| Study period | |||||||
---|---|---|---|---|---|---|---|---|
 | Enrollment | Allocation | Post-allocation | Close-out | ||||
Time point | Day -1 | 0 | Day 1 | Day 2 | Day 3 | Day 4 | Day 5 | Day 30 |
Enrollment | ||||||||
Eligibility screen | × |  |  |  |  |  |  |  |
Deferred or informed consent | × |  |  |  |  |  |  |  |
Allocation |  | × |  |  |  |  |  |  |
Interventions | ||||||||
Treatment arm |  |  | ×/× | ×/× | ×/× |  |  |  |
Control arm |  |  | ×/× | ×/× | ×/× |  |  |  |
Assessments | ||||||||
Baseline variables | ||||||||
Demographics | × |  |  |  |  |  |  |  |
Past medical history | × |  |  |  |  |  |  |  |
Type of diagnosis on admission | × |  |  |  |  |  |  |  |
APACHE-2 score at randomization | × |  |  |  |  |  |  |  |
SOFA score at randomization | × |  |  |  |  |  |  |  |
Diagnosis of ARDS at randomization | × |  |  |  |  |  |  |  |
Time since hemodynamic stability | × |  |  |  |  |  |  |  |
Length of ICU stay at randomization | × |  |  |  |  |  |  |  |
Laboratory results | Â | Â | Â | Â | Â | Â | Â | Â |
Renal function tests |  |  | × | × | × | × | × |  |
Serum chemistry |  |  | × | × | × | × | × |  |
Serum albumin levels |  |  | × | × | × | × | × |  |
Serum total protein levels |  |  | × |  | × |  | × |  |
Colloid osmotic pressure |  |  | × |  | × |  | × |  |
Blood gas analysis |  |  | × | × | × | × | × |  |
Troponin I levels |  |  | × | × | × | × | × |  |
Serum lactate levels |  |  | × | × | × | × | × |  |
Complete blood count |  |  | × | × | × | × | × |  |
Physiologic data | Â | Â | Â | Â | Â | Â | Â | Â |
Vital signs |  |  | × | × | × | × | × |  |
Glasgow Coma Scale rating |  |  | × | × | × | × | × |  |
Weight |  |  | × | × | × | × | × |  |
Ventilator data |  |  | × | × | × | × | × |  |
Fluid intake and output |  |  | × | × | × | × | × |  |
Diuretic doses and timing |  |  | × | × | × | × | × |  |
Clinical outcomes | ||||||||
Study treatment held? |  |  | × | × | × | × | × |  |
Need for dialysis? |  |  | × | × | × | × | × | × |
Hypotension requiring fluids |  |  | × | × | × | × | × |  |
Hypotension requiring vasopressors |  |  | × | × | × | × | × |  |
Suspected infection? |  |  | × | × | × | × | × |  |
Intubation status |  |  | × | × | × | × | × | × |
Date of transfer from ICU |  |  | × | × | × | × | × | × |
Date of death |  |  | × | × | × | × | × | × |