NCT06154473

Brief Summary

The objective of this study is to investigate the incidence of death and early postoperative complications, identify potential risk factors, and examine the demographic characteristics of patients and epidemiology of cardiovascular procedures. Our hypothesis is that gaining a more comprehensive understanding of the characteristics of patients who undergo cardiac surgery has the potential to improve outcomes for this patient profile. Thus, information was sought regarding the patient characteristics, surgeries performed, anesthesia administered, incidence of intraoperative and postoperative complications, and risk factors associated with complication and mortality in the ICU. The main questions it aims to answer are:

  • Incidence of mortality or severe postoperative complications that occur within the first 3 postoperative days or until discharge from the ICU.
  • Risk factors associated with severe complications in patients who undergo cardiac surgery.
  • Characteristics of patients, anesthesia and surgical procedures performed
  • Incidence of severe intraoperative complications and moderate postoperative complications
  • Evaluate the influence of accumulated fluid balance on outcomes, mortality, and length of ICU stay.
  • Evaluate mortality in the ICU.
  • Describe the risk factors associated with mortality.

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
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2023

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

First Submitted

Initial submission to the registry

July 25, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

December 4, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2024

Completed
Last Updated

December 4, 2023

Status Verified

October 1, 2023

Enrollment Period

1 year

First QC Date

July 25, 2023

Last Update Submit

November 23, 2023

Conditions

Cardiac DiseaseCardiac IschemiaCardiac Valve Disease

Keywords

cardiac surgeryanesthesiacritical caremortalityepidemiology

Outcome Measures

Primary Outcomes (1)

  • Mortality or severe postoperative complications within the first 3 postoperative days or until ICU discharge, whichever occurs first

    Severe postoperative complications are: stroke, septic shock, unscheduled urgent or emergency surgical reoperation, cardiovascular complications, hematological complications, pulmonary complications, and renal complications

    Within the first 3 postoperative days or until ICU discharge, whichever occurs first, assessed up to 3 postoperative days

Secondary Outcomes (8)

  • Evaluate the characteristics of the patients

    Within the first 3 postoperative days or until ICU discharge, whichever occurs first, assessed up to 3 postoperative days

  • Describe the surgeries performed

    Within the first 3 postoperative days or until ICU discharge, whichever occurs first, assessed up to 3 postoperative days

  • Describe the anesthesia performed

    Within the first 3 postoperative days or until ICU discharge, whichever occurs first, assessed up to 3 postoperative days

  • Evaluate the incidence of severe intraoperative complications

    Within the first 3 postoperative days or until ICU discharge, whichever occurs first, assessed up to 3 postoperative days

  • Assess the incidence of other postoperative complications (not included in the primary endpoint)

    Within the first 3 postoperative days or until ICU discharge, whichever occurs first, assessed up to 3 postoperative days

  • +3 more secondary outcomes

Study Arms (2)

Open heart surgery

Cohort of patient undergoing an open heart surgery. Open heart surgery is defined as a surgical procedure that involves making an incision in the chest to opening the chest wall to access and operate on the heart. The study will include patients who undergo valve repair, valve replacement, or coronary artery bypass grafting. In addition, combined surgery, define as valve surgery in combination with coronary artery bypass grafting, will also be included. Heart transplant will not be included.

Procedure: Open heart surgery group.

Percutaneous cardiovascular surgery

Cohort of patient undergoing a percutaneous cardiovascular surgery. Percutaneous cardiovascular surgery is defined as a surgical procedure that involves making an incision in the skin to use a catheter-based approach to access and operate on the heart. The study will include patients who undergo transcatheter aortic valve implantation, valve in valve transcatheter aortic valve implantation and transcatheter mitral-valve repair or replacement.

Procedure: Percutaneous cardiovascular surgery group.

Interventions

Open heart surgery group.PROCEDURE

Patients undergoing open heart surgery.

Open heart surgery
Percutaneous cardiovascular surgery group.PROCEDURE

Patients undergoing percutaneous cardiovascular surgery.

Percutaneous cardiovascular surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Centers with experience in cardiac surgery will be invited to participate in the study. It is planned that patients undergoing cardiac surgery will be included consecutively during the study period, which will be determined later. The study population will consist of patients undergoing open heart surgery or percutaneous cardiovascular surgery, and the following surgeries will be included: valve repair (or replacement) and/or coronary artery bypass grafting.

You may qualify if:

  • Adult patients (age 18 years or older).
  • Cardiac surgeries requiring postoperative care in the ICU.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Israelita Albert Einstein

São Paulo, Brazil

RECRUITING

Related Publications (1)

  • Vasconcelos NNB, Chaves RCF, Pellegrino CM, Souza GM, Queiroz VNF, Barbas CSV, Takaoka F, Cordioli RL, Mangini S, Papa FV, Guimaraes HP, Pereira AJ, Serpa Neto A, Gulinelli A, Legal AC, Jaoude CVG, Paolinelli E, Lineburger EB, Albuquerque ECF, Ferreira Filho EG, Hohmann FB, Galdino F, Vianna FSL, Dall'Orto FTC, Tramujas L, Silva LRP, Goncharov M, Gottardo PC, Rabello Filho R, Midega TD, Galindo VB, Quintao VC, Veiga VC, Correa TD, Silva Junior JM. Multicenter observational study of patients who underwent cardiac surgery and were hospitalized in an intensive care unit (BraSIS 2): study protocol and statistical analysis plan. Crit Care Sci. 2025 Mar 10;37:e20250222. doi: 10.62675/2965-2774.20250222. eCollection 2025.

    PMID: 40072977DERIVED

MeSH Terms

Conditions

Heart DiseasesCoronary Artery DiseaseHeart Valve Diseases

Condition Hierarchy (Ancestors)

Cardiovascular DiseasesCoronary DiseaseMyocardial IschemiaArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Renato CF Chaves, MD, MBA.

    Hospital Israelita Albert Einstein

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Renato CF Chaves, MD, MBA.

CONTACT

+5511984481068renato.carneiro@einstein.br

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 25, 2023

First Posted

December 4, 2023

Study Start

September 1, 2023

Primary Completion

September 1, 2024

Study Completion

November 1, 2024

Last Updated

December 4, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will share

The study database will be accessible to other researchers as part of our plan. The database will be kept under the custody of the study coordinators, and its access could be allowed to third parties after evaluation of the proposal accompanied by a statistical analysis plan and execution of a Data Sharing Agreement. Once the agreement is in place, the database will be made available in an anonymized form. Should be emphasize that no data that allows future identification of the patient will be share. Example of data that will not be share: name, date of birth, individual registration number as Individual Taxpayer Registration (CPF), and medical record number. Each individual requesting access to the database must formally commit to notifying the executive committee of the study of any information that allows the identification of the patient in the database. For more information or to submit a request, please contact renato.carneiro@einstein.br

Shared Documents
STUDY PROTOCOL
Time Frame
Data requests can be submitted starting immediately after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis
Access Criteria
Access to trial individual participant data (IPD) can be requested by qualified researchers engaging in independent scientific research and will be provided following review and approval of a research proposal, review and approval of a statistical analysis plan and execution of a data sharing agreement. No data that allows future identification of the patient will be publicly available. For more information or to submit a request, please contact renato.carneiro@einstein.br

Locations

BR(1)