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

NANot yet recruitingINTERVENTIONAL
Enrollment

400

Participants

Timeline

Start Date

December 31, 2025

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2025

Conditions
Coronary Heart Disease (CHD)Cardio-pulmonary BypassCongestive Heart Failure ChronicCardiogenic Shock Acute
Interventions
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%.

Trial Locations (1)

210029

The First Affiliated Hospital of Nanjing Medical University, Nanjing

Sponsors
All Listed Sponsors
collaborator

The First Affiliated Hospital with Nanjing Medical University

OTHER

lead

Nanjing Medical University

OTHER