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Clinical Trials/NCT03016182
NCT03016182
Unknown
N/A

Effect of Remote Ischemic Preconditioning on Pulmonary Injury in Cardic Surgery

Xuzhou Medical University1 site in 1 country60 target enrollmentFebruary 7, 2017

Overview

Phase
N/A
Intervention
Not specified
Conditions
Lung Injury
Sponsor
Xuzhou Medical University
Enrollment
60
Locations
1
Primary Endpoint
Comparison of PaO2/FiO2 over 24 hours after cardiac surgery
Last Updated
9 years ago

Overview

Brief Summary

During cardiac surgery with cardiopulmonary bypass , pulmonary dysfunction remains to be a problem complicating the postoperative course of the patients.Remote ischemic preconditioning(RIPC) with transient upper limb ischemia/reperfusion is a novel, simple, cost-free,non-pharmacological and non-invasive strategy.Recent several trials suggested that RIPC could provide pulmonary protection by reducing serum biomarkers,however,whether the RIPC can improve the clinical outcomes in patients undergoing on-pump cardiac surgery,is still uncertain.

The study hypothesis is: remote ischemic preconditioning will provide lung-protective effect and improve clinical outcomes in patients undergoing cardic surgery.

Detailed Description

Remote ischemic preconditioning (RIPC) protocol will be induced during anesthesia by 3 cycles of 5-min upper limb ischemia and 5-min reperfusion using a blood pressure cuff inflated to a pressure 200mmHg

Registry
clinicaltrials.gov
Start Date
February 7, 2017
End Date
February 2018
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Xuzhou Medical University
Responsible Party
Principal Investigator
Principal Investigator

Su Liu

Principal Investigator

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
  • Preoperative severe impairment of respiratory function (arterial oxygen tension (PaO2) \<60 mmHg or FEV1\<50% predicted)
  • Prior receipt of chemotherapy or radiation therapy or immunotherapy
  • left ventricular ejection fraction less than 30%
  • 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
  • recent myocardial infarction (within 7 days)
  • Systemic or local active infections (either clinically defined or suggested by evidence such as elevated C-reactive protein levels, leukocytosis, or a body temperature\>38℃)
  • Significant peripheral arterial disease affecting the upper limbs

Outcomes

Primary Outcomes

Comparison of PaO2/FiO2 over 24 hours after cardiac surgery

Time Frame: 24 hours post surgery

Secondary Outcomes

  • All-cause mortality(30 days post surgery)
  • Postoperative Pulmonary Complications(30 days post surgery)

Study Sites (1)

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