Participant timeline
Item | Screening/baseline | Final visit | |
V 1 | V 2 | V 3 | |
Date | Day 0 | Days 190 | Day 180 |
Clinical evaluation | X | ||
Informed consent | X | X* | |
Randomisation | X | ||
Medical history | X | ||
Demography | X | ||
Physical examination | X | X | |
Vital signs† | X | X | |
Routine laboratory testing‡ | X | X | |
Experimental treatment | x | x | |
Endpoints evaluation§ | x | X | |
AE recording | X¶ |
*Informed consent: consent from the patient can be obtained at enrolment but might be confirmed (after or emergency enrolment if the patient cannot consent because of sedation) later during the ICU course and up to the ICU discharge day.
†Vital signs include temperature, heart rate and arterial blood pressure.
‡Routine laboratory testing (blood): haemoglobin, haematocrit, RCC, WCC, PC; INR, PTT, electrolytes, creatinine, ALT, AST, AP, LDH, CRP, arterial blood gases, lactate, albumin.
§Status (alive vs dead) will be collected daily from enrolment to day 90 (main outcome) and at day 180. SOFA score will be collected at enrolment at day 1, day 2 and day 7; electrolytes and fluid balance will be collected at enrolment, day 1, day 2. Electrolytes AEs and nosocomial infections will be collected during the ICU stay with a censored date at day 28. Organ support and ICU and Hospital length of stay will be collected during the ICU stay with a censored date at day 90. Quality of Llife (EQ5D) and autonomy score (Functional Independence Measure score) will be collected at Dday 90 and Dday 180 solely at the Montpellier - Nimes site.
¶Until day 28.
**
AE, adverse event; ALT, Alanine transaminase; AP, Alkaline Phosphatase; AST, Aspartate transaminase; CRP, C reactive protein; EQ5D, European Quality of Life Five Dimension; ICU, intensive care unit; INR, International Normalised Ratio; LDH, Lactate Deshydrogenase; PC, Platelets Count; PTT, Partial thromboplastin time; RCC, red cell count; SOFA, Sequential Organ Failure Assessment; WCC, white cell count.