EvaLuation of early CRRT and beta-blocker InTervention in patients with ECMO (ELITE) trial: study protocol for a 2 × 2 partial factorial randomized controlled trial

Table 1 Study period

	CRRT screening	CRRT randomization	Beta-blocker screening	Beta-blocker randomization	Days post-randomization
	CRRT screening	CRRT randomization	Beta-blocker screening	Beta-blocker randomization	Day 3	Day 7	Day 30	Day 365
Window for time for evaluation							± 5 days	± 35 days
Visit number		1		1	2	3	4	5
Informed consent		×		×
Demographic data	×		×
Physical measures	×	×	×	×
Medical history		×		×
Concomitant medications	×	×	×	×	×	×	×	×
Physical examinations^a		×		×
Vital signs^b		×		×	×	×
Complete blood count^c		×		×	×	×
Arterial blood gas^d		×		×	×	×
Biochemistry items^e	×		×		×	×
Coagulation indexes^f		×		×	×	×
UCG^g		×		×	×	×
Intake and output volume in 24 h					×
Medication, type, and dose^h		×		×	×	×	×	×
Mechanical ventilation and mode		×		×	×	×	×
Left ventricular unloading method					×	×	×
RRT	×				×	×	×	×
APACHE II score		×		×
SOFA score		×		×
EQ-5D score								×
SAEs					×	×	×:	×

^aPhysical examinations: height (cm) and weight (kg)
^bVital signs: blood pressure (mmHg), pulse (beats/min), heart rate (beats/min), temperature (°C), and respiratory (/min)
^cComplete blood count: white blood cell count (10³/mm³), hemoglobin (g/dL), and platelet count (10⁹/L)
^dArterial blood gas: PH, PaO₂ (mmHg), PaCO₂ (mmHg), K⁺ (mmol/L), Na⁺ (mmol/L), hematocrit (%), and lactic acid (mmol/L)
^eBiochemistry items: creatine (μmol/L) and total bilirubin (μmol/L)
^fCoagulation indexes: PT (s) and APTT (s)
^gUCG: left ventricular ejection fraction (%), left ventricular end-diastolic diameter (cm), moderate and above pulmonary hypertension, and moderate and above tricuspid regurgitation
^hMedication: dopamine, dobutamine, epinephrine, norepinephrine, vasopressin, pituitrin, milrinone, and beta blockers

ISSN: 1745-6215