Ischaemic Reperfusion InjuryNCT01680601
Remote Ischaemic Preconditioning in Children Undergoing Cardiac Surgery
A study testing Remote ischaemic preconditioning (RIPC) in people with Ischaemic Reperfusion Injury, run by NHS Greater Glasgow and Clyde at 1 site in United Kingdom.
Trial summary
Surgical correction of congenital heart defects in children requires the utilization of cardiopulmonary bypass, a technique that temporarily substitutes heart and lung functions during surgery. During this process the patient´s circulation is controlled by a bypass machine which provides several functions: 1. Read more about this study
- Who is it for?
- Ages 2 days to 16 years
- Conditions the study is for
- Ischaemic Reperfusion Injury
- What is being tested?
- Remote ischaemic preconditioning (RIPC)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2013to Mar 2015
- 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 2 days to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children undergoing cardiac surgery for correction of congenital heart defects utilizing cardiopulmonary bypass and cold blood cardioplegia strategy of myocardial protection.
- Children whose parents understand the child's condition, the purpose of the study and are willing to participate.
Who cannot join
- Children whose parents either are unwilling or do not have sufficient understanding of the study.
- Emergency operations, where there is insufficient time to establish the study protocol.
- Premature children presenting a corrected gestational age under 35 weeks.
- Presence of extracardiac abnormalities, apart from cases of Down and DiGeorge syndromes which will be included.
- Patients with known viral blood infections (e.g. HIV, Hepatitis B) or severe congenital infection.
- Patients with severe preoperative brain injury.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Royal Hospital for Sick Children - Yorkhill
Glasgow, G3 8SJ
About this study
Official title: Effect of Remote Ischaemic Preconditioning in Cardiac Dysfunction and End-organ Injury Following Cardiac Surgery With Cardiopulmonary Bypass in Children.
Surgical correction of congenital heart defects in children requires the utilization of cardiopulmonary bypass, a technique that temporarily substitutes heart and lung functions during surgery. During this process the patient´s circulation is controlled by a bypass machine which provides several functions:
- Controls the patient's blood flow by pumping of blood in the patient's body.
- Controls the correct oxygen levels in the patient's blood.
- Regulates the temperature and fluid level of the blood. This process triggers negative responses in the heart and throughout the whole body, potentially resulting in injury to the heart and other organs such as brain, kidneys and lungs.
Read more
Remote ischaemic preconditioning (RIPC) describes a procedure that could potentially reduce the injury to heart muscle during cardiac surgery. The procedure consists of the inflation of a blood pressure cuff on the child's leg for three 5 minute cycles. This process acts by briefly reducing blood flow to the leg muscle, which will then activate the body´s own protective mechanisms and thereby reduce heart injury.
Several animal studies have been used to help the understanding of the mechanisms behind this process, and trials in human adults have showed optimistic results; however evidence regarding the paediatric population is limited and necessary since children present different basal profiles, risks and requirements.
The investigators propose a randomized clinical trial assessing the efficacy of RIPC to provide protection against injury to the heart and other organs in children going through cardiac surgery using CPB at the Royal Hospital for Sick Children. The research project will have a translational approach, integrating basic molecular mechanisms to clinical outcome. The investigators hope it will allow the understanding and utilisation of the patient´s own protective mechanisms, reducing CPB-related injury and ultimately improving patient outcome.
- Conditions
- Ischaemic Reperfusion Injury
- Being tested
- Remote ischaemic preconditioning (RIPC), Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote ischaemic preconditioning (RIPC)Procedure or surgery
RIPC will be performed by 3 cycles of 5 minute leg ischaemia induced by inflation of a blood pressure cuff to 40 mmHg above the patient's systolic pressure. This protocol will be performed at two phases: 24 hours before surgery and during anaesthesia immediately prior to surgery.
PlaceboProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| RIPC group | Experimental | Patients assigned to this arm will go through a remote ischaemic preconditioning (RIPC)protocol Receives: Procedure: Remote ischaemic preconditioning (RIPC) |
| Control | Placebo comparator | Patients assigned to this arm will not receive the intervention, however the protocol will be applied to a wooden block in order to maintain blinding to relatives and investigators. Receives: Procedure: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of the final cardiac injury after cardiopulmonary bypass assessed by markers of cardiac injury and echocardiography.
Echocardiography assessment will take place before surgery, 24 and 48 hours after surgery. Blood markers of cardiac injury: B-type natriuretic peptide and Troponin will be measured before surgery, immediately after surgery, 24 and 48 hours after surgery in order to establish changes in the markers between the mentioned pre and post-operative time points.
Measured: Pre and post operatively (immediately before and after surgery, 24 and 48 hours after surgery)
Secondary outcomes (3)
Protein and mRNA expression in the cardiac tissue related to the preconditioning process.
Cardiac tissue will be obtained only from patients who require tissue excision as part of the surgical procedure. Protein and mRNA expression will be assessed after extraction.
Measured: Expression assessed at the time of tissue extraction
End organ damage assessment by measurement of markers relevant to lung and kidney function and evaluate a possible benefit from preconditioning.
Blood markers (creatinin, cystatin C, Neutrophil gelatinase associated lipocalin,cGMP and Phosphodiesterase 5)will be measured before surgery, immediately after surgery, 24 and 48 hours after surgery in order to establish changes in the markers between the mentioned pre and post-operative time points.
Measured: Pre and post operatively (immediately before and after surgery, 24 and 48 hours after surgery)
Systemic immune response assessment by measurement of inflammatory mediators such as cytokines and nitric oxide metabolites.
Inflammatory blood markers (MDA, isoprostanes, NO metabolites, Cytokines, adhesion molecules, among others)will be measured before surgery, immediately after surgery, 24 and 48 hours after surgery in order to establish changes in the markers between the mentioned pre and post-operative time points
Measured: Pre and postoperatively (immediately before and after surgery, 24 and 48 hours after surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2012 (estimated)
- Study startJan 2013
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischaemic Reperfusion InjuryStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- NHS Greater Glasgow and Clyde
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maribel Verdesoto, University of Glasgow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01680601
- Sponsor's protocol ID
- GN12KH253
- Status last verified
- Apr 2015
- First submitted
- 29 Aug 2012
- Last updated
- 20 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Remote Ischaemic Preconditioning in Cardiac Dysfunction and End-organ Injury Following Cardiac Surgery With Cardiopulmonary Bypass in Children.
- ClinicalTrials.gov ID
- NCT01680601
- Acronym / sponsor ID
- GN12KH253
- Conditions
- Ischaemic Reperfusion Injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- NHS Greater Glasgow and ClydeUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 7 Sep 2012 (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.
Surgical correction of congenital heart defects in children requires the utilization of cardiopulmonary bypass, a technique that temporarily substitutes heart and lung functions during surgery. During this process the patient´s circulation is controlled by a bypass machine which provides several functions:
- Controls the patient's blood flow by pumping of blood in the patient's body.
- Controls the correct oxygen levels in the patient's blood.
- Regulates the temperature and fluid level of the blood. This process triggers negative responses in the heart and throughout the whole body, potentially resulting in injury to the heart and other organs such as brain, kidneys and lungs.
Remote ischaemic preconditioning (RIPC) describes a procedure that could potentially reduce the injury to heart muscle during cardiac surgery. The procedure consists of the inflation of a blood pressure cuff on the child's leg for three 5 minute cycles. This process acts by briefly reducing blood flow to the leg muscle, which will then activate the body´s own protective mechanisms and thereby reduce heart injury.
Several animal studies have been used to help the understanding of the mechanisms behind this process, and trials in human adults have showed optimistic results; however evidence regarding the paediatric population is limited and necessary since children present different basal profiles, risks and requirements.
The investigators propose a randomized clinical trial assessing the efficacy of RIPC to provide protection against injury to the heart and other organs in children going through cardiac surgery using CPB at the Royal Hospital for Sick Children. The research project will have a translational approach, integrating basic molecular mechanisms to clinical outcome. The investigators hope it will allow the understanding and utilisation of the patient´s own protective mechanisms, reducing CPB-related injury and ultimately improving patient outcome.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RIPC group | Experimental | Procedure: Remote ischaemic preconditioning (RIPC)Patients assigned to this arm will go through a remote ischaemic preconditioning (RIPC)protocol |
| Control | Placebo comparator | Procedure: PlaceboPatients assigned to this arm will not receive the intervention, however the protocol will be applied to a wooden block in order to maintain blinding to relatives and investigators. |
Who may qualify
- Ages
- 2 days to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children undergoing cardiac surgery for correction of congenital heart defects utilizing cardiopulmonary bypass and cold blood cardioplegia strategy of myocardial protection.
- Children whose parents understand the child's condition, the purpose of the study and are willing to participate.
Key exclusion criteria (6 listed)
- Children whose parents either are unwilling or do not have sufficient understanding of the study.
- Emergency operations, where there is insufficient time to establish the study protocol.
- Premature children presenting a corrected gestational age under 35 weeks.
- Presence of extracardiac abnormalities, apart from cases of Down and DiGeorge syndromes which will be included.
- Patients with known viral blood infections (e.g. HIV, Hepatitis B) or severe congenital infection.
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 |
|---|---|---|
| Remote ischaemic preconditioning (RIPC)RIPC will be performed by 3 cycles of 5 minute leg ischaemia induced by inflation of a blood pressure cuff to 40 mmHg above the patient's systolic pressure. This protocol will be performed at two phases: 24 hours before surgery and during anaesthesia immediately prior to surgery. | Procedure or surgery | RIPC group |
| Placebo | Procedure or surgery | Control |
Primary outcome
Measurement of the final cardiac injury after cardiopulmonary bypass assessed by markers of cardiac injury and echocardiography.
Time frame: Pre and post operatively (immediately before and after surgery, 24 and 48 hours after surgery)
Echocardiography assessment will take place before surgery, 24 and 48 hours after surgery. Blood markers of cardiac injury: B-type natriuretic peptide and Troponin will be measured before surgery, immediately after surgery, 24 and 48 hours after surgery in order to establish changes in the markers between the mentioned pre and post-operative time points.
3 secondary outcomes
Protein and mRNA expression in the cardiac tissue related to the preconditioning process.
Time frame: Expression assessed at the time of tissue extraction
End organ damage assessment by measurement of markers relevant to lung and kidney function and evaluate a possible benefit from preconditioning.
Time frame: Pre and post operatively (immediately before and after surgery, 24 and 48 hours after surgery)
Systemic immune response assessment by measurement of inflammatory mediators such as cytokines and nitric oxide metabolites.
Time frame: Pre and postoperatively (immediately before and after surgery, 24 and 48 hours after surgery)
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 20 Apr 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remote ischaemic preconditioning (RIPC) in people with Ischaemic Reperfusion Injury, run by NHS Greater Glasgow and Clyde at 1 site in United Kingdom.
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 2 inclusion and 6 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 20 Apr 2015. 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 Kingdom. 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?
Measurement of the final cardiac injury after cardiopulmonary bypass assessed by markers of cardiac injury and echocardiography. (time frame: Pre and post operatively (immediately before and after surgery, 24 and 48 hours after surgery)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Apr 2015.