American journal of respiratory and critical care medicine · 2026
Effects of an early restrictive versus liberal fluid strategy on long-term patient-centered outcomes in sepsis-induced hypotension: an open-label, randomized controlled trial.
СтатьяРандомизированное исследованиеПоддержка NIH: внешняя программаПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Jorda Anselm, Gelbenegger Georg, Shapiro Nathan I, Douglas Ivor S, Whitman Casey, Chen Zhe, Hippensteel Joseph A, Kamphuis Lee A, Flick Robert J, Harhay Michael O, Caldwell Ellen, Zeitlinger Markus, Jilma Bernd, Iwashyna Theodore J, Hough Catherine L, Auriemma Catherine L
Аннотация
RATIONALE: The impact of fluid resuscitation strategies on patient-centered outcomes of sepsis survivors is unknown.
OBJECTIVES: To assess the effect of an early restrictive or liberal fluid resuscitation strategy on long-term functional outcomes in patients with sepsis-induced hypotension.
METHODS: SHAMROC (Sepsis-induced Hypotension: Assessing effect of Method of Resuscitation On Patient-centered Outcomes) prospectively assessed the impact of random assignment to a restrictive or liberal fluid resuscitation strategy for sepsis-induced hypotension outcomes at 6 and 12 months after randomization in the NIH NHLBI PETAL Network's CLOVERS trial (NCT03434028). The pre-specified analyses used trimmed means at 50% to prevent informative censoring of deceased patients.
MEASUREMENTS AND MAIN RESULTS: Of the 1563 participants included in the CLOVERS trial, 898 (57%) were included in the SHAMROC trial. As 196 were lost to follow-up, 702 participants were analyzed at 6 months (431 survivors and 271 non-survivors). Baseline characteristics were similar between the groups. At 6 months, no group differences were observed in cognitive function (restrictive versus liberal; trimmed mean difference in Montreal Cognitive Assessment-Blind Score, 0.11, 95% CI -1.44-1.70), executive function (trimmed mean difference in Hayling Sentence Completion Test, 0.38, 95% CI -0.97-1.76), disability status (trimmed mean difference in Activity of Daily Living Score, 0.03, 95% CI -0.84-0.90), mobility (trimmed mean difference in PROMIS Mobility Score, 0.72, 95% CI -2.20-3.64), and health-related quality of life (trimmed mean difference in EQ-5D-5L, -0.01, 95% CI -0.07-0.06). Outcomes also did not differ at 12 months.
CONCLUSIONS: In this long-term follow-up of a randomized controlled trial of patients with sepsis-induced hypotension, the restrictive fluid strategy used in this study resulted in similar cognitive and physical function at 6 and 12 months, compared to a liberal fluid strategy.
OBJECTIVES: To assess the effect of an early restrictive or liberal fluid resuscitation strategy on long-term functional outcomes in patients with sepsis-induced hypotension.
METHODS: SHAMROC (Sepsis-induced Hypotension: Assessing effect of Method of Resuscitation On Patient-centered Outcomes) prospectively assessed the impact of random assignment to a restrictive or liberal fluid resuscitation strategy for sepsis-induced hypotension outcomes at 6 and 12 months after randomization in the NIH NHLBI PETAL Network's CLOVERS trial (NCT03434028). The pre-specified analyses used trimmed means at 50% to prevent informative censoring of deceased patients.
MEASUREMENTS AND MAIN RESULTS: Of the 1563 participants included in the CLOVERS trial, 898 (57%) were included in the SHAMROC trial. As 196 were lost to follow-up, 702 participants were analyzed at 6 months (431 survivors and 271 non-survivors). Baseline characteristics were similar between the groups. At 6 months, no group differences were observed in cognitive function (restrictive versus liberal; trimmed mean difference in Montreal Cognitive Assessment-Blind Score, 0.11, 95% CI -1.44-1.70), executive function (trimmed mean difference in Hayling Sentence Completion Test, 0.38, 95% CI -0.97-1.76), disability status (trimmed mean difference in Activity of Daily Living Score, 0.03, 95% CI -0.84-0.90), mobility (trimmed mean difference in PROMIS Mobility Score, 0.72, 95% CI -2.20-3.64), and health-related quality of life (trimmed mean difference in EQ-5D-5L, -0.01, 95% CI -0.07-0.06). Outcomes also did not differ at 12 months.
CONCLUSIONS: In this long-term follow-up of a randomized controlled trial of patients with sepsis-induced hypotension, the restrictive fluid strategy used in this study resulted in similar cognitive and physical function at 6 and 12 months, compared to a liberal fluid strategy.