February 3, 2016

Conditions

Postoperative; Dysfunction Following Cardiac Surgery

Keywords

Intra-aortic balloon counterpulsationCardiac surgeryHigh-risk patients

Outcome Measures

Primary Outcomes (1)

  • Composite 30-day mortality or major morbidity (mechanical ventilation > 24 hours, mediastinitis, surgical reexploration, stroke, cardiogenic shock, acute renal failure)

    Composite outcome of 30-day mortality or incidence of patients presenting a major complication according to modified Society of Thoracic Surgeons (STS): mechanical ventilation \> 24 hours, deep sternal wound infection/mediastinitis, surgical reexploration, stroke, cardiogenic shock and acute renal failure.

    30 days

Secondary Outcomes (15)

  • Duration of mechanical ventilation

    30 days

  • IABP complications

    30 days

  • Use of vasoactive agents

    30 days

  • Evaluation of hemodynamic data

    48 hours

  • Levels of biomarkers

    7 days

  • +10 more secondary outcomes

Study Arms (2)

Preoperative intra-aortic balloon pump.

ACTIVE COMPARATOR

Intervention: Preoperative placement of the intra-aortic balloon pump.

Device: Intra-aortic balloon pump.

Control

NO INTERVENTION

No preoperative placement of the intra-aortic balloon pump.

Interventions

Intra-aortic balloon pump.DEVICE

Preoperative placement of the intra-aortic balloon pump.

Preoperative intra-aortic balloon pump.

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age equal to or higher than 18 years old
  • EuroSCORE equal to or higher than 6 or ejection fraction equal to or lower than 40%
  • Written informed consent

You may not qualify if:

  • Cardiogenic shock
  • Acute myocardial infarction (AMI) \< 48 hours
  • Mechanical complications of AMI
  • Peripheral vascular disease (aorta, iliac or femoral)
  • Severe aortic regurgitation
  • Neoplasm
  • Pregnancy
  • Tachyarrhythmia
  • Procedures of the aorta
  • Coagulopathy
  • Thrombocytopenia
  • Cardiac transplantation, congenital heart disease or endocarditis
  • Refusal to consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Heart Institute

São Paulo, São Paulo, 05403000, Brazil

RECRUITING

Related Publications (2)

  • Caldas JR, Panerai RB, Bor-Seng-Shu E, Ferreira GSR, Camara L, Passos RH, Salinet AM, Azevedo DS, de-Lima-Oliveira M, Galas FRBG, Fukushima JT, Nogueira R, Taccone FS, Landoni G, Almeida JP, Robinson TG, Hajjar LA. Intra-aortic balloon pump does not influence cerebral hemodynamics and neurological outcomes in high-risk cardiac patients undergoing cardiac surgery: an analysis of the IABCS trial. Ann Intensive Care. 2019 Nov 27;9(1):130. doi: 10.1186/s13613-019-0602-z.

    PMID: 31773324DERIVED

  • Caldas JR, Panerai RB, Bor-Seng-Shu E, Ferreira GSR, Camara L, Passos RH, de-Lima-Oliveira M, Galas FRBG, Almeida JP, Nogueira RC, Mian N, Gaiotto FA, Robinson TG, Hajjar LA. Dynamic cerebral autoregulation: A marker of post-operative delirium? Clin Neurophysiol. 2019 Jan;130(1):101-108. doi: 10.1016/j.clinph.2018.11.008. Epub 2018 Nov 22.

    PMID: 30503909DERIVED

MeSH Terms

Interventions

Intra-Aortic Balloon Pumping

Intervention Hierarchy (Ancestors)

CounterpulsationAssisted CirculationSurgical Procedures, Operative

Central Study Contacts

Ludhmila A Hajjar, PhD

CONTACT

11-26625232ludhmila@usp.br

Graziela Ferreira, Dr

CONTACT

11-26615367gsrf@uol.com.br

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Cardiology, University of Sao Paulo

Study Record Dates

First Submitted

April 30, 2014

First Posted

May 21, 2014

Study Start

April 1, 2014

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

February 4, 2016

Record last verified: 2016-02

Locations

BR(1)