Table 4.

Schedule for enrollment, interventions, and assessments

	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
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
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			×	×	×	×	×	×

APACHE-2, Acute Physiology and Chronic Health Evaluation-2; ARDS, acute respiratory distress syndrome; ICU, intensive care unit; SOFA, Sepsis-related Organ Failure Assessment.