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Fluid Bolus Therapy in Pediatric Sepsis: Current Knowledge and Future Direction.

ABSTRACT: Sepsis is a leading cause of morbidity and mortality in children with a worldwide prevalence in pediatric intensive care units of approximately 8%. Fluid bolus therapy (FBT) is a first line therapy for resuscitation of septic shock and has been a recommendation of international guidelines for nearly two decades. The evidence base supporting these guidelines are based on limited data including animal studies and case control studies. In recent times, evidence suggesting harm from fluid in terms of morbidity and mortality have generated interest in evaluating FBT. In view of this, studies of fluid restrictive strategies in adults and children have emerged. The complexity of studying FBT relates to several points. Firstly, the physiological and haemodynamic response to FBT including magnitude and duration is not well described in children. Secondly, assessment of the circulation is based on non-specific clinical signs and limited haemodynamic monitoring with limited physiological targets. Thirdly, FBT exists in a complex myriad of pathophysiological responses to sepsis and other confounding therapies. Despite this, a greater understanding of the role of FBT in terms of the physiological response and possible harm is warranted. This review outlines current knowledge and future direction for FBT in sepsis.

SUBMITTER: Gelbart B

PROVIDER: S-EPMC6209667 | biostudies-literature | 2018

REPOSITORIES: biostudies-literature

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Fluid Bolus Therapy in Pediatric Sepsis: Current Knowledge and Future Direction.

Gelbart Ben B

Frontiers in pediatrics 20181025

Sepsis is a leading cause of morbidity and mortality in children with a worldwide prevalence in pediatric intensive care units of approximately 8%. Fluid bolus therapy (FBT) is a first line therapy for resuscitation of septic shock and has been a recommendation of international guidelines for nearly two decades. The evidence base supporting these guidelines are based on limited data including animal studies and case control studies. In recent times, evidence suggesting harm from fluid in terms o ...[more]

PMID: 30410875

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Project description:Background/aimsDespite evidence that preferential use of balanced/buffered fluids may improve outcomes compared with chloride-rich 0.9% saline, saline remains the most commonly used fluid for children with septic shock. We aim to determine if resuscitation with balanced/buffered fluids as part of usual care will improve outcomes, in part through reduced kidney injury and without an increase in adverse effects, compared to 0.9% saline for children with septic shock.MethodsThe Pragmatic Pediatric Trial of Balanced versus Normal Saline Fluid in Sepsis (PRoMPT BOLUS) study is an international, open-label pragmatic interventional trial being conducted at > 40 sites in the USA, Canada, and Australia/New Zealand starting on August 25, 2020, and continuing for 5 years. Children > 6 months to < 18 years treated for suspected septic shock with abnormal perfusion in an emergency department will be randomized to receive either balanced/buffered crystalloids (intervention) or 0.9% saline (control) for initial resuscitation and maintenance fluids for up to 48 h. Eligible patients are enrolled and randomized using serially numbered, opaque envelopes concurrent with clinical care. Given the life-threatening nature of septic shock and narrow therapeutic window to start fluid resuscitation, patients may be enrolled under "exception from informed consent" in the USA or "deferred consent" in Canada and Australia/New Zealand. Other than fluid type, all decisions about timing, volume, and rate of fluid administration remain at the discretion of the treating clinicians. For pragmatic reasons, clinicians will not be blinded to study fluid type. Anticipated enrollment is 8800 patients. The primary outcome will be major adverse kidney events within 30 days (MAKE30), a composite of death, renal replacement therapy, and persistent kidney dysfunction. Additional effectiveness, safety, and biologic outcomes will also be analyzed.DiscussionPRoMPT BOLUS will provide high-quality evidence for the comparative effectiveness of buffered/balanced crystalloids versus 0.9% saline for the initial fluid management of children with suspected septic shock in emergency settings.Trial registrationPRoMPT BOLUS was first registered at ClinicalTrials.gov ( NCT04102371 ) on September 25, 2019. Enrollment started on August 25, 2020.

Project description:BackgroundResuscitation with crystalloid fluid is a cornerstone of pediatric septic shock treatment. However, the optimal type of crystalloid fluid is unknown. We aimed to determine the feasibility of conducting a pragmatic randomized trial to compare balanced (lactated Ringer's [LR]) with 0.9% normal saline (NS) fluid resuscitation in children with suspected septic shock.MethodsOpen-label pragmatic randomized controlled trial at a single academic children's hospital from January to August 2018. Eligible patients were >6 months to <18 years old who were treated in the emergency department for suspected septic shock, operationalized as blood culture, parenteral antibiotics, and fluid resuscitation for abnormal perfusion. Screening, enrollment, and randomization were carried out by the clinical team as part of routine care. Patients were randomized to receive either LR or NS for up to 48 hours following randomization. Other than fluid type, all treatment decisions were at the clinical team's discretion. Feasibility outcomes included proportion of eligible patients enrolled, acceptability of enrollment via the U.S. federal exception from informed consent (EFIC) regulations, and adherence to randomized study fluid administration.ResultsOf 59 eligible patients, 50 (85%) were enrolled and randomized. Twenty-four were randomized to LR and 26 to NS. Only one (2%) of 44 patients enrolled using EFIC withdrew before study completion. Total median (interquartile range [IQR]) crystalloid fluid volume received during the intervention window was 107 (60 to 155) mL/kg and 98 (63 to 128) mL/kg in the LR and NS arms, respectively (p = 0.50). Patients randomized to LR received a median (IQR) of only 20% (13 to 32) of all study fluid as NS compared to 99% (64% to 100%) of study fluid as NS in the NS arm (absolute difference = 79%, 95% CI = 48% to 85%).ConclusionsA pragmatic study design proved feasible to study comparative effectiveness of LR versus NS fluid resuscitation for pediatric septic shock.

Dataset Information

Fluid Bolus Therapy in Pediatric Sepsis: Current Knowledge and Future Direction.

Publications

Fluid Bolus Therapy in Pediatric Sepsis: Current Knowledge and Future Direction.

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