The Effect of Remote Ischemic Preconditioning in the Cardiac Surgery

Cardiac Surgical Procedures Clinical Trial

— RIPC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00997217
• Other study ID #: RIPCmulticenter
• Status: Completed
• Phase: Phase 1
• First received: October 15, 2009
• Last updated: February 22, 2011
• Start date: October 2009
• Est. completion date: November 2010

Study information

• Verified date: February 2011
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1200
• Est. completion date: November 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cardiac Surgical Procedures
• Myocardium; Injury

Intervention

Procedure:
• remote 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)

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	In-hospital death		Postoperative 30 days	Yes
Primary	Myocardial infarction		Postoperative 30 days	Yes
Primary	Stroke		Postoperative 30 days	Yes
Primary	Respiratory failure		Postoperative 30 days	Yes
Primary	Renal dysfunction		Postoperative 30 days	Yes
Primary	Renal failure		Postoperative 30 days	Yes
Primary	Cardiogenic shock		Postoperative 30 days	Yes
Primary	Gastrointestinal complication		Postoperative 30 days	Yes
Secondary	Length of ICU stay		Postoperative 3 months	Yes
Secondary	Length of postoperative hospital stay		Postoperative 3 months	Yes