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

This study has been terminated.
(The study was terminated, because it was not possible to recruit enough participants to complete the study until the primary completion date.)
Sponsor:
Information provided by (Responsible Party):
Axel Fudickar, University of Schleswig-Holstein
ClinicalTrials.gov Identifier:
NCT01312623
First received: March 8, 2011
Last updated: May 21, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention
Heart Ischemia
Cerebral Ischemia
Other: Remote ischemic preconditioning

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Organ Protection by Remote Ischemic Preconditioning for Surgical Treatment of Pediatric Congenital Heart Disease

Resource links provided by NLM:


Further study details as provided by University of Schleswig-Holstein:

Primary Outcome Measures:
  • serum troponin T [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
    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.


Enrollment: 31
Study Start Date: March 2010
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Remote ischemic preconditioning
Remote ischemic preconditioning at the left leg.
Other: Remote ischemic preconditioning
Remote ischemic preconditioning at the left leg.

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.

  Eligibility

Ages Eligible for Study:   up to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • congenital heart surgery

Exclusion Criteria:

  • hypoplastic left heart syndrome
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01312623

Locations
Germany
University Hospital Schleswig-Holstein, Campus Kiel
Kiel, Schleswig-Holstein, Germany, 24105
Sponsors and Collaborators
University of Schleswig-Holstein
Investigators
Principal Investigator: Axel Fudickar, Dr. University Hospital Schleswig-Holstein, Campus Kiel
  More Information

No publications provided

Responsible Party: Axel Fudickar, Dr. med., University of Schleswig-Holstein
ClinicalTrials.gov Identifier: NCT01312623     History of Changes
Other Study ID Numbers: Fudickar5
Study First Received: March 8, 2011
Last Updated: May 21, 2014
Health Authority: Germany: Ethics Commission

Additional relevant MeSH terms:
Cerebral Infarction
Brain Ischemia
Heart Diseases
Ischemia
Heart Defects, Congenital
Brain Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Stroke
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Cardiovascular Abnormalities
Congenital Abnormalities

ClinicalTrials.gov processed this record on August 21, 2014