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NCT Number: NCT07683299

HEMO-INTEGRA: Integrated Intraoperative Hemodynamic Monitoring During Cardiac Surgery With Cardiopulmonary Bypass - A Pilot Study

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.

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Key information

Conditions

Cardiac Surgery Cardiopulmonary Bypass Hemodynamic Monitoring Ventricular-Arterial Coupling

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinica Medellin Sede Occidente

Medellín, Antioquia, Colombia

Location status: Recruiting

Location contact

Hernan D Castro-Arias, MD MSc

CONTACT

[email protected]

+573128633884

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Data Capture Completeness

    Time frame: Intraoperative (0 to 6 hours)

    Proportion of cases with complete data capture across all five intraoperative time points (T0 to T4) for all four HEMO-INTEGRA monitoring modules: ventricular-arterial coupling, tissue perfusion, neuromonitoring, and venous congestion assessment.

Study contacts

Contact information is provided by the study sponsor or research team.

Hernan D Castro-Arias, MD MSc

CONTACT

[email protected]

+573128633884

Sponsors and collaborators

Lead sponsor

Hernán Darío Castro Arias

Other

Registry information

Official study title

HEMO-INTEGRA: Feasibility and Description of an Integrated Intraoperative Hemodynamic Monitoring System for Cardiac Surgery With Cardiopulmonary Bypass - A Pilot Observational Study

Acronym: HEMO-INTEGRA

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Jul 6, 2026
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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