| |
Study period
|
|---|
| |
Enrolment
|
Allocation
|
Post-allocation
|
Close-out
|
|---|
| |
Entrya
|
0
|
Day 1–3
|
Day 4
|
Day 5–8
|
Day 10
|
Discharge*
|
Day 30*
|
|---|
|
Time point
|
|
Eligibility screen
|
+
| | | | | | | |
|
Informed consent
|
+
| | | | | | | |
|
Allocation
| |
+
| | | | | | |
|
Interventions
|
|
SVPE
| | |
+
|
+
|
+
| | | |
|
Non-SVPE
| | |
+
|
+
|
+
| | | |
|
Assessments
|
|
SVPE procedureb
| | |
+
|
+
|
+
| | | |
|
Hemodynamicc
|
+
|
+
|
+
|
+
|
+
|
+
|
+
| |
|
Biochemistryd
|
+
|
±‡
|
±‡
|
+
|
±‡
|
+
| | |
|
Infection screeninge
|
+
|
±‡
|
±‡
|
+
|
±‡
|
+
| |
+
|
|
Neurologicalf
|
+
|
+
| |
+
| |
+
|
+
|
+
|
- *For patients treated with SVPE. ‡ Assessed as per indication
-
aWithin 14 days of onset of muscle weakness
-
bNumber and duration of each SVPE session and volume of the plasma removed and the replacement fluid infused
-
cBlood pressure, heart rate, body temperature, and pulse oximetry
-
dHemoglobin (g/L), coagulation profile, serum level of calcium, magnesium, albumin, renal, and liver function test
-
eComplete blood count, erythrocyte sedimentation rate (ESR), C-reactive protein, and microbiological investigations to assess CLABSI, CAUTI, and VAP
-
fGBS disability score and MRC sum score
