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

NCT01312623 | Terminated

• 1 other identifier: Fudickar5
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Ischemia; Cerebral Ischemia

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Remote ischemic preconditioning

EXPERIMENTAL

Remote ischemic preconditioning at the left leg.

Other: Remote ischemic preconditioning

Control

NO INTERVENTION

No ischemic preconditioning

Interventions

Remote ischemic preconditioning OTHER

Remote ischemic preconditioning at the left leg.

Remote ischemic preconditioning

Eligibility Criteria

• Age: Up to 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• congenital heart surgery

You may not qualify if:

• hypoplastic left heart syndrome

Sponsors & Collaborators

• University Hospital Schleswig-Holstein: lead

Study Sites (1)

University Hospital Schleswig-Holstein, Campus Kiel

Kiel, Schleswig-Holstein, 24105, Germany

Location

MeSH Terms

Conditions

Brain Ischemia

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Axel Fudickar, Dr.

  University Hospital Schleswig-Holstein

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. med.

Study Record Dates

• First Submitted: March 8, 2011
• First Posted: March 10, 2011
• Study Start: March 1, 2010
• Primary Completion: March 1, 2014
• Study Completion: May 1, 2014
• Last Updated: November 1, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)