Remote Ischemic Preconditioning on Pulmonary Injury in Cardic Surgery

Not Applicable

• Conditions: Remote Ischemic Preconditioning; Lung Injury
• Interventions: Procedure: Control; Procedure: Remote Ischemic Preconditioning

• Registration Number: NCT03016182
• Lead Sponsor: 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.

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 Timeline

• Status Verified: 2017-01
• Study First Submitted: 2017-01-07
• Study First Submitted QC: 2017-01-07
• Study First Posted: 2017-01-10
• Study Start: 2017-02-07
• Last Update Submitted: 2017-02-19
• Last Update Posted: 2017-02-23
• Primary Completion: 2018-02
• Study Completion: 2018-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Control	Control group without remote ischemic preconditioning
Remote Ischemic Preconditioning(RIPC)	Remote Ischemic Preconditioning	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

Primary Outcome Measures

Name	Time	Method
Comparison of PaO2/FiO2 over 24 hours after cardiac surgery	24 hours post surgery

Secondary Outcome Measures

Name	Time	Method
All-cause mortality	30 days post surgery
Postoperative Pulmonary Complications	30 days post surgery

Trial Locations

Locations (1)

The Affiliated Hospital of Xuzhou Medical University; 🇨🇳 Xuzhou, Jiangsu, China