Investigating outcomes in patients after cardiac surgery in the ICU
Assessment of Patients Undergoing Cardiac Surgery and Admitted to the Intensive Care Unit: an Observational, Prospective, Multicenter Study
This study looks at how many patients have complications or die after heart surgery while in the ICU to help improve care for future patients.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hospital Israelita Albert Einstein Academic / other |
| Locations | 1 site (São Paulo) |
| Trial ID | NCT06154473 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the incidence of mortality and early postoperative complications in patients undergoing cardiac surgery who are admitted to the intensive care unit (ICU). It will analyze demographic characteristics, surgical procedures, anesthesia types, and risk factors associated with complications and mortality. The study plans to include 500 patients to develop a robust regression model that identifies key risk factors and outcomes within the first three postoperative days or until ICU discharge. The findings could lead to improved management strategies for this patient population.
Who should consider this trial
Good fit: Ideal candidates are adult patients aged 18 years or older who require postoperative care in the ICU following cardiac surgery.
Not a fit: Patients receiving exclusive palliative care or those with advance directives limiting life support may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance postoperative care and reduce complications for patients undergoing cardiac surgery.
How similar studies have performed: Other studies have shown success in identifying risk factors and improving outcomes in cardiac surgery, making this approach both relevant and potentially impactful.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patients (age 18 years or older). * Cardiac surgeries requiring postoperative care in the ICU. Exclusion Criteria: * Exclusive palliative care or advance directive expressing desire for limitation of life support (cardiopulmonary resuscitation, invasive mechanical ventilation, renal replacement therapy). * Moribund patient. * Surgery for implant of cardiac implantable electronic device (implantable cardioverter defibrillator, cardiac pacemaker). * Patients previously included in this study.
Where this trial is running
São Paulo
- Hospital Israelita Albert Einstein — São Paulo, Brazil (Recruiting)
Study contacts
- Principal investigator: Renato CF Chaves, MD, MBA. — Hospital Israelita Albert Einstein
- Study coordinator: Renato CF Chaves, MD, MBA.
- Email: renato.carneiro@einstein.br
- Phone: +5511984481068
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.