NCT00997217

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,200

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Oct 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

October 15, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 19, 2009

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
Last Updated

February 24, 2011

Status Verified

February 1, 2011

Enrollment Period

11 months

First QC Date

October 15, 2009

Last Update Submit

February 22, 2011

Conditions

Myocardium; InjuryCardiac Surgical Procedures

Keywords

RIPCcardiac surgeryischemic preconditioningcardiac surgical procedures

Outcome Measures

Primary Outcomes (8)

  • In-hospital death

    Postoperative 30 days

  • Myocardial infarction

    Postoperative 30 days

  • Stroke

    Postoperative 30 days

  • Respiratory failure

    Postoperative 30 days

  • Renal dysfunction

    Postoperative 30 days

  • Renal failure

    Postoperative 30 days

  • Cardiogenic shock

    Postoperative 30 days

  • Gastrointestinal complication

    Postoperative 30 days

Secondary Outcomes (2)

  • Length of ICU stay

    Postoperative 3 months

  • Length of postoperative hospital stay

    Postoperative 3 months

Interventions

remote ischemic preconditioningPROCEDURE

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)

Also known as: Blood pressure pneumatic cuff

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adult patients undergoing cardiac surgery

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

Related Publications (2)

  • Cho YJ, Lee EH, Lee K, Kim TK, Hong DM, Chin JH, Choi DK, Bahk JH, Sim JY, Choi IC, Jeon Y. Long-term clinical outcomes of Remote Ischemic Preconditioning and Postconditioning Outcome (RISPO) trial in patients undergoing cardiac surgery. Int J Cardiol. 2017 Mar 15;231:84-89. doi: 10.1016/j.ijcard.2016.12.146. Epub 2016 Dec 23.

    PMID: 28043669DERIVED

  • Hong DM, Lee EH, Kim HJ, Min JJ, Chin JH, Choi DK, Bahk JH, Sim JY, Choi IC, Jeon Y. Does remote ischaemic preconditioning with postconditioning improve clinical outcomes of patients undergoing cardiac surgery? Remote Ischaemic Preconditioning with Postconditioning Outcome Trial. Eur Heart J. 2014 Jan;35(3):176-83. doi: 10.1093/eurheartj/eht346. Epub 2013 Sep 7.

    PMID: 24014392DERIVED

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

  • YunSeok Jeon, professor

    Department of Anesthesiology and Pain Medicine, SNUH

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 15, 2009

First Posted

October 19, 2009

Study Start

October 1, 2009

Primary Completion

September 1, 2010

Study Completion

November 1, 2010

Last Updated

February 24, 2011

Record last verified: 2011-02

Locations

KR(1)