Twenty‐four‐hour fluid administration in emergency department patients with suspected infection: A multicenter, prospective, observational study

Simonsen

Acta Anaesthesiol Scand

et al. 2022

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Background: Fluid administration and resuscitation of patients with sepsis admitted through emergency departments (ED) remains a challenge, and evidence is sparse especially in sepsis patients without shock. We aimed to investigate emergency medicine physicians' and nurses' perceptions, self-reported decision-making and daily behavior, and challenges in fluid administration of ED sepsis patients. Methods: We developed and conducted a multicenter, web-based, cross-sectional survey focusing on fluid administration to ED patients with sepsis sent to all nurses and physicians from the five EDs in the Central Denmark Region. The survey consisted of three sections: (1) baseline information; (2) perceptions of fluid administration and daily practice; and (3) clinical scenarios about fluid administration. The survey was performed from February to June, 2021. Results: In total, 138 of 246 physicians (56%) and 382 of 595 nurses (64%) responded to the survey. Of total, 94% of physicians and 97% of nurses regarded fluid as an important part of sepsis treatment. Of total, 80% of physicians and 61% of nurses faced challenges regarding fluid administration in the ED, and decisions were usually based on clinical judgment. The most common challenge was the lack of guidelines for fluid administration. Of total, 96% agreed that they would like to learn more about fluid administration, and 53% requested research in fluid administration of patients with sepsis. For a normotensive patient with sepsis, 46% of physicians and 44% of nurses administered 1000 ml fluid in the first hour. Of total, 95% of physicians and 89% of nurses preferred to administer ≥1000 ml within an hour if the patients' blood pressure was 95/60 at admission. There was marked variability in responses. Blood pressure was the most commonly used trigger for fluid administration. Respondents preferred to administer less fluid if the patient in the scenario had known renal impairment or heart failure. Normal saline was the preferred fluid. Conclusion: Fluid administration is regarded as an important but challenging aspect of sepsis management. Responses to scenarios revealed variability in fluid volumes. Blood pressure was the most used trigger. ED nurses and physicians request evidence-based guidelines to improve fluid administration.

Section: Introductionmentioning

confidence: 99%

Fluid management of emergency department patients with sepsis—A survey of fluid resuscitation practices

Simonsen

Acta Anaesthesiol Scand

et al. 2022

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“…Fluid volumes in the current trial were lower than those in our previous cohort study. 4 In our sample size estimation, we assumed a Renal failure defined according to KDIGO criteria (see supplemental material).…”

Section: Discussionmentioning

confidence: 99%

“…Even in survivors, sepsis can cause permanent organ dysfunction and impaired health‐related quality of life 1,2 . Infections are common in emergency department (ED) patients accounting for up to one in four admissions, among these up to one in four with sepsis 1,3,4 …”

Section: Introductionmentioning

confidence: 99%

Restrictive fluids versus standard care in adults with sepsis in the emergency department (REFACED): A multicenter, randomized feasibility trial

Andersen

Academic Emergency Medicine

et al. 2022

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Background Fluid treatment in sepsis is a challenge and clinical equipoise exists regarding intravenous (IV) volumes. We aimed to determine whether a 24‐h protocol restricting IV fluid was feasible in adult patients with sepsis without shock presenting to the emergency department (ED). Methods The REFACED Sepsis trial is an investigator‐initiated, multicenter, randomized, open‐label, feasibility trial, assigning sepsis patients without shock to 24 h of restrictive, crystal IV fluid administration or standard care. In the IV fluid restriction group fluid boluses were only permitted if predefined criteria for hypoperfusion occurred. Standard care was at the discretion of the treating team. The primary outcome was total IV crystalloid fluid volumes at 24 h after randomization. Secondary outcomes included total fluid volumes, feasibility measures, and patient‐centered outcomes. Results We included 123 patients (restrictive 61 patients and standard care 62 patients) in the primary analysis. A total of 32% (95% confidence interval [CI] 28%–37%) of eligible patients meeting all inclusion criteria and no exclusion criteria were included. At 24 h, the mean (±SD) IV crystalloid fluid volumes were 562 (±1076) ml versus 1370 (±1438) ml in the restrictive versus standard care group (mean difference –801 ml, 95% CI −1257 to −345 ml, p = 0.001). Protocol violations occurred in 21 (34%) patients in the fluid‐restrictive group. There were no differences between groups in adverse events, use of mechanical ventilation or vasopressors, acute kidney failure, length of stay, or mortality. Conclusions A protocol restricting IV crystalloid fluids in ED patients with sepsis reduced 24‐h fluid volumes compared to standard care. A future trial powered toward patient‐centered outcomes appears feasible.

“…The trial was powered to the primary outcome of 24-h total intravenous fluids. The sample size calculation is based on data from an observational study conducted in the Central Denmark Region in which sepsis patients meeting inclusion criteria for the current trial received 2670 ml intravenous fluids (SD 1695) [ 29 ]. We therefore estimated that the total amount of IV fluid in the control group will be 2650 ml (standard deviation 1700 ml).…”

Section: Methodsmentioning

confidence: 99%

“…The effects of fluid resuscitation in sepsis are uncertain, and liberal administration may lead to overhydration and edema [ 9 , 14 – 24 ]. The choices around fluid volumes are supported by low quality of evidence, which may contribute to marked practice variation [ 9 , 25 – 29 ]. The international Surviving Sepsis Campaign (SSC) guides the treatment of sepsis associated hypotension [ 30 ], but does not give any recommendations for fluids in sepsis patients not in shock, despite the fact that sepsis is almost 60 times more frequent then septic shock [ 1 ].…”

Section: Introductionmentioning

confidence: 99%

Restrictive Fluid Administration vs. Standard of Care in Emergency Department Sepsis Patients (REFACED Sepsis)—protocol for a multicenter, randomized, clinical, proof-of-concept trial

Andersen

et al. 2022

Pilot Feasibility Stud

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Background Intravenous fluids are often used in the treatment of sepsis. The better strategy regarding fluid volume is debated, but preliminary data in patients with septic shock or sepsis-related hypotension favor restrictive fluid administration. We describe the protocol and statistical analysis plan for the Restrictive Fluid Administration vs. Standard of Care in Emergency Department Sepsis Patients (REFACED Sepsis)—a multicenter, randomized clinical proof-of-concept trial. The aim of the REFACED Sepsis trial is to test if a restrictive intravenous fluid protocol in emergency department patients with sepsis without shock is feasible and decreases the intravenous fluid volume administered in comparison to standard care. Methods This is an investigator-initiated, multicenter, randomized, parallel-group, open-labeled, feasibility trial investigating volumes of crystalloid fluid within 24 h in 124 patients with sepsis without shock enrolled at three emergency departments in the Central Denmark Region. Patients are allocated to two different intravenous fluid regimens: a restrictive approach using four trigger criteria for fluid administration vs. standard care. The primary, feasibility outcome is total intravenous, crystalloid fluid volume within 24 h, and key secondary outcomes include protocol violations, total fluids (intravenous and oral) within 24 h, and serious adverse reactions and suspected unexpected serious adverse reactions. Status: The trial started in November 2021, and the last patient is anticipated to be included in January 2022. Discussion Sepsis is very common in emergency department patients and fluid administration is very frequently administered in these patients. However, the evidence to guide fluid administration is very sparse. This feasibility trial will be the foundation for a potential future large-scale trial investigating restrictive vs. standard fluid administration in patients with sepsis. Trial registration EudraCT number: 2021-000224-35 (date: 2021 May 03), ClinicalTrials.gov number: NCT05076435 (date: 2021 October 13), Committee on Health Research Ethics – Central Denmark Region: 1-10-72-163-21 (date: 2021 June 28).