Heart IschemiaRIPHeartNCT01312623
Organ Protection by Remote Ischemic Preconditioning for Surgical Treatment of Pediatric Congenital Heart Disease
A study testing Remote ischemic preconditioning in people with Heart Ischemia and Cerebral Ischemia, run by University Hospital Schleswig-Holstein at 1 site in Germany.
Trial summary
Cardiac surgery is associated with risk of perioperative inflammation and ischemia leading to cerebral and myocardial morbidity and mortality. Ischemic preconditioning by repetitive ischemic episodes at an organ can reduce damage resulting from consecutive prolonged ischemia in that organ. Read more about this study
- Who is it for?
- Ages Up to 16 years
- Conditions the study is for
- Heart Ischemia, Cerebral Ischemia
- What is being tested?
- Remote ischemic preconditioning
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2010to May 2014
- 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 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- congenital heart surgery
Who cannot join
- hypoplastic left heart syndrome
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Hospital Schleswig-Holstein, Campus Kiel
Kiel, Schleswig-Holstein, 24105
About this study
Cardiac surgery is associated with risk of perioperative inflammation and ischemia leading to cerebral and myocardial morbidity and mortality. Ischemic preconditioning by repetitive ischemic episodes at an organ can reduce damage resulting from consecutive prolonged ischemia in that organ. Remote ischemic preconditioning is defined as ischemic preconditioning by repetitive ischemic episodes of an organ remote from the organ to be protected, e.g. ischemic episodes of a limb can reduce ischemic damage of the heart. Animal studies as well as human studies have shown that ischemic preconditioning can protect the heart from intraoperative ischemia. Remote preconditioning by repetitive limb ischemia has been applied in humans in some studies.12-14 However, the published data is not yet sufficient to support evidence based recommendations for clinical practice. In particular, available data regarding the influence of remote preconditioning on inflammatory and ischemic damage of brain and heart in children following surgery of congenital heart disease are limited. Hence, this prospective, controlled and randomized study was designed to perform remote ischemic preconditioning in children after induction of anesthesia for pediatric heart surgery and to investigate the effect on postoperative organ function in comparison to a control group.
Read the detailed description
Arterial blood flow to the right leg of the patients is interrupted by inflating a cuff around the thigh up to a pressure of 15 mmHg above the systolic blood pressure for five minutes. Thereafter the pressure is released for another five minutes and the procedure is repeated fourfold. Cerebral and myocardial damage are examined by postoperative laboratory exams in comparison to preoperative baseline values. In addition to this, systemic immune response, renal function, duration of intensive care and time to discharge from hospital are compared between groups. Mechanisms of remote preconditioning are investigated by analyzing gene expression in human heart tissue obtained during surgery and in leukocytes.
The investigation is not associated with any known risks for the children.
- Conditions
- Heart Ischemia, Cerebral Ischemia
- Being tested
- Remote ischemic preconditioning
- Medical subject headings
- Brain Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote ischemic preconditioningOther
Remote ischemic preconditioning at the left leg.
| Study group | Role | What they receive |
|---|---|---|
| Remote ischemic preconditioning | Experimental | Remote ischemic preconditioning at the left leg. Receives: Other: Remote ischemic preconditioning |
| Control | No intervention | No ischemic preconditioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum troponin T
Serum troponin T is measured 8, 16 and 24 hours after end of surgery. Values of serum troponin T are compared between remote ischemic preconditioning group and control group.
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2011 (estimated)
- Study startMar 2010
- Primary completionMar 2014
- Study completionMay 2014
Why it stopped: Terminated, because it is not possible to recruit enough participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart IschemiaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Schleswig-Holstein
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Axel Fudickar, University Hospital Schleswig-Holstein
- Investigators
- Axel Fudickar, Dr., Principal investigator, University Hospital Schleswig-Holstein
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01312623
- Sponsor's protocol ID
- Fudickar5
- Acronym
- RIPHeart
- Status last verified
- Oct 2016
- First submitted
- 8 Mar 2011
- Last updated
- 1 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Organ Protection by Remote Ischemic Preconditioning for Surgical Treatment of Pediatric Congenital Heart Disease
- ClinicalTrials.gov ID
- NCT01312623
- Acronym / sponsor ID
- RIPHeart / Fudickar5
- Conditions
- Heart Ischemia, Cerebral Ischemia
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated, because it is not possible to recruit enough participants
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University Hospital Schleswig-HolsteinUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Mar 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 10 Mar 2011 (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.
Cardiac surgery is associated with risk of perioperative inflammation and ischemia leading to cerebral and myocardial morbidity and mortality. Ischemic preconditioning by repetitive ischemic episodes at an organ can reduce damage resulting from consecutive prolonged ischemia in that organ. Remote ischemic preconditioning is defined as ischemic preconditioning by repetitive ischemic episodes of an organ remote from the organ to be protected, e.g. ischemic episodes of a limb can reduce ischemic damage of the heart. Animal studies as well as human studies have shown that ischemic preconditioning can protect the heart from intraoperative ischemia. Remote preconditioning by repetitive limb ischemia has been applied in humans in some studies.12-14 However, the published data is not yet sufficient to support evidence based recommendations for clinical practice. In particular, available data regarding the influence of remote preconditioning on inflammatory and ischemic damage of brain and heart in children following surgery of congenital heart disease are limited. Hence, this prospective, controlled and randomized study was designed to perform remote ischemic preconditioning in children after induction of anesthesia for pediatric heart surgery and to investigate the effect on postoperative organ function in comparison to a control group.
Detailed description
Arterial blood flow to the right leg of the patients is interrupted by inflating a cuff around the thigh up to a pressure of 15 mmHg above the systolic blood pressure for five minutes. Thereafter the pressure is released for another five minutes and the procedure is repeated fourfold. Cerebral and myocardial damage are examined by postoperative laboratory exams in comparison to preoperative baseline values. In addition to this, systemic immune response, renal function, duration of intensive care and time to discharge from hospital are compared between groups. Mechanisms of remote preconditioning are investigated by analyzing gene expression in human heart tissue obtained during surgery and in leukocytes.
The investigation is not associated with any known risks for the children.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Remote ischemic preconditioning | Experimental | Other: Remote ischemic preconditioningRemote ischemic preconditioning at the left leg. |
| Control | No intervention | –No ischemic preconditioning |
Who may qualify
- Ages
- Up to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- congenital heart surgery
Key exclusion criteria (1 listed)
- hypoplastic left heart syndrome
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 ischemic preconditioningRemote ischemic preconditioning at the left leg. | Other | Remote ischemic preconditioning |
Primary outcome
serum troponin T
Time frame: 48 hours
Serum troponin T is measured 8, 16 and 24 hours after end of surgery. Values of serum troponin T are compared between remote ischemic preconditioning group and control group.
Results and safety
The study was stopped early (reason given: Terminated, because it is not possible to recruit enough participants). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2016.
- Individual participant dataSharing planned: No
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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.
Axel Fudickar, Dr. principal investigator
University Hospital Schleswig-Holstein
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 ischemic preconditioning in people with Heart Ischemia and Cerebral Ischemia, run by University Hospital Schleswig-Holstein at 1 site in Germany.
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: stopped early, as of the sponsor's last update on 1 Nov 2016. 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 Germany. 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. 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 was stopped early (reason given: Terminated, because it is not possible to recruit enough participants). Results are not available in the source record.
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?
serum troponin T (time frame: 48 hours). 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 1 Nov 2016.