Back to resultsCardiopulmonary Protective Effects of Modified Remote Ischaemic Preconditioning in Mitral Valve Replacement Surgery
Primary Purpose
Myocardial Injury, Remote Ischemic Preconditioning
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Modified Remote Ischemic Preconditioning
Control
Sponsored by
About this trial
This is an interventional prevention trial for Myocardial 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
- 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)
- Recent systemic infection or sepsis (within 7 days)
- Severe stroke (within 2 months)
- Significant peripheral arterial disease affecting the upper limbs
- Previous serious psychiatric disorders (e.g. schizophrenia, dementia)
- Surgeries: cardiac transplantation, concomitant carotid endarterectomy , previous heart surgery,off-pump surgery, emergency surgery
Sites / Locations
- The Affiliated Hospital of Xuzhou Medical University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Modified Remote Ischemic Preconditioning(mRIPC)
Control
Arm 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.
Control group without remote ischemic preconditioning
Outcomes
Primary Outcome Measures
Troponin I serum release over 24 hours after surgery
Secondary Outcome Measures
PaO2/FiO2 ratio over 24 hours after surgery
salveolar-arterial oxygen gradient over 24 hours after surgery
Inotrope score
Full Information
NCT ID
NCT03010839
First Posted
December 31, 2016
Last Updated
March 15, 2018
Sponsor
Xuzhou Medical University
1. Study Identification
Unique Protocol Identification Number
NCT03010839
Brief Title
Cardiopulmonary Protective Effects of Modified Remote Ischaemic Preconditioning in Mitral Valve Replacement Surgery
Official Title
Cardiopulmonary Protection of Modified Remote Ischaemic Preconditioning in Mitral Valve Replacement Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
November 5, 2016 (Actual)
Primary Completion Date
January 10, 2018 (Actual)
Study Completion Date
March 10, 2018 (Actual)
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 , 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Injury, Remote Ischemic Preconditioning
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
86 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Modified Remote Ischemic Preconditioning(mRIPC)
Arm Type
Active Comparator
Arm 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.
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Control group without remote ischemic preconditioning
Intervention Type
Procedure
Intervention Name(s)
Modified Remote Ischemic Preconditioning
Other Intervention Name(s)
mRIPC
Intervention Description
mRIPC will be induced at 24 h, 12 h and 1 h before surgery and once before induction of 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
Troponin I serum release over 24 hours after surgery
Time Frame
24 hours post surgery
Secondary Outcome Measure Information:
Title
PaO2/FiO2 ratio over 24 hours after surgery
Time Frame
24 hours post surgery
Title
salveolar-arterial oxygen gradient over 24 hours after surgery
Time Frame
24 hours post surgery
Title
Inotrope score
Time Frame
12 hours 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
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)
Recent systemic infection or sepsis (within 7 days)
Severe stroke (within 2 months)
Significant peripheral arterial disease affecting the upper limbs
Previous serious psychiatric disorders (e.g. schizophrenia, dementia)
Surgeries: cardiac transplantation, concomitant carotid endarterectomy , previous heart surgery,off-pump surgery, emergency surgery
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
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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Cardiopulmonary Protective Effects of Modified Remote Ischaemic Preconditioning in Mitral Valve Replacement Surgery
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