Table 2

OVATION-65 trial timeline

	Study period
	Days	Days											Months
	Enrolment/Allocation	Post-allocation											Months
Time points	1	2	3	4	5–6	7	8–9	10	11–13	14	15–27	28	6 months
Enrolment
Eligibility screen	x
Informed consent	x
Allocation	x
Intervention
Permissive hypotension (MAP 60–65 mm Hg) versus usual care*
Assessments
Baseline variables
Diagnosis of admission	x
Severity of illness (APACHE II score)	x
Pre-existing comorbidities (Clinical Frailty Score)	x
Outcomes
hsTnT†	x		x			x
Biomarkers of organ injury‡	x		x			x
Global tissue dysoxia (lactate)	x		x			x
Organ function including renal function (SOFA score)	x	x	x	x		x		x		x		x
Resource utilisation§
Mortality at 90 days and 6 months													x
Cognitive impairment (TICS) at 6 months													x
Stroke
Clinically detected supraventricular arrhythmia
Limb or intestinal ischaemia
Stage 3 acute kidney injury¶
Other variables
Protocol adherence**
Co-interventions††

*MAP target while receiving vasopressor therapy up to day 28, or discontinuation for >24 hours.
†hsTnT at day 3 is the primary outcome and at day 7 is a secondary outcome.
‡NT-proBNP, GFAP, MBP, NSE, ALT, FABP, CK.
§Duration of mechanical ventilation, renal replacement therapy, vasopressor therapy, ICU and hospital stay.
¶As defined by KDIGO criteria.
**See text for definition.
††See text for definition.
ALT, alanine aminotransferase; APACHE II, Acute Physiology and Chronic Health Evaluation II; CK, creatine kinase; FABP, intestinal-type fatty acid binding protein; GFAP, glial fibrillar acidic protein; hsTnT, high-sensitivity cardiac troponin T; KDIGO, Kidney Disease Improving Global Outcomes; MAP, mean arterial pressure; MBP, myelin basic protein; NSE, neuron-specific enolase; NT-proBNP, N-terminal pro-B-type natriuretic peptide; OVATION-65, Optimal VAsopressor TitraTION in patients 65 years and older; SOFA, Sequential Organ Failure Assessment; TICS, Telephone Interview for Cognitive Status.