Assessment of hemodynamic efficacy and safety of 6% hydroxyethylstarch 130/0.4 vs. 0.9% NaCl fluid replacement in patients with severe sepsis: The CRYSTMAS study

Table 1 Exclusion criteria.

Related to pre-existing renal impairment
- Known serum creatinine >3.39 mg/dl^a
- 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 shock^b
- 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.

ISSN: 1364-8535