Postoperative; Dysfunction Following Cardiac SurgeryIABCSNCT02143544
Intra-aortic Balloon Counterpulsation in Patients Undergoing Cardiac Surgery
A study testing Intra-aortic balloon pump. in people with Postoperative; Dysfunction Following Cardiac Surgery, run by University of Sao Paulo at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Postoperative; Dysfunction Following Cardiac Surgery
- What is being tested?
- Intra-aortic balloon pump.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteBrazil
- Study dates
- Apr 2014to Apr 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Cardiogenic shock
- Acute myocardial infarction (AMI) < 48 hours
- Mechanical complications of AMI
- Peripheral vascular disease (aorta, iliac or femoral)
- Severe aortic regurgitation
- Neoplasm
Show all 13Show fewer
- Pregnancy
- Tachyarrhythmia
- Procedures of the aorta
- Coagulopathy
- Thrombocytopenia
- Cardiac transplantation, congenital heart disease or endocarditis
- Refusal to consent
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Heart Institute
São Paulo, São Paulo, 05403000
Ludhmila A Hajjar, PhD, 11-26615232, ludhmila@usp.br
Graziela Ferreira, Dr, 11-26615367, gsrf@uol.com.br
About this study
Official title: Intra-aortic Balloon Counterpulsation in Patients Undergoing Cardiac Surgery: a Randomized Controlled Trial
The hypothesis of the study is to evaluate if the preoperative placement of IABP reduces clinical complications in high-risk patients undergoing cardiac surgery.
Read the detailed description
High-risk patients undergoing cardiac surgery are at high risk for myocardial ischemia, arrhythmia, cardiogenic shock and other clinical complications. Different therapeutic options are available to support these patients in the perioperative period including inotropes, vasopressors, and vasodilators, and also assist devices such as intra-aortic balloon pump (IABP) and others.
IABP increases myocardial oxygen supply by increasing diastolic coronary perfusion pressure and decreases myocardial oxygen demand by reducing left ventricular afterload. Additionally, IABP can also improve cardiac output and systemic perfusion. The hypothesis of this randomized and controlled trial is that the placement of IABP immediately before the cardiac surgery reduces clinical complications in high-risk patients.
- Being tested
- Intra-aortic balloon pump.
- Keywords
- Intra-aortic balloon counterpulsation, Cardiac surgery, High-risk patients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intra-aortic balloon pump.Device
Preoperative placement of the intra-aortic balloon pump.
| Study group | Role | What they receive |
|---|---|---|
| Preoperative intra-aortic balloon pump. | Active comparator | Intervention: Preoperative placement of the intra-aortic balloon pump. Receives: Device: Intra-aortic balloon pump. |
| Control | No intervention | No preoperative placement of the intra-aortic balloon pump. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days
Secondary outcomes (15)
Duration of mechanical ventilation
Number of days during mechanical ventilation.
Measured: 30 days
IABP complications
Number of patients presenting one of the following: lower limb ischemia, mesenteric ischemia or bleeding.
Measured: 30 days
Use of vasoactive agents
Number of days and dose of inotropes and vasopressors.
Measured: 30 days
Evaluation of hemodynamic data
Comparison of the following hemodynamic data between groups: heart rate, arterial pressure and cardiac output.
Measured: 48 hours
Levels of biomarkers
Comparison of the following biomarker levels between groups: pro-BNP (Brain natriuretic peptide), troponin I and Neutrophil gelatinase-associated lipocalin (NGAL), Heart-type Fatty Acid Binding Protein (H-FABP)
Measured: 7 days
Echocardiographic parameters
Comparison of the following echocardiographic parameters between groups: left ventricular ejection fraction, cardiac output, left ventricular diastolic diameter, left ventricular systolic diameter and wall motion abnormalities.
Measured: 7 days
30-day mortality
Death during hospital stay or death after hospital discharge until 30 days following the procedure
Measured: 30 days
60-days mortality
Death until 60 days following the procedure
Measured: 60 days
1-year mortality
Death until 1 year following the procedure
Measured: 1 year
Costs
Comparison of overall costs between groups.
Measured: 30 days
Acute Kidney Injury
Incidence of acute kidney injury according the Acute Kidney Injury Network (AKIN) classification.
Measured: 30 days
Cardiovascular complications
Arrhythmias or myocardial ischemia within 30 days after randomization
Measured: 30 days
Infectious complications
New infection or septic shock within 30 days after randomization
Measured: 30 days
Delirium
Acute cognitive dysfunction diagnosed with the use of the CAM-ICU scale within 30 days after randomization
Measured: 30 days
Bleeding
Blood losses exceeding 100-300 mL per hour following ICU admission
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2014 (estimated)
- Study startApr 2014
- Primary completionApr 2016 (estimated)
- Study completionApr 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Postoperative; Dysfunction Following Cardiac SurgeryStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ludhmila Abrahão Hajjar, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02143544
- Sponsor's protocol ID
- Heart Institute
- Acronym
- IABCS
- Status last verified
- Feb 2016
- First submitted
- 30 Apr 2014
- Last updated
- 4 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 31773324Caldas 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.
PubMed 30503909
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra-aortic Balloon Counterpulsation in Patients Undergoing Cardiac Surgery: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02143544
- Acronym / sponsor ID
- IABCS / Heart Institute
- Keywords
- Intra-aortic balloon counterpulsation, Cardiac surgery, High-risk patients
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Apr 2016 (estimated)
- Study completion
- Apr 2016 (estimated)
- First posted
- 21 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The hypothesis of the study is to evaluate if the preoperative placement of IABP reduces clinical complications in high-risk patients undergoing cardiac surgery.
Detailed description
High-risk patients undergoing cardiac surgery are at high risk for myocardial ischemia, arrhythmia, cardiogenic shock and other clinical complications. Different therapeutic options are available to support these patients in the perioperative period including inotropes, vasopressors, and vasodilators, and also assist devices such as intra-aortic balloon pump (IABP) and others.
IABP increases myocardial oxygen supply by increasing diastolic coronary perfusion pressure and decreases myocardial oxygen demand by reducing left ventricular afterload. Additionally, IABP can also improve cardiac output and systemic perfusion. The hypothesis of this randomized and controlled trial is that the placement of IABP immediately before the cardiac surgery reduces clinical complications in high-risk patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Preoperative intra-aortic balloon pump. | Active comparator | Device: Intra-aortic balloon pump.Intervention: Preoperative placement of the intra-aortic balloon pump. |
| Control | No intervention | –No preoperative placement of the intra-aortic balloon pump. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (13 listed)
- Cardiogenic shock
- Acute myocardial infarction (AMI) < 48 hours
- Mechanical complications of AMI
- Peripheral vascular disease (aorta, iliac or femoral)
- Severe aortic regurgitation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intra-aortic balloon pump.Preoperative placement of the intra-aortic balloon pump. | Device | Preoperative intra-aortic balloon pump. |
Primary outcome
Composite 30-day mortality or major morbidity (mechanical ventilation > 24 hours, mediastinitis, surgical reexploration, stroke, cardiogenic shock, acute renal failure)
Time frame: 30 days
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.
15 secondary outcomes
Duration of mechanical ventilation
Time frame: 30 days
IABP complications
Time frame: 30 days
Use of vasoactive agents
Time frame: 30 days
Evaluation of hemodynamic data
Time frame: 48 hours
Levels of biomarkers
Time frame: 7 days
Echocardiographic parameters
Time frame: 7 days
30-day mortality
Time frame: 30 days
60-days mortality
Time frame: 60 days
1-year mortality
Time frame: 1 year
Costs
Time frame: 30 days
Acute Kidney Injury
Time frame: 30 days
Cardiovascular complications
Time frame: 30 days
Infectious complications
Time frame: 30 days
Delirium
Time frame: 30 days
Bleeding
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2016.
- Derived from this study: PubMed 31773324Caldas 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.
- Derived from this study: PubMed 30503909Caldas 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intra-aortic balloon pump. in people with Postoperative; Dysfunction Following Cardiac Surgery, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ludhmila A Hajjar, PhD (11-26625232, ludhmila@usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite 30-day mortality or major morbidity (mechanical ventilation > 24 hours, mediastinitis, surgical reexploration, stroke, cardiogenic shock, acute renal failure) (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02143544, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2016.