critical care studies summaries

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Protocol v1.0 23/10/2023
Rotherham Principal Investigator: Dr Susie Robinson


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research topic:

Treatment for new onset AF

trial groups:

Intervention: Amiodarone for treatment of NOAF
Control: Beta-blockade for treatment of NOAF

inclusion criteria:

• Patient in as adult ICU (age >16 years)
• Onset of NOAF during the acute illness (A&E, deterioration on ward, after surgery) having previously been in sinus rhythm and not known to previously had AF
• A minimum duration of AF of at least 30 minutes
• Usual electrolyte management with potassium and magnesium according to site practice
• A clinical indication to treat NOAF as determined by the attending clinician

exclusion criteria:

• Any know previous documented history of AF, whether permanent, persistent or paroxysmal
• Receipt of amiodarone or a beta-blocker in the previous 24 hours
• Current concomitant medication that are contraindicated with the intervention/comparator medication
• Serum Potassium of <4mmol/L
• Serum Magnesium of <1.0 mmol/L
• Patients having undergone cardiac surgery during the current hospital admission, defined as any surgery including stent procedures such as percutaneous coronary interventions or other angioplasty procedures done on the heart muscle, valves or thoracic arteries including the thoracic part of the aorta
• Thyrotoxicosis
• Withdrawal of life support therapy within 24 hours
• Other thoracic surgery that ingresses the thorax
• Any other known contraindication or known sensitivity to beta-blockers or amiodarone
• Known pregnancy or patients currently know to be breast feeding

randomisation:

ABBRUPT randomisation can be done on redcap database with your own login once training is completed.
Link: https://bctu-redcap.bham.ac.uk/redcap_v14.3.14/index.php?pid=502

what to document:

This patient has been entered into a research trial:
Trial name: ABBRUPT
Local study ref. no: 23-11-06
Principal Investigator: Dr Susie Robinson
[Patient Name] met all inclusion and no exclusion for the ABBRUPT trial at [Date/Time]. Eligibility confirmed with Dr [XXX]. Randomisation performed by online website by [Staff Name].
[copy and paste the randomisation : date/time/trial ID number/randomisation allocation]
Select as appropriate:
Amiodarone for treatment of NOAF
OR
Beta-blockade for treatment of NOAF
 
For full protocol details of trial can be found in research office DLE91 PGME Corridor or contact 6060.
Any questions please contact Cheryl Graham, Clinical Research Nurse, 6060.