NCT07683299 HEMO-INTEGRA: Integrated Intraoperative Hemodynamic Monitoring During Cardiac Surgery With Cardiopulmonary Bypass - A Pilot Study
| NCT ID | NCT07683299 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hernán Darío Castro Arias |
| Condition | Cardiac Surgery |
| Study Type | OBSERVATIONAL |
| Enrollment | 30 participants |
| Start Date | 2026-05-27 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 30 participants in total. It began in 2026-05-27 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
HEMO-INTEGRA is a software system that integrates four domains of intraoperative hemodynamic monitoring in a single dashboard during cardiac surgery with cardiopulmonary bypass (CPB): (1) ventricular-arterial coupling (VAC) analysis using the Balan 2026 method; (2) tissue perfusion and oxygen delivery (EPOC module with Q10 temperature correction); (3) neuromonitoring (NIRS/BIS); and (4) systemic venous congestion assessment via VExUS-TEE (Waldron 2024 method). This pilot observational study evaluates the feasibility and completeness of data capture using HEMO-INTEGRA across five perioperative time points (T0: pre-CPB; T1: early CPB; T2: mid-CPB; T3: rewarming; T4: post-CPB) in adult patients undergoing elective cardiac surgery at Clinica Medellin Sede Occidente, Medellin, Colombia. The system operates in parallel with standard monitoring and does not modify clinical management. No additional procedures are performed on participants beyond standard of care.
Eligibility Criteria
Inclusion Criteria: * \- Adult patients 18 years or older scheduled for elective cardiac surgery with cardiopulmonary bypass * Standard intraoperative TEE and arterial line monitoring in place * Written informed consent obtained Exclusion Criteria: * \- Emergency surgery * Off-pump cardiac surgery (OPCAB) * Inability to obtain adequate TEE window * Refusal to participate
Contact & Investigator
Hernan D Castro-Arias, MD MSc
PRINCIPAL INVESTIGATOR
Clinica Medellin Sede Occidente, Grupo Quiron Salud
Frequently Asked Questions
Who can join the NCT07683299 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cardiac Surgery. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07683299 currently recruiting?
Yes, NCT07683299 is actively recruiting participants. Contact the research team at hernan_castro@icloud.com for enrollment information.
Where is the NCT07683299 trial being conducted?
This trial is being conducted at Medellín, Colombia.
Who is sponsoring the NCT07683299 clinical trial?
NCT07683299 is sponsored by Hernán Darío Castro Arias. The principal investigator is Hernan D Castro-Arias, MD MSc at Clinica Medellin Sede Occidente, Grupo Quiron Salud. The trial plans to enroll 30 participants.