The Management of Systemic-Pulmonary Collateral Blood Flow in Cyanotic Children During Cardiopulmonary Bypass - Pilot Study

Not Applicable

• Conditions: Heart Defects, Congenital
• Interventions: Drug: pH Stat

• Registration Number: NCT02358382
• Lead Sponsor: Great Ormond Street Hospital for Children NHS Foundation Trust

Brief Summary

The purpose of the study is to determine whether it is possible to manage the flow of blood through blood vessels using varying levels of carbon dioxide during cardiac surgery, and what effect this has on how well the major organs of the body work.

Detailed Description

A great number of studies have shown that MAPCAs are a real issue for these patients, who require far higher blood flows than previously suggested. However, the optimal method of CPB is still unknown. Recent research by Sakamoto et al., showed that a raised carbon dioxide (pCO2) increased brain blood flow in cyanotic patients, suggesting a noticeable decrease in aorto-pulmonary blood shunting. However, the mechanism of this action is not understood and it is unclear if this observation is an associated or causative one. Whilst the vasoconstrictive (narrowing of vessels) effect of hypoxia has been well documented, with and without high carbon dioxide, there are no reports indicating that pCO2 alone increases the narrowing of blood vessels in the lung. We hypothesize that a rise in pCO2 could cause a shift in blood flow from pulmonary to systemic circulation, either through direct constricting action on MAPCA vessels, or through a vasoconstriction of blood vessels in the lung. Furthermore, we predict the phenomenon could potentially be used to optimize the method of treatment, ensuring that vital organs receive the correct amount of blood flow during the surgical correction of these rare congenital heart diseases.

Study Timeline

• Study First Submitted: 2014-11-26
• Study First Submitted QC: 2015-02-06
• Study First Posted: 2015-02-09
• Study Start: 2016-03
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-22
• Last Update Posted: 2016-08-23
• Primary Completion: 2017-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Patients whose parents/guardians are willing and able to provide written informed consent for participation in the study
• Patients undergoing elective TCPC surgery
• MRI proven presence of MAPCA vessels
• Patients between 1 day and 5 years of age

Exclusion Criteria

• Emergency surgery
• Documented history of cognitive impairment (may have an effect on biochemical markers of cerebral injury)
• Documented history of major organ dysfunction

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
pH Stat	pH Stat	pH stat blood gas management conditions.

Primary Outcome Measures

Name	Time	Method
MAPCA Flow	During surgery	To determine the optimal conditions for treating cyanotic patients with MAPCAs on CPB

Secondary Outcome Measures

Name	Time	Method
Maximum levels of Biochemical markers of Cerebral and Tissue Injury, as measure by Neurone-Specific Enolase, Creatine Kinase, Gamma Glutamyl Transferase, Lactate Dehydrogenase and Near Infrared Spectroscopy	3 days Post Surgical Period	To determine if increased pCO2 levels results in altered organ and tissue perfusion as measure by Neurone-Specific Enolase, Creatine Kinase, Gamma Glutamyl Transferase, Lactate Dehydrogenase and Near Infrared Spectroscopy

Trial Locations

Locations (1)

Great Ormond Street Hospital; 🇬🇧 London, United Kingdom