Back to resultsRemote Ischemic Preconditioning on Pulmonary Injury in Cardic Surgery
Primary Purpose
Lung Injury, Remote Ischemic Preconditioning
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Remote Ischemic Preconditioning
Control
Sponsored by
About this trial
This is an interventional prevention trial for Lung Injury
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
- surgeries: cardiac transplantation, concomitant carotid endarterectomy , previous heart surgery,, off-pump surgery, emergency surgery
Sites / Locations
- The Affiliated Hospital of Xuzhou Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Remote Ischemic Preconditioning(RIPC)
Control
Arm Description
3 cycles of 5-min upper limb ischemia and 5-min reperfusion using a blood-pressure cuff inflated to a pressure 200mmHg will be given to RIPC
Control group without remote ischemic preconditioning
Outcomes
Primary Outcome Measures
Comparison of PaO2/FiO2 over 24 hours after cardiac surgery
Secondary Outcome Measures
All-cause mortality
Postoperative Pulmonary Complications
Full Information
NCT ID
NCT03016182
First Posted
January 7, 2017
Last Updated
February 19, 2017
Sponsor
Xuzhou Medical University
1. Study Identification
Unique Protocol Identification Number
NCT03016182
Brief Title
Remote Ischemic Preconditioning on Pulmonary Injury in Cardic Surgery
Official Title
Effect of Remote Ischemic Preconditioning on Pulmonary Injury in Cardic Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Unknown status
Study Start Date
February 7, 2017 (Actual)
Primary Completion Date
February 2018 (Anticipated)
Study Completion Date
February 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Xuzhou Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Injury, Remote Ischemic Preconditioning
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Remote Ischemic Preconditioning(RIPC)
Arm Type
Active Comparator
Arm Description
3 cycles of 5-min upper limb ischemia and 5-min reperfusion using a blood-pressure cuff inflated to a pressure 200mmHg will be given to RIPC
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Control group without remote ischemic preconditioning
Intervention Type
Procedure
Intervention Name(s)
Remote Ischemic Preconditioning
Other Intervention Name(s)
RIPC
Intervention Description
RIPC 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
Intervention Type
Procedure
Intervention Name(s)
Control
Intervention Description
Control group witnout remote ischemic preconditioning
Primary Outcome Measure Information:
Title
Comparison of PaO2/FiO2 over 24 hours after cardiac surgery
Time Frame
24 hours post surgery
Secondary Outcome Measure Information:
Title
All-cause mortality
Time Frame
30 days post surgery
Title
Postoperative Pulmonary Complications
Time Frame
30 days post surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
surgeries: cardiac transplantation, concomitant carotid endarterectomy , previous heart surgery,, off-pump surgery, emergency surgery
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Liu Su, M.D/Ph.D
Phone
+86-18118309692
Email
xyfymzk@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liu Su, M.D/Ph.D
Organizational Affiliation
The Affiliated Hospital of Xuzhou Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Affiliated Hospital of Xuzhou Medical University
City
Xuzhou
State/Province
Jiangsu
Country
China
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
IPD will be available when this trial is finished and the article have been published.
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Remote Ischemic Preconditioning on Pulmonary Injury in Cardic Surgery
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