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NCT01312623 Clinical Trial

Organ Protection by Remote Ischemic Preconditioning for Surgical Treatment of Pediatric Congenital Heart Disease

Cerebral Ischemia Clinical Trial

— RIPHeart  

Official title:
Organ Protection by Remote Ischemic Preconditioning for Surgical Treatment of Pediatric Congenital Heart Disease

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT01312623
Other study ID # Fudickar5
Secondary ID
Status Terminated
Phase N/A
First received March 8, 2011
Last updated October 31, 2016
Start date March 2010
Est. completion date May 2014

Study information
Verified date October 2016
Source University of Schleswig-Holstein
Contact n/a
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility
Status Terminated
Enrollment 31
Est. completion date May 2014
Est. primary completion date March 2014
Accepts healthy volunteers No
Gender Both
Age group N/A to 16 Years
Eligibility Inclusion Criteria:

- congenital heart surgery

Exclusion Criteria:

- hypoplastic left heart syndrome

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Other:
• Remote ischemic preconditioning
Remote ischemic preconditioning at the left leg.

Locations
Country Name City State
Germany University Hospital Schleswig-Holstein, Campus Kiel Kiel Schleswig-Holstein

Sponsors (1)
Lead Sponsor Collaborator
University of Schleswig-Holstein

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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. 48 hours No
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