Seattle Cardiorenal Remote Ischemic Preconditioning Trial (SCRIPT)
This study is currently recruiting participants.
Verified January 2013 by Seattle Children's Hospital
Sponsor:
Seattle Children's Hospital
Information provided by (Responsible Party):
Christine Hsu, Seattle Children's Hospital
ClinicalTrials.gov Identifier:
NCT01260259
First received: December 13, 2010
Last updated: January 15, 2013
Last verified: January 2013
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Congenital Heart Disease Cardiopulmonary Bypass Myocardial Injury Acute Kidney Injury Acute Lung Injury |
Procedure: RIPC Procedure: Control |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | Effect of Remote Ischemic Preconditioning in Children Undergoing Cardiac Surgery |
Resource links provided by NLM:
Further study details as provided by Seattle Children's Hospital:
Primary Outcome Measures:
- Incidence of acute kidney injury (AKI) [ Time Frame: 72 hours ] [ Designated as safety issue: Yes ]Serum creatinine (SCr) will be measured at baseline, then on post-operative days 1, 2, and 3.
- Incidence of acute myocardial injury [ Time Frame: 48 hours ] [ Designated as safety issue: Yes ]Troponin-I will be measured at baseline, then 6, 12, 24, and 48 hours post-operative.
Secondary Outcome Measures:
- Incidence of acute lung injury [ Time Frame: 72 hours ] [ Designated as safety issue: Yes ]Days on mechanical ventilation, readiness for extubation.
- Hospitalization [ Time Frame: Duration of post-operative hospitalization ] [ Designated as safety issue: Yes ]Number of post-operative days in cardiac intensive care unit (CICU) and hospital.
- Mortality [ Time Frame: Duration of hospitalization ] [ Designated as safety issue: Yes ]
- Biomarkers for AKI [ Time Frame: 72 hours ] [ Designated as safety issue: No ]Serum and urine will be collected for biomarker discovery.
- Inflammation [ Time Frame: 72 hours ] [ Designated as safety issue: No ]Cytokines will be measured at baseline until 72 hours post-operative.
| Estimated Enrollment: | 100 |
| Study Start Date: | December 2010 |
| Estimated Study Completion Date: | June 2014 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Remote Ischemic Preconditioning (RIPC) |
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.
|
| Sham Comparator: Control |
Procedure: 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.
|
Detailed 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.
Eligibility| Ages Eligible for Study: | up to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01260259
Contacts
| Contact: Christine W Hsu, MD | 206-987-2524 | christine.hsu@seattlechildrens.org |
| Contact: Yuk Law, MD | 206-987-5607 | yuk.law@seattlechildrens.org |
Locations
| United States, Washington | |
| Seattle Children's Hospital | Recruiting |
| Seattle, Washington, United States, 98105 | |
| Contact: Christine W Hsu, MD, MS 206-543-2346 cwhsu8@uw.edu | |
| Contact: Yuk Law, MD 206-987-5607 yuk.law@seattlechildrens.org | |
| Principal Investigator: Christine W Hsu, MD | |
| Principal Investigator: Yuk Law, MD | |
Sponsors and Collaborators
Seattle Children's Hospital
Investigators
| Principal Investigator: | Christine W Hsu, MD | Seattle Children's Hospital and University of Washington |
| Principal Investigator: | Yuk Law, MD | Seattle Children's Hospital and University of Washington |
More Information
No publications provided
| Responsible Party: | Christine Hsu, Principal Investigator, Seattle Children's Hospital |
| ClinicalTrials.gov Identifier: | NCT01260259 History of Changes |
| Other Study ID Numbers: | CCTR-3953179 |
| Study First Received: | December 13, 2010 |
| Last Updated: | January 15, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Seattle Children's Hospital:
|
Pediatric Cardiac Surgery Cardiopulmonary Bypass |
Myocardial Kidney Lung Injury |
Additional relevant MeSH terms:
|
Heart Diseases Acute Kidney Injury Heart Defects, Congenital Acute Lung Injury Respiratory Distress Syndrome, Adult Lung Injury Cardiovascular Diseases Renal Insufficiency Kidney Diseases |
Urologic Diseases Cardiovascular Abnormalities Congenital Abnormalities Lung Diseases Respiratory Tract Diseases Respiration Disorders Thoracic Injuries Wounds and Injuries |
ClinicalTrials.gov processed this record on May 23, 2013