NCT06728605

Protective Effect of EECP Against Negative Inflammatory Response and Organ Dysfunction After Cardiovascular Surgery

Protective Effect of Enhanced External Counterpulsation Against Negative Inflammatory Response and Organ Dysfunction After Cardiovascular Surgery

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: Nanjing Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Enhanced external counterpulsation (EECP) is a noninvasive, non-pharmacologic intervention proven to increase nitric oxide bioavailability in patients with coronary artery disease. Although EECP showed short-term effects in improving coronary flow in patients with coronary slow flow, whether such improvement is durable remains uncertain, and the relationships between such improvement and changes in multiple organ functions as well as inflammatory markers have not been elucidated. The purpose of this study will be to evaluate the potential clinical benefits of EECP on organ function and proinflammatory cytokine concentrations during post-acute sequela of cardiovascular surgery.

Conditions

• Coronary Heart Disease (CHD)
• Cardio-pulmonary Bypass
• Congestive Heart Failure Chronic
• Cardiogenic Shock Acute

Interventions

Type	Name	Description
DEVICE	Enhanced External Counterpulsation (EECP)	Patients randomly assigned to EECP received 3 1/2-h sessions of EECP for 3 days before surgery. Three pneumatic cuffs will be placed around the lower limbs and buttocks and will be inflated sequentially upward at the onset of diastole, and released rapidly and simultaneously before the onset of systole. The protocol-specified applied pressure will be 300 mm Hg and was reached within 5 min of the initiation of treatment. Pulse oximetry will be monitored continuously during the treatment session, and the subject's clinical status will be re-evaluated if the oxygen saturation drops by 4%.
DEVICE	Sham Comparator	Patients randomly assigned to sham group received 3 1/2-h sessions of sham treatment for 3 days before surgery. Three pneumatic cuffs will be placed around the lower limbs and buttocks and will be inflated sequentially upward at the onset of diastole, and released rapidly and simultaneously before the onset of systole. The protocol-specified applied pressure will be 70 mm Hg and was reached within 5 min of the initiation of treatment. Pulse oximetry will be monitored continuously during the treatment session, and the subject's clinical status will be re-evaluated if the oxygen saturation drops by 4%.

Timeline

• Start date: 2025-12-31
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2024-12-11
• Last updated: 2024-12-11

Locations

1 site across 1 country: China