NCT02358382

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.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

November 26, 2014

Completed
3 months until next milestone

First Posted

Study publicly available on registry

February 9, 2015

Completed
1.1 years until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
Last Updated

August 23, 2016

Status Verified

August 1, 2016

Enrollment Period

1.3 years

First QC Date

November 26, 2014

Last Update Submit

August 22, 2016

Conditions

Heart Defects, Congenital

Outcome Measures

Primary Outcomes (1)

  • MAPCA Flow

    To determine the optimal conditions for treating cyanotic patients with MAPCAs on CPB

    During surgery

Secondary Outcomes (1)

  • 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

Study Arms (2)

Alpha Stat

NO INTERVENTION

Standard CPB blood gas management conditions

pH Stat

EXPERIMENTAL

pH stat blood gas management conditions.

Drug: pH Stat

Interventions

pH StatDRUG

pH stat blood gas management - increased carbon dioxide content of administered gas mixture.

pH Stat

Eligibility Criteria

Age1 Day - 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Great Ormond Street Hospital

London, WC1N 3JH, United Kingdom

RECRUITING

Related Publications (7)

  • 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.

    PMID: 19808629BACKGROUND

  • 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.

    PMID: 19817735BACKGROUND

  • 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.

    PMID: 7426156BACKGROUND

  • 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.

    PMID: 4067114BACKGROUND

  • 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.

    PMID: 3996062BACKGROUND

  • 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.

    PMID: 14752407BACKGROUND

  • 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.

    PMID: 5914855BACKGROUND

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Richard W Issitt

    Great Ormond Street Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Richard W Issitt

CONTACT

0044 (0) 278138287richard.issitt@gosh.nhs.uk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 26, 2014

First Posted

February 9, 2015

Study Start

March 1, 2016

Primary Completion

July 1, 2017

Last Updated

August 23, 2016

Record last verified: 2016-08

Locations

GB(1)