Helen Betts – Lead Research Nurse. PICS-SG Cambridge 2005.

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Presentation transcript:

Helen Betts – Lead Research Nurse

PICS-SG Cambridge 2005

The CHIP Trial –Developed jointly by PICS-SG clinicians and LSHTM Clinical Trials Centre –Funded by DoH HTA July 2006

The CHIP Trial A randomised, controlled trial comparing ‘Tight Glycaemic Control’ with conventional (‘permissive’) glycaemic control in critically ill and post-surgical children in Paediatric Intensive Care

DMC DoH HTA CICUPICUCICU PICU Children and Parents RBH LSHTM Organisation

CHiP STUDY SITES Leeds Manchester Liverpool Cambridge London (St Mary’s, GOSH, RBH) Southampton Bristol Birmingham Sheffield

Trial Administration ‘Run in’ period for each centre ‘Sign off’ by Trial Management Group Performance of research sites will be monitored –(recruitment rate; data quality etc.)

Recruitment Aiming to recruit 1500 children over 2 years from ~ 12 PICU / CICU’s Funding for 11 x 0.5 wte Research Nurses Role of RN’s –Ensure recruitment –‘Teach’ TGC protocol to clinical team –Ensure trial documentation complete

Lead Nurse Role Linchpin Translate theory from protocol making it user friendly and safe Overseeing training needs and providing tools for safe recruitment Work closely with each study site providing support throughout the life of the study

Tight page 1

Other support…

website:

24 hour CHiP telephone support Tel :

Study Sites and Research Teams Royal Brompton Hospital: CI / PI - Duncan Macrae (Sponsor Site) Lead Nurse - Helen Betts Carolyn Webster St Mary’s Hospital, London: PI - David Inwald TBA Emma Waite Great Ormond Street Hospital: PI - Mark Peters (PICU) PI - Mike Broadhead (CICU) TBA London MCRN: Louise Spencer Lorraine Hodgson

Study Sites and Research Teams Birmingham Children’s Hospital: PI - Kevin Morris Simon Laker MCRN: Pauline Darbyshire Lisa Hydes Manchester Children’s Hospital: PI - Peter-Marc Fortune Chloe Rishton MCRN: Mark Sidaway Sheffield Children’s Hospital: PI - Anton Mayer TBA MCRN: Penny Scardifield Sam Jones

Study Sites and Research Teams Liverpool Alder Hey Children’s Hospital: PI - Paul Baines Katie Blackie MCRN: Helen Hill Southampton: PI - John Pappachan Helen Cracknell Lucy Grace Lorna St John Leeds: PI - Mark Darwski TBA

Study Sites and Research Teams Cambridge:PI - Robert Tasker Deborah White Bristol Children’s Hospital: PI - Margrid Schindler TBA Caroline Haines MCRN: Natalie Fineman

Progress to date…. 9 sites with Ethical approval 3 with R & D approval RN recruited in 4 sites

Help….. Obtain R&D and LREC approval at remaining sites Recruit a Research nurse for remaining sites Involve the whole PICU team

The biggest PICU study ever to be performed in the UK and an amazing opportunity to work in collaboration with so many centres of excellence No evidence of the effect of TGC in children CHiP will provide an evidence basis for future management of critically ill children

CHiP Needs

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