Renal Effects of RIPC in Patients After Total Arch Replacement

Not Applicable

Completed

• Conditions: Acute Kidney Injury; Dialysis
• Interventions: Other: Control; Other: remote ischemic preconditioning

• Registration Number: NCT03141385
• Lead Sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2017-04-07
• Study First Submitted: 2017-05-03
• Study First Submitted QC: 2017-05-03
• Study First Posted: 2017-05-05
• Primary Completion: 2018-05-01
• Study Completion: 2018-05-30
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-10
• Last Update Posted: 2018-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Control	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.
RIPC intervention	remote ischemic preconditioning	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)

Primary Outcome Measures

Name	Time	Method
Incidence of AKI within the 7 days after the surgery	Within 7 days after the surgery	AKI defined by KDIGO criteria

Secondary Outcome Measures

Name	Time	Method
In-hospital death	Within 30 days after the surgery	in-hospital all-cause death
Stroke	Within 30 days after the surgery	new onset stroke during index hospital stay
Renal replacement therapy	Within 30 days after the surgery	the requirement for RRT during index hospital stay
Length of intensive care unit stay	Within 30 days after the surgery	length of stay on the intensive care unit
Incidence of severe AKI (stage 2 and stage 3)	Within 7 days after the surgery	severity defined by KDIGO criteria
Paraplegia	Within 30 days after the surgery	impairment in motor or sensory function of the lower extremities during index hospital stay
Mechanical ventilation duration	Within 30 days after the surgery	duration of mechanical ventilation in the intensive care unit

Trial Locations

Locations (1)

State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, CAMS and PUMC; 🇨🇳 Beijing, China