Targeted tissue perfusion versus macrocirculation-guided standard care in patients with septic shock (TARTARE-2S): study protocol and statistical analysis plan for a randomized controlled trial

Table 2 The trial targets for the treatment arms. (Register hourly up to 24 h (every 2 h thereafter until study endpoint using tick boxes for targets)

I. Intervention group – targeted tissue perfusion (TTP) care:
Primary targets
Capillary refill time (CRT)/every hour	<3 s
Skin mottling [17]/every hour	Absent
Peripheral temperature/every hour	Warm
Urine output/every hour	≥0.5 mL/kg/h
Arterial lactate [7]/per 2 h	<2.0 mmol/L
Mean arterial pressure (MAP)	50–65 mmHg (minimum as a safety limit)
^aIf previous hypertension [7]	^a65–70 mmHg
^bIf oliguria <0.3 ml/kg [7]	^b2-h trial 75–80 mmHg,
	If diuresis improves, continue for 2 h and re-evaluate
Secondary target
Continuous SvO₂ [7], if available	>65 %^c
II. Control group – macrocirculatory targets-guided (MCG) standard care
Primary targets
Mean arterial pressure (MAP) [7]	65–75 mmHg
^aIf previous hypertension [7]	^a75–80 mmHg
^bIf oliguria <0.3 ml/kg	^b2-h trial 85–90 mmHg
	If diuresis better, continue for 2 h and re-evaluate
Central venous pressure (CVP) [7]	8–12 mmHg
	Adequate fluid therapy is indicated to restore clinical hypovolemia up to the recommended CVP level of 8–12 mmHg, if needed
Urine output [7]	≥0.5 mL/kg/h
Secondary target
Continuous SvO₂ [7], if available	>65 %^c

Dellinger et al. [7] according to the SSCG – Surviving Sepsis Campaign Guidelines: MAP, CVP, diuresis, SvO₂ – 1C, lactate – 2C (1 – a recommendation, 2 – a suggestion, C – low level of evidence)
^aHigher MAP targets may be required for septic shock patients with previous hypertension; ^band a test of providing higher MAP target for 2 h is recommended for those with oliguria
^bThe treating physicians should target to the lowest possible vasopressor use to maintain the highlighted lowest possible MAP level in each treatment arm; however, allowing individual higher MAP targets with specific reasons
^cMeasuring of ScVO₂ is not recommended [1, 4, 5]. If monitoring is clinically required, use of a pulmonary artery catheter (PAC) is recommended. Pulse continuous cardiac output (PICCO) may be used for thermodilution cardiac output measurements

ISSN: 1745-6215