Renal Effects of RIPC in Patients After Total Arch Replacement

Acute Kidney Injury Clinical Trial

— RenRIPC-TAR  

Official title:

Renal Effects of Remote Ischemic Preconditioning in Patients After Total Arch Replacement

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03141385
• Other study ID #: FW2016-F09
• Status: Completed
• Phase: N/A
• Start date: April 7, 2017
• Est. completion date: May 30, 2018

Study information

• Verified date: July 2018
• Source: Chinese Academy of Medical Sciences, Fuwai Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: May 30, 2018
• Est. primary completion date: May 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury
• Dialysis

Intervention

Other:
• 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)
• 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.

Locations

Country	Name	City	State
China	State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, CAMS and PUMC	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese Academy of Medical Sciences, Fuwai Hospital

Country where clinical trial is conducted

China, 

Outcome

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