1. There was no significant difference in mortality among septic shock patients in the intensive care unit (ICU) between standard and restricted intravenous (IV) fluid treatment.

2. There were no significant differences in the incidence of serious adverse events between standard and restricted intravenous fluid treatment.

Evidence Rating Level: 1 (Excellent)

Study Rundown: Early and aggressive fluid resuscitation is known to improve survival in patients with septic shock. Yet, excessive fluid administration following initial resuscitation could lead to edema and organ damage. Currently, there are no guidelines for using restrictive or standard IV fluid strategies in patients with septic shock after initial resuscitation due to a paucity of data on their comparative outcomes. The present randomized trial evaluated adult patient mortality and adverse events of restriction and standard IV fluid strategies for septic shock patients in the ICU. Patients were followed for 90 days after starting treatment. There were no significant differences in mortality at 90 days between standard and restricted strategies. The incidence of serious adverse events was also not significantly different between groups. However, patient recruitment was limited to study sites in European countries, which can reduce generalizability to other populations. Violations in IV fluid protocol (21.5% and 13% in restrictive- and standard-fluid groups respectively) could also affect patient and study outcomes.

Click to read the study in NEJM

In-Depth [randomized controlled trial]: In the present study, ICU patients over the age of 18 with septic shock onset within 12 hours of screening (n=1,554) were randomly assigned to receive the standard or restrictive IV fluid therapy in a 1:1 ratio. For the restrictive-fluid group, IV fluid could only be given to correct severe hypoperfusion, replace documented fluid loss such as gastrointestinal or drain losses, maintain a daily fluid intake of one liter, or for patients with contraindication for oral fluid intake. Patients were followed for 90 days after enrolling in the study. Patients remained in the ICU for a median of 5 days (interquartile ranges, 3 to 9 days for restrictive-fluid patients and 3 to 10 days for standard-fluid patients). The restrictive- and standard-fluid groups received a median of 1798mL and 3811mL of IV fluids, respectively. There was no significant difference in mortality between the restrictive- (42.3%) and standard-fluid (42.1%) groups. Similarly, no differences between the two groups were found in survival durations without life support or after hospital discharge. There was also no significant difference in the incidence of serious adverse events in the restrictive- (29.4%) and standard-fluid (30.8%) groups. Severe adverse events included cerebral, cardiac, intestinal, or limb ischemic events. In summary, the results from this study may support new guidelines for fluid management for ICU patients with septic shock.

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