Congenital Heart DiseaseSCRIPTNCT01260259
Seattle Cardiorenal Remote Ischemic Preconditioning Trial
A study testing RIPC in people with Congenital Heart Disease and Cardiopulmonary Bypass, run by Seattle Children's Hospital at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Congenital Heart Disease, Cardiopulmonary Bypass, Myocardial Injury
- What is being tested?
- RIPC
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2010to Aug 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age birth to 18 years Cardiac surgery with planned cardiopulmonary bypass
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Seattle Children's Hospital
Seattle, Washington, 98105
About this study
Official title: Effect of Remote Ischemic Preconditioning in Children Undergoing Cardiac Surgery
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.
Read the 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.
- Conditions
- Congenital Heart Disease, Cardiopulmonary Bypass, Myocardial Injury, Acute Kidney Injury, Acute Lung Injury
- Being tested
- RIPC, Control
- Keywords
- Pediatric, Cardiac, Surgery, Cardiopulmonary, Bypass, Myocardial, Kidney, Lung, Injury
- Medical subject headings
- Heart Defects, Congenital, Acute Kidney Injury, Acute Lung Injury, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RIPCProcedure or surgery
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.
ControlProcedure or surgery
In OR, after induction of general anesthesia and arterial line placement, a deflated tourniquet will be placed over the lower extremity for 40 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Remote Ischemic Preconditioning (RIPC) | Experimental | Not described Receives: Procedure: RIPC |
| Control | Sham comparator | Not described Receives: Procedure: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of acute kidney injury (AKI)
Serum creatinine (SCr) will be measured at baseline, then on post-operative days 1, 2, and 3.
Measured: 72 hours
Incidence of acute myocardial injury
Troponin-I will be measured at baseline, then 6, 12, 24, and 48 hours post-operative.
Measured: 48 hours
Secondary outcomes (5)
Incidence of acute lung injury
Days on mechanical ventilation, readiness for extubation.
Measured: 72 hours and duration of hospitalization
Hospitalization
Number of post-operative days in cardiac intensive care unit (CICU) and hospital.
Measured: Duration of post-operative hospitalization
Mortality
Measured: Duration of hospitalization, 30 days post-op, and at last follow-up
Biomarkers for AKI
Serum and urine will be collected for biomarker discovery.
Measured: 72 hours
Inflammation
Cytokines will be measured at baseline until 72 hours post-operative.
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2010 (estimated)
- Study startDec 2010
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seattle Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christine Hsu, Seattle Children's Hospital
- Investigators
- Christine W Hsu, MD, Principal investigator, Seattle Children's Hospital and University of WashingtonYuk Law, MD, Principal investigator, Seattle Children's Hospital and University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01260259
- Sponsor's protocol ID
- CCTR-3953179
- Acronym
- SCRIPT
- Status last verified
- Sep 2013
- First submitted
- 13 Dec 2010
- Last updated
- 18 Sep 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Law YM, Hsu C, Hingorani SR, Richards M, McMullan DM, Jefferies H, Himmelfarb J, Katz R. Randomized controlled trial of remote ischemic preconditioning in children having cardiac surgery. J Cardiothorac Surg. 2024 Jan 3;19(1):5. doi: 10.1186/s13019-023-02450-8.
PubMed 38172875
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Remote Ischemic Preconditioning in Children Undergoing Cardiac Surgery
- ClinicalTrials.gov ID
- NCT01260259
- Acronym / sponsor ID
- SCRIPT / CCTR-3953179
- Conditions
- Congenital Heart Disease, Cardiopulmonary Bypass, Myocardial Injury, Acute Kidney Injury, Acute Lung Injury
- Keywords
- Pediatric, Cardiac, Surgery, Cardiopulmonary, Bypass, Myocardial, Kidney, Lung
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Seattle Children's HospitalUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 15 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Remote Ischemic Preconditioning (RIPC) | Experimental | Procedure: RIPC |
| Control | Sham comparator | Procedure: Control |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Age birth to 18 years Cardiac surgery with planned cardiopulmonary bypass
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RIPCRIPC 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. | Procedure or surgery | Remote Ischemic Preconditioning (RIPC) |
| ControlIn OR, after induction of general anesthesia and arterial line placement, a deflated tourniquet will be placed over the lower extremity for 40 minutes. | Procedure or surgery | Control |
Primary outcome
Incidence of acute kidney injury (AKI)
Time frame: 72 hours
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
Troponin-I will be measured at baseline, then 6, 12, 24, and 48 hours post-operative.
5 secondary outcomes
Incidence of acute lung injury
Time frame: 72 hours and duration of hospitalization
Hospitalization
Time frame: Duration of post-operative hospitalization
Mortality
Time frame: Duration of hospitalization, 30 days post-op, and at last follow-up
Biomarkers for AKI
Time frame: 72 hours
Inflammation
Time frame: 72 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2013.
- Derived from this study: PubMed 38172875Law YM, Hsu C, Hingorani SR, Richards M, McMullan DM, Jefferies H, Himmelfarb J, Katz R. Randomized controlled trial of remote ischemic preconditioning in children having cardiac surgery. J Cardiothorac Surg. 2024 Jan 3;19(1):5. doi: 10.1186/s13019-023-02450-8.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christine W Hsu, MD principal investigator
Seattle Children's Hospital and University of Washington
Yuk Law, MD principal investigator
Seattle Children's Hospital and University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RIPC in people with Congenital Heart Disease and Cardiopulmonary Bypass, run by Seattle Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of acute kidney injury (AKI) (time frame: 72 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01260259, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2013.