Renal Effects of RIPC in Patients After Total Arch Replacement (RenRIPC-TAR)

Chinese Academy of Medical Sciences, Fuwai Hospital

Status: Completed

Conditions: Dialysis; Acute Kidney Injury

Treatments: Other: Control; Other: remote ischemic preconditioning

Study type: Interventional

Funder types: Other

Identifiers

NCT03141385

FW2016-F09

Details and patient eligibility

About

The purpose of this study is to test the hypothesis that remote ischemic preconditioning prevents acute kidney injury and improves clinical outcomes in patients undergoing total arch replacement.

Full description

Acute kidney injury (AKI) is a well-recognized complication after cardio-thoracic surgeries and is associated with increased morbidity and mortality. Total arch replacement is reported with a relatively high incidence of post-operative AKI. In addition, few effective preventive or therapeutic interventions for AKI have been identified. A number of studies have now addressed renal protection as a primary outcome following RIPC. Because the mechanism of I/R injury are similar to those proposed for AKI after CPB, the purpose of this study is to test the hypothesis that remote ischemic preconditioning prevents acute kidney injury and improves clinical outcomes in patients undergoing total arch replacement.

Enrollment: 130 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients scheduled for total arch replacement
• written informed consent

Exclusion criteria

• pre-existing AKI
• peripheral vascular disease affecting the upper limbs
• hybrid total arch replacement
• the history of kidney transplantation

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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130 participants in 2 patient groups

RIPC intervention

Experimental group

Description:

Remote ischemic preconditioning (RIPC) will be induced after the general anesthesia prior to the cardiopulmonary bypass by four cycles of right limber ischemia (5-min blood pressure cuff inflation to a pressure of 200mmHg or a pressure that is 50 mmHg higher than SAP and 5-min cuff deflation)

Treatment:

Other: remote ischemic preconditioning

Control

Sham Comparator group

Description:

Four cycles of right upper limb pseudo ischemia and reperfusion, which will be induced by 5-minute blood pressure cuff inflation to a low pressure of 20 mmHg followed by 5-minute cuff deflated.

Treatment:

Other: Control