Table 3 Randomization, treatment, and evolution of DSS: comparison between HSL and RL
Patients included | 50 | ||
|---|---|---|---|
Randomization | HSL | RL | P* |
Patients randomized | 25 | 25 | |
Patients withdrawn | 1 | 3 | 0.60 |
Patients studied | 24 | 22 | |
Per protocol analysis (n = 46) | |||
Initial shock treatment (number of patients) | |||
One bolus/two boluses | 18/6 | 17/5 | >0.99 |
HES infusions | 4 | 1 | 0.30 |
Number of recurrent shocks within the first 12 hours (number of patients) | |||
Yes/No | 7/17 | 2/20 | 0.14 |
HES infusions | 1 | 0 | 0.48 |
Total HES infusions (24 hours) | 10 | 1 | 0.005 |
Concomitant therapies | |||
Blood products | |||
Thrombocytes | 1 | 4 | 0.18 |
Cryoprecipitate | 0 | 2 | 0.22 |
Fresh frozen plasma | 1 | 3 | 0.34 |
Antibiotics | 7 | 4 | 0.60 |
Furosemide | 3 | 3 | >0.99 |
Catecholamines | 1 | 1 | >0.99 |
Antipyretic | 6 | 1 | 0.13 |
Total colloid (HES + plasma) (24 hours) | 11 | 4 | 0.06 |
Intent-to-treat analysis (n = 50) | |||
Outcome | |||
Recovery | 22 | 20 | 0.70 |
Forced discharge | 2 | 2 | >0.99 |
Death | 1 | 3 | 0.60 |
Adverse events/complications | |||
DIC | 3 | 5 | 0.70 |
Encephalopathy | 4 | 3 | >0.99 |
Respiratory distress syndrome | 1 | 0 | >0.99 |
Acute liver failure | 0 | 2 | 0.47 |