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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03857906
Other study ID # .2018
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 21, 2014
Est. completion date January 19, 2019

Study information

Verified date March 2019
Source CMN "20 de Noviembre"
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

Background: The intra-aortic balloon balloon pump (IABP) has been used as a method of percutaneous circulatory assistance high surgical risk patients undergoing coronary artery bypass graft surgery (CABG); Although its applicability has been questioned by clinical trials showing poor impact to reduce the mortality due to cardiogenic shock associated with postoperative acute myocardial infarction (AMI), the real benefit reducing mortality in the postoperative context (PO) has not been determined examined through a prospective study with an adequate design.

Objective: To compare PO complications such as mortality, perioperative infarction and other complications in patients with high surgical risk undergoing CABG in comparison with controls.


Description:

Methods: Quasi-experimental, prospective, comparative, non-randomized study. The decision to place the BIAC is not part of the study and depends on the multidisciplinary decision of a Heart Team, based on the individualized risk / benefit. The study population consists on high surgical risk patients with atherosclerotic coronary disease undergoing CABG in our centre between 2014-2018. Patients are excluded if any condition is present: cardiogenic shock, with AMI 48 hours prior and / or severe aortic insufficiency. In one group BIAC will be inserted 1-6 hours before surgery (BIAC group) and a second group is control (non-BIAC group). A minimum 30-day postoperative follow-up of will be performed, with primary end points (mortality and AMI type V) and secondary end points (additional PO complications).

Analysis: An evaluation of normality distribution K-S will be performed, the means of quantitative (t-Test) and categorical variables (Fisher or χ² Pearson) will be compared. A multivariate analysis will be performed with linear logistic regression to evaluate the influence of age, sex, peripheral arterial disease (PAD) and EuroSCORE-II on the primary goal. Statistical significance will be considered when p <0.05. Softwares: GraphPad-Prism-5.0 and SPSS-15.0


Recruitment information / eligibility

Status Completed
Enrollment 129
Est. completion date January 19, 2019
Est. primary completion date February 21, 2018
Accepts healthy volunteers
Gender All
Age group 18 Years to 99 Years
Eligibility Inclusion Criteria:

- All patients greater than 18 years

- Scheduled for coronary artery bypass graft (CABG) surgery were eligible

- Multiple vessel disease with or without left main coronary artery (LMCA) significant stenosis (>50%)

- Written informed consent provided

Exclusion Criteria:

- Prior cardiogenic shock,

- Acute myocardial infarction (AMI) less than 48 hours prior to enrollment

- Previous IABP use

- AMI mechanical complications

- Aortic regurgitation greater than grade II in severity (on a scale of I to IV, with higher grades indicating more severe regurgitation)

- Tachyarrhythmia

- Other aortic procedures

- Other non-CABG surgical procedures

- Massive pulmonary embolism

- Older than 90 years of age

- Any coagulopathy

- Severe concomitant disease associated with a life expectancy of less than 6 months.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Intra-Aortic Ballon Pump insertion
The IABP (Ultraflex IAB 7.5F, 2.5mm; Arrow International, Reading, PA) was inserted percutaneously through the right femoral artery in the previous 1 - 6 hours before the scheduled surgery. Positioning of the IABP was guided by radioscopy. The balloon size was based on the patient's height (30, 40 or 50 cc). Transesophageal echocardiography was used to confirm correct IABP placement before and after CABG

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
CMN "20 de Noviembre" Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado

Outcome

Type Measure Description Time frame Safety issue
Primary 30-Day All-Cause Mortality 30-Day Mortality 30 days
Primary 30-Day Postoperative Myocardial Infarction Based on the third universal definition on MI criteria 30 days
Secondary 30-day occurrence rate of PCI 30-day occurrence rate of emergent percutaneous coronary intervention 30 days
Secondary Requirement of mechanical ventilation Requirement of mechanical ventilation for longer than 24 hours 30 days
Secondary acute kidney injury AKIN classification 30 days
Secondary Need for renal replacement therapy Need for RRT (hemodialysis, peritoneal) 30 days
Secondary ICU length of stay ICU and in-hospital length of stay 30 days
Secondary Postoperative use of inotropes and vasopressors Postoperative use of inotropes and vasopressors 30 days
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