Microvascular Reactivity in Cardiac Surgery

NCT04759222 | Completed

• 1 other identifier: 1702-003-051
• Study Type: observational
• Target: 115
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Cardiac Disease

Outcome Measures

Primary Outcomes (2)

• 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.

  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

  within postoperative 30 days

Interventions

vascular occlusion test DIAGNOSTIC_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.

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult patients aged \>18 years scheduled for elective on-pump cardiac surgery in Pusan National University Hospital.

You may qualify if:

• adult patients aged \>18 years
• elective on-pump cardiac surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• Pusan National University Hospital: lead

Study Sites (1)

Pusan National University Hospital

Busan, 49241, South Korea

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

whole blood

MeSH Terms

Conditions

Heart Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Officials

• Heon-Jeong Lee, PhD

  Pusan National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 10, 2021
• First Posted: February 18, 2021
• Study Start: February 14, 2017
• Primary Completion: May 30, 2019
• Study Completion: June 28, 2019
• Last Updated: February 18, 2021

Record last verified: 2021-02

Locations

KR (1)