NCT01680601

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. 1.Controls the patient's blood flow by pumping of blood in the patient's body.
  2. 2.Controls the correct oxygen levels in the patient's blood.
  3. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 29, 2012

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 7, 2012

Completed
4 months until next milestone

Study Start

First participant enrolled

January 1, 2013

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

April 20, 2015

Status Verified

April 1, 2015

Enrollment Period

2.2 years

First QC Date

August 29, 2012

Last Update Submit

April 17, 2015

Conditions

Ischaemic Reperfusion Injury

Outcome Measures

Primary Outcomes (1)

  • Measurement of the final cardiac injury after cardiopulmonary bypass assessed by markers of cardiac injury and echocardiography.

    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.

    Pre and post operatively (immediately before and after surgery, 24 and 48 hours after surgery)

Secondary Outcomes (3)

  • Protein and mRNA expression in the cardiac tissue related to the preconditioning process.

    Expression assessed at the time of tissue extraction

  • End organ damage assessment by measurement of markers relevant to lung and kidney function and evaluate a possible benefit from preconditioning.

    Pre and post operatively (immediately before and after surgery, 24 and 48 hours after surgery)

  • Systemic immune response assessment by measurement of inflammatory mediators such as cytokines and nitric oxide metabolites.

    Pre and postoperatively (immediately before and after surgery, 24 and 48 hours after surgery)

Study Arms (2)

RIPC group

EXPERIMENTAL

Patients assigned to this arm will go through a remote ischaemic preconditioning (RIPC)protocol

Procedure: Remote ischaemic preconditioning (RIPC)

Control

PLACEBO COMPARATOR

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.

Procedure: Placebo

Interventions

Remote ischaemic preconditioning (RIPC)PROCEDURE

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.

RIPC group
PlaceboPROCEDURE
Control

Eligibility Criteria

Age2 Days - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Hospital for Sick Children - Yorkhill

Glasgow, G3 8SJ, United Kingdom

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD student

Study Record Dates

First Submitted

August 29, 2012

First Posted

September 7, 2012

Study Start

January 1, 2013

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

April 20, 2015

Record last verified: 2015-04

Locations

GB(1)