SHAMROC: Restrictive Versus Liberal Fluids In Sepsis Follow-Up
Key Takeaways
- No differences were observed between restrictive and liberal fluid strategies across the patient-centered domains assessed at 6 months, and 12-month outcomes were also similar.
- Follow-up assessments covered cognition, executive function, disability, mobility, and health-related quality of life after randomization.
- Pre-specified 50% trimmed-mean analyses addressed informative censoring from death, and SHAMROC included 898 participants from CLOVERS, with loss to follow-up reducing the 6-month analytic sample.
SHAMROC was an open-label randomized controlled trial follow-up within CLOVERS in patients with sepsis-induced hypotension. Of 1563 CLOVERS participants, 898, or 57%, were included in SHAMROC. A total of 196 participants were lost to follow-up, leaving 702 analyzed at 6 months, including 431 survivors and 271 non-survivors. Baseline characteristics were similar between groups, providing a consistent starting point for the outcome comparisons.
At 6 months, no group differences were observed in cognitive function, executive function, disability status, mobility, or health-related quality of life. The corresponding instruments were Montreal Cognitive Assessment-Blind Score, Hayling Sentence Completion Test, Activity of Daily Living Score, PROMIS Mobility Score, and EQ-5D-5L. Trimmed mean differences were 0.11 for MoCA-Blind, 95% CI -1.44 to 1.70, and 0.38 for Hayling, 95% CI -0.97 to 1.76. Differences were 0.03 for Activity of Daily Living, 95% CI -0.84 to 0.90, 0.72 for PROMIS Mobility, 95% CI -2.20 to 3.64, and -0.01 for EQ-5D-5L, 95% CI -0.07 to 0.06.
Pre-specified analyses used 50% trimmed means to prevent informative censoring of deceased patients. Outcomes also did not differ at 12 months.