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The Effect of Remote Ischemic Preconditioning in the Cardiac Surgery

The Effect of Remote Ischemic Preconditioning on Mortality and Morbidity in Cardiac Surgery: a Randomized Controlled Trial

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00997217
Acronym
RIPC
Enrollment
1200
Registered
2009-10-19
Start date
2009-10-31
Completion date
2010-11-30
Last updated
2011-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Surgical Procedures, Myocardium; Injury

Keywords

RIPC, cardiac surgery, ischemic preconditioning, cardiac surgical procedures

Brief summary

Perioperative myocardial injury is a serious complication of cardiac surgery. This complication increases both mortality and morbidity of cardiac surgery. Remote ischemic preconditioning (RIPC) is the concept that brief ischemia followed by reperfusion in an organ can reduce subsequent ischemia-reperfusion injury in distant organs. Recent several clinical trials showed powerful myocardial protective effect of remote ischemic preconditioning by reducing postoperative cardiac enzymes. However, the evidence that remote ischemic preconditioning can improve the clinical outcomes such as mortality and morbidity, is still lacking. The investigators perform a multicenter randomized controlled study to evaluate that remote ischemic preconditioning can improve the outcomes of cardiac surgery.

Detailed description

Perioperative myocardial injury is a serious complication of cardiac surgery. This complication increases both mortality and morbidity of cardiac surgery. Remote ischemic preconditioning (RIPC) is the concept that brief ischemia followed by reperfusion in an organ can reduce subsequent ischemia-reperfusion injury in distant organs. Recent several clinical trials showed powerful myocardial protective effect of remote ischemic preconditioning by reducing postoperative cardiac enzymes. However, the evidence that remote ischemic preconditioning can improve the clinical outcomes such as mortality and morbidity, is still lacking. The investigators perform a multicenter randomized controlled study to evaluate that remote ischemic preconditioning can improve the outcomes of cardiac surgery. Purpose: The purpose of this study is to examine if remote ischemic preconditioning can decrease the mortality and fatal postoperative complications in patients undergoing cardiac surgery. The effect will be assessed by mortality, severe morbidities and duration of hospital stay. Methods: Study patients will be randomized to cardiac surgery with RIPC or conventional cardiac surgery in two cardiac surgical centers (Seoul National University Hospital and Asan Medical Center). Remote ischemic preconditioning consists of four 5 min cycles of upper limb ischemia and reperfusion with pneumatic cuff up to 200 mmHg. RIPC is performed twice: before and after the coronary anastomosis in off-pump coronary bypass graft surgery; or before and after the cardiopulmonary bypass in the cardiac valve surgery. Primary study outcome is in-hospital death within 30 postoperative days and fatal postoperative complications such as myocardial infarction, stoke, respiratory failure, renal failure, cardiogenic shock and gastrointestinal complications. Secondary outcomes include the length of intensive care unit (ICU) stay and hospital stay.

Interventions

PROCEDUREremote ischemic preconditioning

remote ischemic preconditioning (4 x 5 min upper limb ischemia with pneumatic cuff up to 200 mmHg with an intervening 5 min reperfusion; 2 cycles; before and after the coronary anastomosis or cardiopulmonary bypass)

Sponsors

Asan Medical Center
CollaboratorOTHER
Seoul National University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* adult patients undergoing cardiac surgery

Exclusion criteria

* emergent operation * preoperative use of inotropics or mechanical assist device, * left ventricular ejection fraction less than 30%, * severe liver, renal and pulmonary disease, * recent myocardial infarction (within 7 days), * recent systemic infection or sepsis (within 7 days) * peripheral vascular disease affecting upper limbs * amputation of the upper limbs * major combined operation such as aortic surgery or carotid endarterectomy * descending thoracic aortic surgery * rare surgeries; cardiac transplantation, correction of complicated congenital anomalies, pulmonary thromboembolectomy, etc

Design outcomes

Primary

MeasureTime frame
Gastrointestinal complicationPostoperative 30 days
Renal failurePostoperative 30 days
Cardiogenic shockPostoperative 30 days
In-hospital deathPostoperative 30 days
Myocardial infarctionPostoperative 30 days
StrokePostoperative 30 days
Respiratory failurePostoperative 30 days
Renal dysfunctionPostoperative 30 days

Secondary

MeasureTime frame
Length of postoperative hospital stayPostoperative 3 months
Length of ICU stayPostoperative 3 months

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 11, 2026