№ files_lp_3_process_7_032567
Multi-centre clinical trial protocol and governance summary outlining design, eligibility criteria, interventions, regulatory requirements, and data protection provisions for a UK randomised controlled study of treatments for new onset atrial fibrillation in intensive care units.
Acronym: ABBRUPT
Organ / Institution: University of Birmingham
Unit: Birmingham Clinical Trials Unit (BCTU)
Trial Office: ABBRUPT Trial Office
Country: United Kingdom
Regulatory Framework: UK Data Protection Regulations
Policy Framework: UK Policy Framework for Health and Social Care Research
Trial Design: Pragmatic open-label interventional multi-centre two-arm randomised controlled trial with internal pilot and economic evaluation
Objectives: To compare clinical and cost effectiveness of beta blockers versus amiodarone for new onset atrial fibrillation in intensive care and to conduct cost-effectiveness and cost-utility analyses at 90-day follow-up
Target Population: Patients aged 16 years and over in intensive care units with new onset atrial fibrillation
Sample Size: 2560 patients
Setting: At least 60 intensive care units across the UK
Interventions: Amiodarone versus beta blockers (including bisoprolol, metoprolol, esmolol, propranolol, atenolol, labetalol, carvedilol, landiolol)
Primary Outcome: 90-day mortality
Secondary Outcomes: Clinical and economic outcomes including ICU and hospital measures
Eligibility Criteria: Defined inclusion and exclusion criteria for patients with new onset atrial fibrillation in ICU
Data Management: Contact details retained indefinitely on a BCTU database and subject to written request under UK Data Protection Regulations
Oversight Requirements: Approval required from relevant Trust or Health Board Management prior to patient consent
Consent Requirements: Written informed consent and participant information sheet on Trust/Health Board headed paper
Local Governance: Compliance with Good Clinical Practice and UK Policy Framework for Health and Social Care Research
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