Organ Protection by Remote Ischemic Preconditioning for Surgical Treatment of Pediatric Congenital Heart Disease (RIPHeart)
Primary Purpose
Heart Ischemia, Cerebral Ischemia
Status
Terminated
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Remote ischemic preconditioning
Sponsored by
About this trial
This is an interventional treatment trial for Heart Ischemia
Eligibility Criteria
Inclusion Criteria:
- congenital heart surgery
Exclusion Criteria:
- hypoplastic left heart syndrome
Sites / Locations
- University Hospital Schleswig-Holstein, Campus Kiel
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Remote ischemic preconditioning
Control
Arm Description
Remote ischemic preconditioning at the left leg.
No ischemic preconditioning
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01312623
First Posted
March 8, 2011
Last Updated
October 31, 2016
Sponsor
University Hospital Schleswig-Holstein
1. Study Identification
Unique Protocol Identification Number
NCT01312623
Brief Title
Organ Protection by Remote Ischemic Preconditioning for Surgical Treatment of Pediatric Congenital Heart Disease
Acronym
RIPHeart
Official Title
Organ Protection by Remote Ischemic Preconditioning for Surgical Treatment of Pediatric Congenital Heart Disease
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Terminated
Why Stopped
Terminated, because it is not possible to recruit enough participants
Study Start Date
March 2010 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
May 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital Schleswig-Holstein
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Ischemia, Cerebral Ischemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Remote ischemic preconditioning
Arm Type
Experimental
Arm Description
Remote ischemic preconditioning at the left leg.
Arm Title
Control
Arm Type
No Intervention
Arm Description
No ischemic preconditioning
Intervention Type
Other
Intervention Name(s)
Remote ischemic preconditioning
Intervention Description
Remote ischemic preconditioning at the left leg.
Primary Outcome Measure Information:
Title
serum troponin T
Description
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.
Time Frame
48 hours
10. Eligibility
Sex
All
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
congenital heart surgery
Exclusion Criteria:
hypoplastic left heart syndrome
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Axel Fudickar, Dr.
Organizational Affiliation
University Hospital Schleswig-Holstein, Campus Kiel
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Schleswig-Holstein, Campus Kiel
City
Kiel
State/Province
Schleswig-Holstein
ZIP/Postal Code
24105
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Organ Protection by Remote Ischemic Preconditioning for Surgical Treatment of Pediatric Congenital Heart Disease
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