The Management of Systemic-Pulmonary Collateral Blood Flow in Cyanotic Children During Cardiopulmonary Bypass - Pilot Study
Primary Purpose
Heart Defects, Congenital
Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
pH Stat
Sponsored by
About this trial
This is an interventional treatment trial for Heart Defects, Congenital
Eligibility Criteria
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
Sites / Locations
- Great Ormond Street HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Alpha Stat
pH Stat
Arm Description
Standard CPB blood gas management conditions
pH stat blood gas management conditions.
Outcomes
Primary Outcome Measures
MAPCA Flow
To determine the optimal conditions for treating cyanotic patients with MAPCAs on CPB
Secondary Outcome Measures
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
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
Full Information
NCT ID
NCT02358382
First Posted
November 26, 2014
Last Updated
August 22, 2016
Sponsor
Great Ormond Street Hospital for Children NHS Foundation Trust
1. Study Identification
Unique Protocol Identification Number
NCT02358382
Brief Title
The Management of Systemic-Pulmonary Collateral Blood Flow in Cyanotic Children During Cardiopulmonary Bypass - Pilot Study
Official Title
The Management of Systemic-Pulmonary Collateral Blood Flow in Cyanotic Children During Cardiopulmonary Bypass - Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Unknown status
Study Start Date
March 2016 (undefined)
Primary Completion Date
July 2017 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Great Ormond Street Hospital for Children NHS Foundation Trust
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Defects, Congenital
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Alpha Stat
Arm Type
No Intervention
Arm Description
Standard CPB blood gas management conditions
Arm Title
pH Stat
Arm Type
Experimental
Arm Description
pH stat blood gas management conditions.
Intervention Type
Drug
Intervention Name(s)
pH Stat
Intervention Description
pH stat blood gas management - increased carbon dioxide content of administered gas mixture.
Primary Outcome Measure Information:
Title
MAPCA Flow
Description
To determine the optimal conditions for treating cyanotic patients with MAPCAs on CPB
Time Frame
During surgery
Secondary Outcome Measure Information:
Title
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
Description
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
Time Frame
3 days Post Surgical Period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Richard W Issitt
Phone
0044 (0) 278138287
Email
richard.issitt@gosh.nhs.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard W Issitt
Organizational Affiliation
Great Ormond Street Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Great Ormond Street Hospital
City
London
ZIP/Postal Code
WC1N 3JH
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ricahrd Issitt
Phone
02078138287
Email
richard.issitt@gosh.nhs.uk
12. IPD Sharing Statement
Citations:
PubMed Identifier
19808629
Citation
Whitehead KK, Gillespie MJ, Harris MA, Fogel MA, Rome JJ. Noninvasive quantification of systemic-to-pulmonary collateral flow: a major source of inefficiency in patients with superior cavopulmonary connections. Circ Cardiovasc Imaging. 2009 Sep;2(5):405-11. doi: 10.1161/CIRCIMAGING.108.832113. Epub 2009 Jul 8. Erratum In: Circ Cardiovasc Imaging. 2010 Jan;3(1):e1.
Results Reference
background
PubMed Identifier
19817735
Citation
Fujii Y, Kotani Y, Kawabata T, Ugaki S, Sakurai S, Ebishima H, Itoh H, Nakakura M, Arai S, Kasahara S, Sano S, Iwasaki T, Toda Y. The benefits of high-flow management in children with pulmonary atresia. Artif Organs. 2009 Nov;33(11):888-95. doi: 10.1111/j.1525-1594.2009.00895.x. Epub 2009 Oct 10.
Results Reference
background
PubMed Identifier
7426156
Citation
Haworth SG, Macartney FJ. Growth and development of pulmonary circulation in pulmonary atresia with ventricular septal defect and major aortopulmonary collateral arteries. Br Heart J. 1980 Jul;44(1):14-24. doi: 10.1136/hrt.44.1.14. No abstract available.
Results Reference
background
PubMed Identifier
4067114
Citation
Liao PK, Edwards WD, Julsrud PR, Puga FJ, Danielson GK, Feldt RH. Pulmonary blood supply in patients with pulmonary atresia and ventricular septal defect. J Am Coll Cardiol. 1985 Dec;6(6):1343-50. doi: 10.1016/s0735-1097(85)80223-0.
Results Reference
background
PubMed Identifier
3996062
Citation
Baile EM, Ling H, Heyworth JR, Hogg JC, Pare PD. Bronchopulmonary anastomotic and noncoronary collateral blood flow in humans during cardiopulmonary bypass. Chest. 1985 Jun;87(6):749-54. doi: 10.1378/chest.87.6.749.
Results Reference
background
PubMed Identifier
14752407
Citation
Sakamoto T, Kurosawa H, Shin'oka T, Aoki M, Isomatsu Y. The influence of pH strategy on cerebral and collateral circulation during hypothermic cardiopulmonary bypass in cyanotic patients with heart disease: results of a randomized trial and real-time monitoring. J Thorac Cardiovasc Surg. 2004 Jan;127(1):12-9. doi: 10.1016/j.jtcvs.2003.08.033.
Results Reference
background
PubMed Identifier
5914855
Citation
Kato M, Staub NC. Response of small pulmonary arteries to unilobar hypoxia and hypercapnia. Circ Res. 1966 Aug;19(2):426-40. doi: 10.1161/01.res.19.2.426. No abstract available.
Results Reference
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The Management of Systemic-Pulmonary Collateral Blood Flow in Cyanotic Children During Cardiopulmonary Bypass - Pilot Study
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