Closed Or Open after Source Control Laparotomy for Severe Complicated Intra-Abdominal Sepsis (the COOL trial): study protocol for a randomized controlled trial

Table 2 Overview of study outcomes

	Indicator	Timeline
Primary outcome	Mortality	90 days
Secondary outcomes
Logistical	Days free of ICU	30 days
	Days free of ventilation	30 days
	Days free of RRT^a	30 days
	Days free of hospital	30 days
Physiological	APACHE II^b scores	Up to 30 days^c
	SOFA^d scores	Up to 30 days^c
	Pa0₂/Fi0₂^e ratios	Up to 30 days^c
	ARDS^f scores	Up to 30 days^c
Safety	Enterocutaneous fistula	30 days
	ACS^g and/or severe IAH^h	30 days
	Intra-abdominal abscess	30 days
Biological	Il-6	Up to 30 daysⁱ
	IL-10	Up to 30 daysⁱ
	Procalcitonin	Up to 30 daysⁱ
	Activated protein C	Up to 30 daysⁱ
	High mobility group box protein 1	Up to 30 daysⁱ
	Mitochondrial DNA	Up to 30 daysⁱ
	C3a and C5a	Up to 30 daysⁱ
Microbiological	Intra-abdominal	Up to 30 days^j
Microbiological	Microbiological cultures
Mass cytometry	Intra-peritoneal inflammatory cells	Up to 30 days^k
Economic	Micro-costed resource consumption	1 year
Quality of life	Euroqol EQ-5D-5L	90 days and 1 year
Quality of life	SF-36	90 days and 1 year

ISSN: 1749-7922