Cardiac DiseaseNCT04759222
Microvascular Reactivity in Cardiac Surgery
An observational study of Cardiac Disease, run by Pusan National University Hospital at 1 site in South Korea.
Trial summary
Microcirculatory disturbance occurs most seriously during cardiopulmonary bypass (CPB) in cardiac surgery. If microvascular reactivity compensates for microcirculatory disturbance during CPB, tissue hypoxemia may be minimized. On the other hand, tissue hypoxemia may develop and lead to poor clinical outcomes. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Cardiac Disease
- What is being tested?
- vascular occlusion test
- Type of treatment
- Injection or infusion
- How many people
- 115 participants
- Where
- 1 siteSouth Korea
- Study dates
- 14 Feb 2017to 28 Jun 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients aged >18 years scheduled for elective on-pump cardiac surgery in Pusan National University Hospital.
Who may be able to join
- adult patients aged >18 years
- elective on-pump cardiac surgery
Who cannot join
- pregnancy
- inability to tolerate VOT (e.g., patients with arm deformities, arteriovenous shunts, burns)adult patients aged >18 years scheduled for elective on-pump cardiac surgery
- refusal to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Microvascular Reactivity as a Predictor of Major Adverse Events in Patients With On-pump Cardiac Surgery: A Prospective Observational Study
Microcirculatory disturbance occurs most seriously during cardiopulmonary bypass (CPB) in cardiac surgery. If microvascular reactivity compensates for microcirculatory disturbance during CPB, tissue hypoxemia may be minimized. On the other hand, tissue hypoxemia may develop and lead to poor clinical outcomes. The primary aim of this study was to assess whether microvascular reactivity during CPB can predict major adverse events (MAE) within 30 days after cardiac surgery.
This prospective, observational, single-center study was conducted on 115 patients who underwent elective on-pump cardiac surgery. The vascular occlusion test (VOT) with near-infrared spectroscopy was performed five times for each patient, before the induction of general anesthesia (baseline, T0), 30 min after the induction of general anesthesia (T1), 30 min after applying CPB (T2), 10 min after injection of protamine (T3), and after sternal closure (T4). Sequential Organ Failure Assessment (SOFA) and Acute Physiologic and Chronic Health Evaluation (APACHE) II scores and the length of ventilator care, intensive care unit stay, and hospital stay were recorded. Postoperative MAE within 30 days after surgery was also recorded.
Read the detailed description
The VOT was performed five times in each patient, before the induction of general anesthesia (baseline, T0), 30 min after the induction of general anesthesia (T1), 30 min after applying CPB (T2), 10 min after injection of protamine (T3), and after sternal closure (T4). Before induction of anesthesia, an NIRS sensor (INVOS® 5100C Cerebral/Somatic Oximeter; Medtronic, Minneapolis, MN, USA) was placed on the thenar eminence and an automated tourniquet (A.T.S® 3000 Automatic Tourniquet System; Zimmer Inc., Warsaw, IL, USA) was placed around the upper arm. The arterial catheter was placed in the contralateral radial artery and the baseline blood pressure was measured. When the baseline tissue oxygen saturation (StO2) was stabilized, the automatic tourniquet was inflated to 50 mmHg over the patient's baseline systolic blood pressure and maintained for 5 min. After the 5-min ischemic period, the tourniquet rapidly deflated to 0 mmHg. StO2 data were continuously recorded during the VOT procedure. Baseline StO2, minimum StO2 during the 5-min inflation of the tourniquet, and maximum StO2 during deflation of the tourniquet were obtained. The occlusion slope and recovery slope were calculated based on the measured StO2 data. The occlusion slope, which is related to oxygen extraction, was defined as the slope of the StO2 descent to the lowest value. The recovery slope, which is related to microvascular reactivity, was calculated from the deflation of the tourniquet until the recovery of StO2 to the highest value.
- Conditions
- Cardiac Disease
- Being tested
- vascular occlusion test
- Medical subject headings
- Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vascular occlusion testDiagnostic test
The VOT was performed five times in each patient, before the induction of general anesthesia (baseline, T0), 30 min after the induction of general anesthesia (T1), 30 min after applying CPB (T2), 10 min after injection of protamine (T3), and after sternal closure (T4). Before induction of anesthesia, an NIRS sensor was placed on the thenar eminence and an automated tourniquet was placed around the upper arm. The arterial catheter was placed in the contralateral radial artery and the baseline blood pressure was measured. When the baseline tissue oxygen saturation (StO2) was stabilized, the automatic tourniquet was inflated to 50 mmHg over the patient's baseline systolic blood pressure and maintained for 5 min. After the 5-min ischemic period, the tourniquet rapidly deflated to 0 mmHg. StO2 data were continuously recorded during the VOT procedure.
What is being measured
The primary outcome is the main question the study is designed to answer.
Recovery slope
Recovery slope is related to microvascular reactivity, was calculated from the deflation of the tourniquet until the recovery of tissue oxygen saturation to the highest value.
Measured: during applying cardiopulmonary bypass, an average 1-2 hours
Major adverse events
death, acute kidney injury, myocardial infarction, acute respiratory distress syndrome, aggravated heart failure, gastrointestinal bleeding
Measured: within postoperative 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2021
- Study start14 Feb 2017
- Primary completion30 May 2019
- Study completion28 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac DiseaseStudies 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
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pusan National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hyeon-Jeong Lee, Pusan National University Hospital
- Investigators
- Heon-Jeong Lee, PhD, Principal investigator, Pusan National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04759222
- Sponsor's protocol ID
- 1702-003-051
- Status last verified
- Feb 2021
- First submitted
- 10 Feb 2021
- Last updated
- 18 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microvascular Reactivity as a Predictor of Major Adverse Events in Patients With On-pump Cardiac Surgery: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT04759222
- Acronym / sponsor ID
- 1702-003-051
- Conditions
- Cardiac Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Pusan National University HospitalUniversity, hospital or other
- Study start
- 14 Feb 2017 (actual)
- Primary completion
- 30 May 2019 (actual)
- Study completion
- 28 Jun 2019 (actual)
- First posted
- 18 Feb 2021 (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.
Microcirculatory disturbance occurs most seriously during cardiopulmonary bypass (CPB) in cardiac surgery. If microvascular reactivity compensates for microcirculatory disturbance during CPB, tissue hypoxemia may be minimized. On the other hand, tissue hypoxemia may develop and lead to poor clinical outcomes. The primary aim of this study was to assess whether microvascular reactivity during CPB can predict major adverse events (MAE) within 30 days after cardiac surgery.
This prospective, observational, single-center study was conducted on 115 patients who underwent elective on-pump cardiac surgery. The vascular occlusion test (VOT) with near-infrared spectroscopy was performed five times for each patient, before the induction of general anesthesia (baseline, T0), 30 min after the induction of general anesthesia (T1), 30 min after applying CPB (T2), 10 min after injection of protamine (T3), and after sternal closure (T4). Sequential Organ Failure Assessment (SOFA) and Acute Physiologic and Chronic Health Evaluation (APACHE) II scores and the length of ventilator care, intensive care unit stay, and hospital stay were recorded. Postoperative MAE within 30 days after surgery was also recorded.
Detailed description
The VOT was performed five times in each patient, before the induction of general anesthesia (baseline, T0), 30 min after the induction of general anesthesia (T1), 30 min after applying CPB (T2), 10 min after injection of protamine (T3), and after sternal closure (T4). Before induction of anesthesia, an NIRS sensor (INVOS® 5100C Cerebral/Somatic Oximeter; Medtronic, Minneapolis, MN, USA) was placed on the thenar eminence and an automated tourniquet (A.T.S® 3000 Automatic Tourniquet System; Zimmer Inc., Warsaw, IL, USA) was placed around the upper arm. The arterial catheter was placed in the contralateral radial artery and the baseline blood pressure was measured. When the baseline tissue oxygen saturation (StO2) was stabilized, the automatic tourniquet was inflated to 50 mmHg over the patient's baseline systolic blood pressure and maintained for 5 min. After the 5-min ischemic period, the tourniquet rapidly deflated to 0 mmHg. StO2 data were continuously recorded during the VOT procedure. Baseline StO2, minimum StO2 during the 5-min inflation of the tourniquet, and maximum StO2 during deflation of the tourniquet were obtained. The occlusion slope and recovery slope were calculated based on the measured StO2 data. The occlusion slope, which is related to oxygen extraction, was defined as the slope of the StO2 descent to the lowest value. The recovery slope, which is related to microvascular reactivity, was calculated from the deflation of the tourniquet until the recovery of StO2 to the highest value.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients aged >18 years scheduled for elective on-pump cardiac surgery in Pusan National University Hospital.
Key inclusion criteria (2 listed)
- adult patients aged >18 years
- elective on-pump cardiac surgery
Key exclusion criteria (3 listed)
- pregnancy
- inability to tolerate VOT (e.g., patients with arm deformities, arteriovenous shunts, burns)adult patients aged >18 years scheduled for elective on-pump cardiac surgery
- refusal to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| vascular occlusion testThe VOT was performed five times in each patient, before the induction of general anesthesia (baseline, T0), 30 min after the induction of general anesthesia (T1), 30 min after applying CPB (T2), 10 min after injection of protamine (T3), and after sternal closure (T4). Before induction of anesthesia, an NIRS sensor was placed on the thenar eminence and an automated tourniquet was placed around the upper arm. The arterial catheter was placed in the contralateral radial artery and the baseline blood pressure was measured. When the baseline tissue oxygen saturation (StO2) was stabilized, the automatic tourniquet was inflated to 50 mmHg over the patient's baseline systolic blood pressure and maintained for 5 min. After the 5-min ischemic period, the tourniquet rapidly deflated to 0 mmHg. StO2 data were continuously recorded during the VOT procedure. | Diagnostic test | – |
Primary outcome
Recovery slope
Time frame: during applying cardiopulmonary bypass, an average 1-2 hours
Recovery slope is related to microvascular reactivity, was calculated from the deflation of the tourniquet until the recovery of tissue oxygen saturation to the highest value.
Major adverse events
Time frame: within postoperative 30 days
death, acute kidney injury, myocardial infarction, acute respiratory distress syndrome, aggravated heart failure, gastrointestinal bleeding
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2021.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Heon-Jeong Lee, PhD principal investigator
Pusan National University Hospital
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 Disease, run by Pusan National University Hospital at 1 site in South Korea.
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 2 inclusion and 3 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: finished, as of the sponsor's last update on 18 Feb 2021. 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 South Korea. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recovery slope (time frame: during applying cardiopulmonary bypass, an average 1-2 hours). The study lists 2 primary outcomes in all. 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 18 Feb 2021.