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A Double-Blind, Randomized Control Trial of Rapidly Infused High Strong Ion Difference (SID) Fluid Versus Hartmann’s Solution on Acid-Base Status in Sepsis Patients in the Emergency Department

ABSTRACT: Background Balanced fluids are preferred in initial resuscitation of septic patients based on several recent studies. The Stewart’s concept on acid-base balance predicts that high strong ion difference (SID) fluid thus will increase the pH level. To date, the impact of high SID fluid in septic patient with metabolic acidosis remains uncertain. We conducted single center, randomized, double-blind trial to compare the effect of high SID fluid vs. Hartmann’s solution on acid-base status in selected sepsis patients in the Emergency Department. Methods Septic patient with hyperlactatemia and metabolic acidosis were randomized to receive either high SID fl uid or Hartmann’s solution during initial fl uid resuscitation. The primary outcome measures the pH and bicarbonate levels difference pre- and post- resuscitation. Results One hundred and sixty-two patients underwent randomization, 81 were assigned each to receive high SID fluid or Hartmann’s solution. Both groups had similar baseline characteristics. High SID group received 23.5 mL/kg and the Hartmann’s group received 22.7 mL/kg (p = 0.360). High SID fluid increased the mean (± SD) pH by 0.107 (± 0.09) vs. Hartmann’s solution by 0.014 (± 0.12), p ? 0.001. Mean bicarbonate level increased signifi cantly in high SID group compared to Hartmann’s (4.30 ± 3.76 vs. 1.25 ± 3.33, p ? 0.001). High SID group had higher post resuscitation lactate clearance than Hartmann’s group (25.4 ± 28.3% vs. 12.0 ± 34.1%, p = 0.009). Shorter hospital stay was observed in highSID group 8.04 ± 5.96 days vs. Hartmann’s group 12.18 ± 12.41 days (p = 0.048). Both groups showed no difference in incidence of pulmonary oedema, acute kidney injury and mortality. Conclusions Initial resuscitation using high SID fluid in selected septic patient improves pH and bicarbonate levels. The high SID group had better post resuscitation lactate clearance and shorter hospital stay.

SUBMITTER: Yeoh C

PROVIDER: S-EPMC7440369 | biostudies-literature | 2019 Sep

REPOSITORIES: biostudies-literature

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Project description:BackgroundIntravenous 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.MethodsThis 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.DiscussionSepsis 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 registrationEudraCT 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).

Project description:BackgroundEarly intravenous fluids for patients with sepsis presenting with hypoperfusion or shock in the emergency department remains one of the key recommendations of the Surviving Sepsis Campaign guidelines to reduce mortality. However, compliance with the recommendation remains poor. While several interventions have been implemented to improve early fluid administration as part of sepsis protocols, the extent to which they have improved compliance with fluid resuscitation is unknown. The factors associated with the lack of compliance are also poorly understood.MethodsWe conducted a systematic review, meta-analysis and narrative review to investigate the effectiveness of interventions in emergency departments in improving compliance with early fluid administration and examine the non-interventional facilitators and barriers that may influence appropriate fluid administration in adults with sepsis. We searched MEDLINE Ovid/PubMed, Ovid EMBASE, CINAHL, and SCOPUS databases for studies of any design to April 2021. We synthesised results from the studies reporting effectiveness of interventions in a meta-analysis and conducted a narrative synthesis of studies reporting non-interventional factors.ResultsWe included 31 studies out of the 825 unique articles identified in the systematic review of which 21 were included in the meta-analysis and 11 in the narrative synthesis. In meta-analysis, interventions were associated with a 47% improvement in the rate of compliance [(Random Effects (RE) Relative Risk (RR) = 1.47, 95% Confidence Interval (CI), 1.25-1.74, p-value < 0.01)]; an average 24 min reduction in the time to fluids [RE mean difference = - 24.11(95% CI - 14.09 to - 34.14 min, p value < 0.01)], and patients receiving an additional 575 mL fluids [RE mean difference = 575.40 (95% CI 202.28-1353.08, p value < 0.01)]. The compliance rate of early fluid administration reported in the studies included in the narrative synthesis is 48% [RR = 0.48 (95% CI 0.24-0.72)].ConclusionPerformance improvement interventions improve compliance and time and volume of fluids administered to patients with sepsis in the emergency department. While patient-related factors such as advanced age, co-morbidities, cryptic shock were associated with poor compliance, important organisational factors such as inexperience of clinicians, overcrowding and inter-hospital transfers were also identified. A comprehensive understanding of the facilitators and barriers to early fluid administration is essential to design quality improvement projects.Prospero registration idCRD42021225417.

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A Double-Blind, Randomized Control Trial of Rapidly Infused High Strong Ion Difference (SID) Fluid Versus Hartmann’s Solution on Acid-Base Status in Sepsis Patients in the Emergency Department

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