Cardiac SurgeryHEMO-INTEGRANCT07683299
HEMO-INTEGRA: Integrated Intraoperative Hemodynamic Monitoring During Cardiac Surgery With Cardiopulmonary Bypass - A Pilot Study
An observational study of Cardiac Surgery and Cardiopulmonary Bypass, run by Hernán Darío Castro Arias at 1 site in Colombia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Surgery, Cardiopulmonary Bypass, Hemodynamic Monitoring
- How many people
- 30 participants
- Where
- 1 siteColombia
- Study dates
- 27 May 2026to Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients undergoing elective cardiac surgery with cardiopulmonary bypass at Clinica Medellin Sede Occidente, Medellin, Colombia.
Who may be able to join
- - 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
Who cannot join
- - Emergency surgery
- Off-pump cardiac surgery (OPCAB)
- Inability to obtain adequate TEE window
- Refusal to participate
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Colombia1 site, 1 recruiting
- Recruiting
Clinica Medellin Sede Occidente
Medellín, Antioquia
Hernan D Castro-Arias, MD MSc, +573128633884, hernan_castro@icloud.com
About this study
Official title: HEMO-INTEGRA: Feasibility and Description of an Integrated Intraoperative Hemodynamic Monitoring System for Cardiac Surgery With Cardiopulmonary Bypass - A Pilot Observational 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.
- Conditions
- Cardiac Surgery, Cardiopulmonary Bypass, Hemodynamic Monitoring, Ventricular-Arterial Coupling
- Keywords
- HEMO-INTEGRA, VExUS, Oxygen Delivery, NIRS, Deep Hypothermia, Transesophageal Echocardiography, Clinical Decision Support
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| HEMO-INTEGRA Cohort | Adult patients undergoing elective cardiac surgery with cardiopulmonary bypass monitored with the HEMO-INTEGRA integrated hemodynamic monitoring system across five intraoperative time points (T0 to T4). Intervention Name : HEMO-INTEGRA v2.0 Software system for integrated intraoperative hemodynamic monitoring integrating ventricular-arterial coupling (Balan 2026), tissue perfusion (EPOC/Q10), neuromonitoring (NIRS/BIS), and venous congestion (VExUS-TEE). Operates in parallel with standard care without modifying clinical management. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Data Capture Completeness
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.
Measured: Intraoperative (0 to 6 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2026
- Study start27 May 2026
- Primary completionDec 2026 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hernán Darío Castro Arias
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hernán Darío Castro Arias, Hernán Darío Castro Arias MD MSc
- Investigators
- Hernan D Castro-Arias, MD MSc, Principal investigator, Clinica Medellin Sede Occidente, Grupo Quiron Salud
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07683299
- Sponsor's protocol ID
- HI-PILOT-2026-001
- Acronym
- HEMO-INTEGRA
- Status last verified
- Jun 2026
- First submitted
- 27 Jun 2026
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to the pilot nature of this study and local institutional privacy regulations. Aggregate results will be reported in peer-reviewed publications.
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HEMO-INTEGRA: Feasibility and Description of an Integrated Intraoperative Hemodynamic Monitoring System for Cardiac Surgery With Cardiopulmonary Bypass - A Pilot Observational Study
- ClinicalTrials.gov ID
- NCT07683299
- Acronym / sponsor ID
- HEMO-INTEGRA / HI-PILOT-2026-001
- Conditions
- Cardiac Surgery, Cardiopulmonary Bypass, Hemodynamic Monitoring, Ventricular-Arterial Coupling
- Keywords
- HEMO-INTEGRA, VExUS, Oxygen Delivery, NIRS, Deep Hypothermia, Transesophageal Echocardiography, Clinical Decision Support
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hernán Darío Castro AriasUniversity, hospital or other
- Study start
- 27 May 2026 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 6 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HEMO-INTEGRA Cohort | – | –Adult patients undergoing elective cardiac surgery with cardiopulmonary bypass monitored with the HEMO-INTEGRA integrated hemodynamic monitoring system across five intraoperative time points (T0 to T4). Intervention Name : HEMO-INTEGRA v2.0 Software system for integrated intraoperative hemodynamic monitoring integrating ventricular-arterial coupling (Balan 2026), tissue perfusion (EPOC/Q10), neuromonitoring (NIRS/BIS), and venous congestion (VExUS-TEE). Operates in parallel with standard care without modifying clinical management. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients undergoing elective cardiac surgery with cardiopulmonary bypass at Clinica Medellin Sede Occidente, Medellin, Colombia.
Key inclusion criteria (3 listed)
- - 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
Key exclusion criteria (4 listed)
- - Emergency surgery
- Off-pump cardiac surgery (OPCAB)
- Inability to obtain adequate TEE window
- Refusal to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to the pilot nature of this study and local institutional privacy regulations. Aggregate results will be reported in peer-reviewed publications.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hernan D Castro-Arias, MD MSc principal investigator
Clinica Medellin Sede Occidente, Grupo Quiron Salud
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Surgery and Cardiopulmonary Bypass, run by Hernán Darío Castro Arias at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hernan D Castro-Arias, MD MSc (+573128633884, hernan_castro@icloud.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Data Capture Completeness (time frame: Intraoperative (0 to 6 hours)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.