Table 1 |
|
Exclusion criteria. |
|
Related to pre-existing renal impairment |
|
|
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- Known serum creatinine >3.39 mg/dla |
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- Anuria lasting more than 8 hours despite fluid resuscitation |
|
- Requirement for renal support (either continuous or discontinuous techniques, including intermittent hemodialysis, hemofiltration, and hemodiafiltration) |
|
|
|
Related to the potential effect on the primary endpoint |
|
|
|
- Volume expansion with >3 L of fluid (crystalloid and/or colloid) since diagnosis of severe sepsis or refractory septic shockb |
|
- Patients receiving norepinephrine or epinephrine at a dose >0.5 μg/kg/min or dopamine at a dose >15 μg/kg/min at the time of screening |
|
|
|
aIf a creatinine value >3.39 mg/dl became available only after beginning treatment with the study drug, treatment could be continued if the risk/benefit ratio for the individual patient was regarded as positive by the investigator. bPatients treated with low dose vasopressors were not excluded provided they were responsive to fluid resuscitation as demonstrated by an individual fluid challenge. |
|
Guidet et al. Critical Care 2012 16:R94 doi:10.1186/cc11358 |
