- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02358382
The Management of Systemic-Pulmonary Collateral Blood Flow in Cyanotic Children During Cardiopulmonary Bypass - Pilot Study
August 22, 2016 updated by: Great Ormond Street Hospital for Children NHS Foundation Trust
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.
Study Overview
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 Type
Interventional
Enrollment (Anticipated)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Richard W Issitt
- Phone Number: 0044 (0) 278138287
- Email: richard.issitt@gosh.nhs.uk
Study Locations
-
-
-
London, United Kingdom, WC1N 3JH
- Recruiting
- Great Ormond Street Hospital
-
Contact:
- Ricahrd Issitt
- Phone Number: 02078138287
- Email: richard.issitt@gosh.nhs.uk
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 day to 5 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Alpha Stat
Standard CPB blood gas management conditions
|
|
Experimental: pH Stat
pH stat blood gas management conditions.
|
pH stat blood gas management - increased carbon dioxide content of administered gas mixture.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
MAPCA Flow
Time Frame: During surgery
|
To determine the optimal conditions for treating cyanotic patients with MAPCAs on CPB
|
During surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
Time Frame: 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
|
3 days Post Surgical Period
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Richard W Issitt, Great Ormond Street Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2016
Primary Completion (Anticipated)
July 1, 2017
Study Registration Dates
First Submitted
November 26, 2014
First Submitted That Met QC Criteria
February 6, 2015
First Posted (Estimate)
February 9, 2015
Study Record Updates
Last Update Posted (Estimate)
August 23, 2016
Last Update Submitted That Met QC Criteria
August 22, 2016
Last Verified
August 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 13CC21
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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