Seattle Cardiorenal Remote Ischemic Preconditioning Trial

Acute Kidney Injury Clinical Trial

— SCRIPT  

Official title:

Effect of Remote Ischemic Preconditioning in Children Undergoing Cardiac Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01260259
• Other study ID #: CCTR-3953179
• Status: Completed
• Phase: N/A
• First received: December 13, 2010
• Last updated: September 16, 2013
• Start date: December 2010
• Est. completion date: August 2013

Study information

• Verified date: September 2013
• Source: Seattle Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Remote Ischemic Preconditioning (RIPC) is a treatment that may be associated with improved outcomes after cardiac surgery. It can be elicited noninvasively by using a tourniquet to elicit transient ischemia over a lower extremity. It is thought to promote anti-inflammatory and cell survival pathways, and thus protect remote organs against future ischemic injury. We hypothesize that compared to sham treatment, RIPC will be associated with decreased post-operative acute kidney, myocardial, and lung injury.

Description:

In children undergoing cardiac surgery and cardiopulmonary bypass (CPB), our primary aims are to determine whether RPC is associated with: 1) decreased AKI and 2) decreased acute myocardial injury. Secondary aims include investigating the effects of RPC on post-procedure: 1)acute lung injury and 2) morbidity/mortality.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 18 Years

Eligibility

Inclusion Criteria:

Age birth to 18 years Cardiac surgery with planned cardiopulmonary bypass

Exclusion Criteria:

Any contraindication to compression of lower extremity/extremities Body weight <2 kg Active infection going into surgery On renal replacement therapy (RRT) or mechanical circulatory support going into surgery On inotropic support going into surgery

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Acute Kidney Injury
• Acute Lung Injury
• Cardiopulmonary Bypass
• Congenital Heart Disease
• Heart Defects, Congenital
• Lung Injury
• Myocardial Injury
• Respiratory Distress Syndrome, Adult

Intervention

Procedure:
• RIPC
RIPC will be elicited in the operating room (OR) after anesthesia induction and before start of surgery. After placement of an arterial line, a tourniquet will be placed over a lower extremity. It will be inflated to 15 mmHg above systolic blood pressure for 5 minutes, and then deflated for 5 minutes. This cycle of inflation-deflation will be repeated another 3 times before surgery.
• Control
In OR, after induction of general anesthesia and arterial line placement, a deflated tourniquet will be placed over the lower extremity for 40 minutes.

Locations

Country	Name	City	State
United States	Seattle Children's Hospital	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Seattle Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of acute kidney injury (AKI)	Serum creatinine (SCr) will be measured at baseline, then on post-operative days 1, 2, and 3.	72 hours	Yes
Primary	Incidence of acute myocardial injury	Troponin-I will be measured at baseline, then 6, 12, 24, and 48 hours post-operative.	48 hours	Yes
Secondary	Incidence of acute lung injury	Days on mechanical ventilation, readiness for extubation.	72 hours and duration of hospitalization	Yes
Secondary	Hospitalization	Number of post-operative days in cardiac intensive care unit (CICU) and hospital.	Duration of post-operative hospitalization	Yes
Secondary	Mortality		Duration of hospitalization, 30 days post-op, and at last follow-up	Yes
Secondary	Biomarkers for AKI	Serum and urine will be collected for biomarker discovery.	72 hours	No
Secondary	Inflammation	Cytokines will be measured at baseline until 72 hours post-operative.	72 hours	No