Remote Ischemic Preconditioning on Pulmonary Injury in Cardic Surgery

Xuzhou Medical University

Status: Unknown

Conditions: Lung Injury; Remote Ischemic Preconditioning

Treatments: Procedure: Remote Ischemic Preconditioning; Procedure: Control

Study type: Interventional

Funder types: Other

Identifiers

NCT03016182

XYFY-2017-004

Details and patient eligibility

About

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.

Full 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

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups, including a placebo group

Remote Ischemic Preconditioning(RIPC)

Active Comparator group

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

Treatment:

Procedure: Remote Ischemic Preconditioning

Control

Placebo Comparator group

Description:

Control group without remote ischemic preconditioning

Treatment:

Procedure: Control