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Trial record 36 of 67 for:    Recruiting, Not yet recruiting, Available Studies | "Thoracic Injuries"

Remote Ischemic Preconditioning on Pulmonary Injury in Cardic Surgery

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ClinicalTrials.gov Identifier: NCT03016182
Recruitment Status : Recruiting
First Posted : January 10, 2017
Last Update Posted : February 23, 2017
Sponsor:
Information provided by (Responsible Party):
Su Liu, Xuzhou Medical University

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.


Condition or disease Intervention/treatment Phase
Lung Injury Remote Ischemic Preconditioning Procedure: Remote Ischemic Preconditioning Procedure: Control Not Applicable

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Effect of Remote Ischemic Preconditioning on Pulmonary Injury in Cardic Surgery
Actual Study Start Date : February 7, 2017
Estimated Primary Completion Date : February 2018
Estimated Study Completion Date : February 2018

Arm Intervention/treatment
Active Comparator: Remote Ischemic Preconditioning(RIPC)
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
Procedure: Remote Ischemic Preconditioning
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
Other Name: RIPC

Placebo Comparator: Control
Control group without remote ischemic preconditioning
Procedure: Control
Control group witnout remote ischemic preconditioning




Primary Outcome Measures :
  1. Comparison of PaO2/FiO2 over 24 hours after cardiac surgery [ Time Frame: 24 hours post surgery ]

Secondary Outcome Measures :
  1. All-cause mortality [ Time Frame: 30 days post surgery ]
  2. Postoperative Pulmonary Complications [ Time Frame: 30 days post surgery ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients undergoing heart surgery on cardiopulmonary bypass
  2. Patients aged 18 years to 80 years

Exclusion Criteria:

  1. Inability to give informed consent
  2. Preoperative severe impairment of respiratory function (arterial oxygen tension (PaO2) <60 mmHg or FEV1<50% predicted)
  3. Prior receipt of chemotherapy or radiation therapy or immunotherapy
  4. left ventricular ejection fraction less than 30%
  5. preoperative use of inotropics or mechanical assist device
  6. Patients with significant hepatic dysfunction (Prothrombin>2.0 ratio)
  7. Patients with known renal failure with a GFR<30 mL/min/1.73 m2
  8. recent myocardial infarction (within 7 days)
  9. 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℃)
  10. Significant peripheral arterial disease affecting the upper limbs
  11. surgeries: cardiac transplantation, concomitant carotid endarterectomy , previous heart surgery,, off-pump surgery, emergency surgery

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03016182


Contacts
Contact: Liu Su, M.D/Ph.D +86-18118309692 xyfymzk@163.com

Locations
China, Jiangsu
The Affiliated Hospital of Xuzhou Medical University Recruiting
Xuzhou, Jiangsu, China
Sponsors and Collaborators
Xuzhou Medical University
Investigators
Principal Investigator: Liu Su, M.D/Ph.D The Affiliated Hospital of Xuzhou Medical University

Publications of Results:

Responsible Party: Su Liu, Principal Investigator, Xuzhou Medical University
ClinicalTrials.gov Identifier: NCT03016182     History of Changes
Other Study ID Numbers: XYFY-2017-004
First Posted: January 10, 2017    Key Record Dates
Last Update Posted: February 23, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: IPD will be available when this trial is finished and the article have been published.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Wounds and Injuries
Ischemia
Lung Injury
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Thoracic Injuries