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Clinical Trials/NCT03010839
NCT03010839
Completed
N/A

Cardiopulmonary Protection of Modified Remote Ischaemic Preconditioning in Mitral Valve Replacement Surgery

Xuzhou Medical University1 site in 1 country86 target enrollmentNovember 5, 2016

Overview

Phase
N/A
Intervention
Not specified
Conditions
Myocardial Injury
Sponsor
Xuzhou Medical University
Enrollment
86
Locations
1
Primary Endpoint
Troponin I serum release over 24 hours after surgery
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

During cardiac surgery with cardiopulmonary bypass , injury occurs to the heart muscle and the lung.The heart and lung injury is a serious complication ,which increases both mortality and morbidity of cardiac surgery .Remote ischemic preconditioning(RIPC) with transient upper limb ischemia/reperfusion is a novel, simple, cost-free,non-pharmacological and non-invasive strategy.Recent some trials suggested that RIPC could provide myocardial protection by reducing serum cardiac biomarkers,however, more recent multicenter studies[9-11] had failed to show the protective effects of RIPC with respect to the troponin release and lung injury.

Remote ischemic preconditioning (RIPC) is reported to have the early-phase and delayed-phase organ protective effects, whether the modified RIPC protocol induced repeatedly has the cardiopulmonary protective effect is still uncertain.

Detailed Description

modified RIPC was induced at 24 h, 12 h and 1 h before surgery to reinforce the protective effects of RIPC.The single RIPC protocol was induced by three cycles of upper-limb ischemia, a standard blood-pressure cuff was placed on the ringt upper arm, then inflated the cuff to 200 mm Hg for 5 minutes, followed by 5 min of cuff deflation.

Registry
clinicaltrials.gov
Start Date
November 5, 2016
End Date
March 10, 2018
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Xuzhou Medical University
Responsible Party
Principal Investigator
Principal Investigator

Su Liu

M.D/Ph.D

Xuzhou Medical University

Eligibility Criteria

Inclusion Criteria

  • Patients undergoing heart surgery on cardiopulmonary bypass
  • Patients aged 18 years to 80 years

Exclusion Criteria

  • Inability to give informed consent
  • Cardiogenic shock
  • Cardiac arrest on current admission
  • Left ventricular ejection fraction less than 30%
  • Current atrial fibrillation
  • Preoperative use of inotropics or mechanical assist device
  • Patients with significant hepatic dysfunction (Prothrombin\>2.0 ratio)
  • Patients with known renal failure with a GFR\<30 mL/min/1.73 m2
  • Patients with significant pulmonary disease (FEV1\<40% predicted)
  • Recent myocardial infarction (within 7 days)

Outcomes

Primary Outcomes

Troponin I serum release over 24 hours after surgery

Time Frame: 24 hours post surgery

Secondary Outcomes

  • salveolar-arterial oxygen gradient over 24 hours after surgery(24 hours post surgery)
  • PaO2/FiO2 ratio over 24 hours after surgery(24 hours post surgery)
  • Inotrope score(12 hours post surgery)

Study Sites (1)

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