Hope-icu trial
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Hope-ICU Trial(HalOPeridol: Effectiveness trial) A randomised, double-blind, placebo-controlled trial to compare the early administration of intravenous haloperidol versus placebo in the prevention and treatment of delirium in critically ill ventilated patients
EudraCT Number: 2009-017842-30 REC Number: 10/H0505/65 ISRCTN 83567338 Funding Body: National Institute for Health Research Version Number: 8Version Date 8th April 2012 Stage: FinalProtocol Substantial Amendments: Amendment No Date of Amendment Date of approval
Contact Names and NumbersRole Name, address, telephone Lead sponsor: West Hertfordshire Hospitals NHS Trust Vicarage Road Watford WD18 0HB
Tel: 01442 213141 Ext: 2473 Email: Fiona.smith@whht.nhs.uk Chief Investigator: Valerie Page, Consultant Critical Care Department of Anaesthesia Watford General Hospital Vicarage Road Watford WD18 0HB
Tel: 01923 217604 Email: Valerie.page@whht.nhs.uk Trial Co-ordinator: Ms Xiao Bei Zhao Department of Anaesthesia Watford General Hospital Vicarage Road Watford WD18 0HB
Tel: 01923 217604 Email: ZhaoBei.Xaio@whht.nhs.uk Trial Statistician: Dr Simon Gates Warwick Clinical Trials Unit University of Warwick Tel:02476 575850 Email: s.gates@warwick.ac.uk
University of Leeds Leeds Institute of Health Sciences Leeds
Tel: 0113 343 6989 Fax: 0113 246 0899 Email: D.Meads@leeds.ac.uk
Trial Steering CommitteeDr Neil Soni (Chair)Chelsea and Westminster HospitalDr Danny McAuleyRoyal Victoria Hospital, BelfastDr Valerie Page, Chief InvestigatorWest Hertfordshire Hospitals NHS TrustDr Gavin PerkinsBirmingham Heartlands HospitalDr Tom StambachWest Hertfordshire Hospitals NHS TrustMs Fiona SmithWest Hertfordshire Hospitals NHS TrustDr Simon Gates Warwick Clinical Trials Unit Professor Wes Ely Vanderbilt Medical Center Nashville
Dr James PickettResearch Grants OfficerAlzheimer’s SocietyData Monitoring and Ethics Committee Dr Martin Kuper (Chair)Consultant Intensive CareWhittington Hospital NHS TrustDr Mike GrocottConsultant Intensive Care Southampton Hospitals NHS Trust Dr Yogi Amin Consultant Neuroanaesthetist, University College Hospital London Dr David Wellsted Senior Lecturer University of Hertfordshire
Table of ContentsTitle Page Contact Names and Details Table of Contents List of abbreviations
2.1 Terminology 2.2 Pathophysiology 2.3 Outcomes 2.4 Rationale for using haloperidol 2.4.1 Delirium treatment 2.4.2 Lack of evidence 2.4.3 Potential benefits in ICU patients 2.4.4 Delirium prevention 2.4.5 The intervention is simple and cheap 2.4.6 Acceptable tolerability and side effects 2.4.7 Dosing regimen 2.4.8 Need for a trial 2.5 Rationale for plasma -amyloid levels 2.6 Good Clinical Practice 2.7 CONSORT Guidelines 3. Trial Design 3.1 Trial Summary 3.2 Flow Diagram 3.3 Trial Objectives 3.4 Trial Outcome 3.4.1 Primary Outcome 3.4.2 Secondary Outcomes 3.4.3 Definition primary outcome 3.4.4 Rationale 3.4.5 Definition of delirium and coma 3.4.6 Safety 3.5 Eligibility criteria 3.5.1 Inclusion Criteria 3.5.2 Exclusion Criteria 3.6 Screening of Patients not suitable for Trial 3.7 Consent 3.7.1 Patient Consent 3.7.2 Personal Legal Representative Consent 3.7.3 Professional Legal Representative Consent 3.7.4 Retrospective Patient Information 3.7.5 Withdrawal of Consent 3.8 Randomisation 3.9 Trial Procedures 3.9.1 Test treatment 3.9.2 Control (placebo) Treatment 3.9.3 Treatment Preparation and Supply 3.9.4 Treatment Administration 3.9.5 Treatment Reduction 3.9.6 Treatment termination criteria 3.9.7 Treatment compliance 3.9.8 Drug Accountability 3.9.10 Blood Sampling Mechanisms 3.10 Clinical Management of Patients in the Trial 3.10.1 Rescue protocol for delirium 3.10.2.Sedation Management 3.10.3 Extrapyramidal Symptoms 3.10.4 Prolonged QTc 3.10.5 Blinding and procedures for unblinding 3.11 Post treatment follow-up 3.12 Pharmacovigilance 3.12.1 Definition of Adverse Events 3.12.2 Assessment of causality 3.12.3 Adverse Event reporting period 3.12.4 Adverse Event reporting requirements 3.12.5 Adverse Event reporting 3.12.6 Serious Adverse Event reporting 3.13 End of Trial
4.1 Training Issues 4.2 Data Collection and Management 4.3.Follow-up at 6 months 4.4 Data Storage 4.5 Archiving 5. Data Analysis 5.1 Sample Size Calculation 5.3 Economic Evaluation 6. Trial Organisation 6.1 Sponsor 6.2 Trial Steering Committee (TSC) 6.3 Data Monitoring and Ethics Committee (DMEC) 6.3.1 Safety 6.4 Administration 6.5 Indemnity 6.6 Monitoring and Safety Procedures 6.7 Safety and well being of study subjects 7. Ethics and Regulatory Approval 8. Protocol Amendments 9. Publication 10. References |