Brain Vascular Reactivity to Hypothermic Circulatory Arrest With Antegrade Cerebral Perfusion During Aortic Arch Surgery

NCT03047876 | Unknown DMC

• 1 other identifier: 220447
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Many neonates and infants who undergo complex cardiac surgery are affected by neurological developmental delays. Whilst catastrophic events are immediately identifiable from clinical examination or by macro changes on MRI or CT scans, smaller changes are often not immediately visible or detected. This is an observational pilot study examining brain vascular reaction to hypothermic circulatory arrest with antegrade cerebral perfusion and neuro-protection techniques during aortic arch surgery in neonates and infants. A combination of duplex ultrasound and transcranial doppler will be used to record in-depth information on the cerebrovascular changes that occur during the entire length of the surgical procedure and during the early postoperative period. The proposed techniques and equipment are non-invasive and are in use clinically to evaluate brain perfusion in a similar age group. During aortic arch surgery, the patient's body and brain temperature is reduced to values between 18 and 24 degrees centigrade in order to decrease metabolic demand that provides a form of metabolic protection. However, there is no consensus within the clinical community regarding the optimal temperature at which to perform surgery. Moreover, in order to improve cerebral perfusion, the brain is perfused via the right internal carotid artery with cold blood. At Alder Hey Children Hospital, this surgery is undertaken by the three surgeons but, due to clinical preference, differs in relation to the temperature at which surgery is undertaken. This provides the opportunity to observe the impact of different temperatures on cerebral vascular reactivity in neonates and young infants The arguments for future comparisons and a larger randomised study will be made based on the information gained from this observational study.

Conditions

Cardiac; Aortic Arch Surgery; Brain Vascular; Neonates; Infants

Keywords

cardiac; aortic arch surgery; Brain vascular reactivity; neonates; infants

Outcome Measures

Primary Outcomes (1)

• Feasibility Data

  Quantify the impact of surgical and post-operative clinical intervention of aortic arch surgery on cerebral perfusion

  1 year

Study Arms (1)

All neonates and infants undergoing aortic arch surgery

Children, from neonatal age to late infancy, undergoing aortic arch surgery (n=20) will have cerebral perfusion measurements during surgery, including during the cooling and rewarming phase, whilst on cardiopulmonary bypass and during the recovery period in the intensive care unit

Procedure: aortic arch surgery

Interventions

aortic arch surgery PROCEDURE

Children, from neonatal age to late infancy, undergoing aortic arch surgery (n=20) will have cerebral perfusion measurements during surgery, including during the cooling and rewarming phase, whilst on cardiopulmonary bypass and during the recovery period in the intensive care unit

All neonates and infants undergoing aortic arch surgery

Eligibility Criteria

• Age: 1 Day - 1 Year
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children, from neonatal age to late infancy, undergoing aortic arch surgery (n=25) will have cerebral perfusion measurements during surgery, including during the cooling and rewarming phase, whilst on cardiopulmonary bypass and during the recovery period in the intensive care unit

You may qualify if:

• All neonates and infants undergoing aortic arch surgery

You may not qualify if:

• Procedures undertaken as an emergency
• Parents/guardians who do not wish for their child to participate
• Parents/ guardians who are unable to provide written consent

Sponsors & Collaborators

• Alder Hey Children's NHS Foundation Trust: lead

Study Sites (1)

Alder Hey Children's Hospital

Liverpool, Merseyside, L12 2AP, United Kingdom

Location

Related Publications (5)

• Gaynor JW, Stopp C, Wypij D, Andropoulos DB, Atallah J, Atz AM, Beca J, Donofrio MT, Duncan K, Ghanayem NS, Goldberg CS, Hovels-Gurich H, Ichida F, Jacobs JP, Justo R, Latal B, Li JS, Mahle WT, McQuillen PS, Menon SC, Pemberton VL, Pike NA, Pizarro C, Shekerdemian LS, Synnes A, Williams I, Bellinger DC, Newburger JW; International Cardiac Collaborative on Neurodevelopment (ICCON) Investigators. Neurodevelopmental outcomes after cardiac surgery in infancy. Pediatrics. 2015 May;135(5):816-25. doi: 10.1542/peds.2014-3825.

  PMID: 25917996 BACKGROUND

• McCrindle BW, Tchervenkov CI, Konstantinov IE, Williams WG, Neirotti RA, Jacobs ML, Blackstone EH; Congenital Heart Surgeons Society. Risk factors associated with mortality and interventions in 472 neonates with interrupted aortic arch: a Congenital Heart Surgeons Society study. J Thorac Cardiovasc Surg. 2005 Feb;129(2):343-50. doi: 10.1016/j.jtcvs.2004.10.004.

  PMID: 15678045 BACKGROUND

• Wypij D, Newburger JW, Rappaport LA, duPlessis AJ, Jonas RA, Wernovsky G, Lin M, Bellinger DC. The effect of duration of deep hypothermic circulatory arrest in infant heart surgery on late neurodevelopment: the Boston Circulatory Arrest Trial. J Thorac Cardiovasc Surg. 2003 Nov;126(5):1397-403. doi: 10.1016/s0022-5223(03)00940-1.

  PMID: 14666011 BACKGROUND

• Andropoulos DB, Stayer SA, McKenzie ED, Fraser CD Jr. Regional low-flow perfusion provides comparable blood flow and oxygenation to both cerebral hemispheres during neonatal aortic arch reconstruction. J Thorac Cardiovasc Surg. 2003 Dec;126(6):1712-7. doi: 10.1016/s0022-5223(03)01027-4.

  PMID: 14688677 BACKGROUND

• Ruffer A, Tischer P, Munch F, Purbojo A, Toka O, Rascher W, Cesnjevar RA, Jungert J. Comparable Cerebral Blood Flow in Both Hemispheres During Regional Cerebral Perfusion in Infant Aortic Arch Surgery. Ann Thorac Surg. 2017 Jan;103(1):178-185. doi: 10.1016/j.athoracsur.2016.05.088. Epub 2016 Aug 23.

  PMID: 27526653 BACKGROUND

Central Study Contacts

Attilio Lotto

CONTACT

0151 228 4811; attilio.lotto@alderhey.nhs.uk

Helen Jones

CONTACT

0151 228 4811; helen.jones@alderhey.nhs.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2017
• First Posted: February 9, 2017
• Study Start: March 1, 2020
• Primary Completion: March 19, 2021
• Study Completion: March 19, 2021
• Last Updated: May 9, 2019

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)