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Remote Ischaemic Preconditioning in Children Undergoing Cardiac Surgery

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ClinicalTrials.gov Identifier: NCT01680601
Recruitment Status : Completed
First Posted : September 7, 2012
Last Update Posted : April 20, 2015
Sponsor:
Information provided by (Responsible Party):
Maribel Verdesoto, University of Glasgow

Tracking Information
First Submitted Date  ICMJE August 29, 2012
First Posted Date  ICMJE September 7, 2012
Last Update Posted Date April 20, 2015
Study Start Date  ICMJE January 2013
Actual Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 4, 2012)
Measurement of the final cardiac injury after cardiopulmonary bypass assessed by markers of cardiac injury and echocardiography. [ Time Frame: Pre and post operatively (immediately before and after surgery, 24 and 48 hours after surgery) ]
Echocardiography assessment will take place before surgery, 24 and 48 hours after surgery. Blood markers of cardiac injury: B-type natriuretic peptide and Troponin will be measured before surgery, immediately after surgery, 24 and 48 hours after surgery in order to establish changes in the markers between the mentioned pre and post-operative time points.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01680601 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 23, 2014)
  • Protein and mRNA expression in the cardiac tissue related to the preconditioning process. [ Time Frame: Expression assessed at the time of tissue extraction ]
    Cardiac tissue will be obtained only from patients who require tissue excision as part of the surgical procedure. Protein and mRNA expression will be assessed after extraction.
  • End organ damage assessment by measurement of markers relevant to lung and kidney function and evaluate a possible benefit from preconditioning. [ Time Frame: Pre and post operatively (immediately before and after surgery, 24 and 48 hours after surgery) ]
    Blood markers (creatinin, cystatin C, Neutrophil gelatinase associated lipocalin,cGMP and Phosphodiesterase 5)will be measured before surgery, immediately after surgery, 24 and 48 hours after surgery in order to establish changes in the markers between the mentioned pre and post-operative time points.
  • Systemic immune response assessment by measurement of inflammatory mediators such as cytokines and nitric oxide metabolites. [ Time Frame: Pre and postoperatively (immediately before and after surgery, 24 and 48 hours after surgery) ]
    Inflammatory blood markers (MDA, isoprostanes, NO metabolites, Cytokines, adhesion molecules, among others)will be measured before surgery, immediately after surgery, 24 and 48 hours after surgery in order to establish changes in the markers between the mentioned pre and post-operative time points
Original Secondary Outcome Measures  ICMJE
 (submitted: September 4, 2012)
  • Protein and mRNA expression in the cardiac tissue related to the preconditioning process. [ Time Frame: Expression assessed at the time of tissue extraction ]
    Cardiac tissue will be obtained only from patients who require tissue excision as part of the surgical procedure. Protein and mRNA expression will be assessed after extraction.
  • End organ damage assessment by measurement of markers relevant to lung and kidney function and evaluate a possible benefit from preconditioning. [ Time Frame: Pre and post operatively (immediately before and after surgery, 24 and 48 hours after surgery) ]
    Blood markers (creatinin, cystatin C, Neutrophil gelatinase associated lipocalin,cGMP and Phosphodiesterase 5)will be measured before surgery, immediately after surgery, 24 and 48 hours after surgery in order to establish changes in the markers between the mentioned pre and post-operative time points.
  • Systemic immune response assessment by measurement of inflammatory mediators such as cytokines and nitric oxide metabolites. [ Time Frame: Pre and postoperatively (immediately before and after surgery, 24 and 48 hours after surgery) ]
    Inflammatory blood markers (MDA, isoprostanes, NO metabolites, Cytokines, addhession molecules, among others)will be measured before surgery, immediately after surgery, 24 and 48 hours after surgery in order to establish changes in the markers between the mentioned pre and post-operative time points
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Remote Ischaemic Preconditioning in Children Undergoing Cardiac Surgery
Official Title  ICMJE Effect of Remote Ischaemic Preconditioning in Cardiac Dysfunction and End-organ Injury Following Cardiac Surgery With Cardiopulmonary Bypass in Children.
Brief Summary

Surgical correction of congenital heart defects in children requires the utilization of cardiopulmonary bypass, a technique that temporarily substitutes heart and lung functions during surgery. During this process the patient´s circulation is controlled by a bypass machine which provides several functions:

  1. Controls the patient's blood flow by pumping of blood in the patient's body.
  2. Controls the correct oxygen levels in the patient's blood.
  3. Regulates the temperature and fluid level of the blood. This process triggers negative responses in the heart and throughout the whole body, potentially resulting in injury to the heart and other organs such as brain, kidneys and lungs.

Remote ischaemic preconditioning (RIPC) describes a procedure that could potentially reduce the injury to heart muscle during cardiac surgery. The procedure consists of the inflation of a blood pressure cuff on the child's leg for three 5 minute cycles. This process acts by briefly reducing blood flow to the leg muscle, which will then activate the body´s own protective mechanisms and thereby reduce heart injury.

Several animal studies have been used to help the understanding of the mechanisms behind this process, and trials in human adults have showed optimistic results; however evidence regarding the paediatric population is limited and necessary since children present different basal profiles, risks and requirements.

The investigators propose a randomized clinical trial assessing the efficacy of RIPC to provide protection against injury to the heart and other organs in children going through cardiac surgery using CPB at the Royal Hospital for Sick Children. The research project will have a translational approach, integrating basic molecular mechanisms to clinical outcome. The investigators hope it will allow the understanding and utilisation of the patient´s own protective mechanisms, reducing CPB-related injury and ultimately improving patient outcome.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Ischaemic Reperfusion Injury
Intervention  ICMJE
  • Procedure: Remote ischaemic preconditioning (RIPC)
    RIPC will be performed by 3 cycles of 5 minute leg ischaemia induced by inflation of a blood pressure cuff to 40 mmHg above the patient's systolic pressure. This protocol will be performed at two phases: 24 hours before surgery and during anaesthesia immediately prior to surgery.
  • Procedure: Placebo
Study Arms  ICMJE
  • Experimental: RIPC group
    Patients assigned to this arm will go through a remote ischaemic preconditioning (RIPC)protocol
    Intervention: Procedure: Remote ischaemic preconditioning (RIPC)
  • Placebo Comparator: Control
    Patients assigned to this arm will not receive the intervention, however the protocol will be applied to a wooden block in order to maintain blinding to relatives and investigators.
    Intervention: Procedure: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 17, 2015)
51
Original Estimated Enrollment  ICMJE
 (submitted: September 4, 2012)
80
Actual Study Completion Date  ICMJE March 2015
Actual Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Children undergoing cardiac surgery for correction of congenital heart defects utilizing cardiopulmonary bypass and cold blood cardioplegia strategy of myocardial protection.
  • Children whose parents understand the child's condition, the purpose of the study and are willing to participate.

Exclusion Criteria:

  • Children whose parents either are unwilling or do not have sufficient understanding of the study.
  • Emergency operations, where there is insufficient time to establish the study protocol.
  • Premature children presenting a corrected gestational age under 35 weeks.
  • Presence of extracardiac abnormalities, apart from cases of Down and DiGeorge syndromes which will be included.
  • Patients with known viral blood infections (e.g. HIV, Hepatitis B) or severe congenital infection.
  • Patients with severe preoperative brain injury.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 16 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01680601
Other Study ID Numbers  ICMJE GN12KH253
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Maribel Verdesoto, University of Glasgow
Study Sponsor  ICMJE NHS Greater Glasgow and Clyde
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account NHS Greater Glasgow and Clyde
Verification Date April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP