Fluid Resuscitation for Suspected Sepsis in Paediatric Emergency Departments

NCT05066464 | Completed

• 1 other identifier: APHPHLJ
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

With 25.2 million children affected and 3.4 million deaths in 2017, paediatric sepsis is the leading cause of under-five mortality worldwide and has recently been described as "significant global health threat" by the World Health Organization. In addition to early antibiotics, fluid bolus therapy (FBT) is one of the cornerstones of management, due to the theoretical improvement of cardiac output, oxygen delivery and organ perfusion. In the absence of a consensual and operational definition to date, the latest international guidelines of the Surviving Sepsis Campaign 2020 (SSC-2020), refers to children (≥ 37 weeks gestation at birth to 18 years old) with severe infection leading to cardiovascular (i.e., "septic shock") or non-cardiovascular organ dysfunction (i.e., "other sepsis-associated organ dysfunction" or former "severe sepsis"). The SSC-2020 specifies the modalities for paediatric sepsis management, particularly concerning FBT, with, for example, the preferential use of balanced crystalloids, and a target volume of 40-60ml/kg at one hour of recognition using boluses of 10-20ml/kg in children who have access to a paediatric intensive care unit (PICU) in their health system. Further, it is now well established that compliance with international guidelines is associated with improved outcomes in paediatric sepsis. Despite the importance of awareness and implementation of the SSC-2020, there are, to our knowledge, no studies evaluating its application in children. We prospectively conducted the Fluid Resuscitation for Suspected Sepsis in Paediatric Emergency Departments (FRESSPED) study in 25 hospitals over five weeks between November 2021 and March 2022, whose principal objective was to assess doctors adherence to the SSC-2020 guidelines when performing FBT in infants and children with suspected sepsis in French paediatric emergency departments.

Conditions

Septic Shock

Keywords

Paediatric sepsis, SSC-2020, fluid bolus therapy

Outcome Measures

Primary Outcomes (3)

• Adherence to the SSC-2020 guidelines of fluid bolus therapy according to the following indicator

  Volume of 10ml/kg to 20ml/kg for each bolus (yes/no)

  1 day

• Adherence to the SSC-2020 guidelines of fluid bolus therapy according to the following indicator

  Total volume of 40-60 ml/kg of during the first hour of sepsis recognition (yes/no)

  1 day

• Adherence to the SSC-2020 guidelines of fluid bolus therapy according to the following indicator

  Use of balanced crystalloids (yes/no)

  1 day

Interventions

Fluid Resuscitation OTHER

Fluid Resuscitation for Suspected Sepsis in Paediatric Emergency Departments

Eligibility Criteria

• Age: 1 Day - 18 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Infants and children from paediatric emergency departments

You may qualify if:

• Newborns (discharged from the maternity ward after full-term birth or over 39 SA corrected age) and children (under 18 years of age) admitted to the UAS of a participating center during the study period.
• Suspected sepsis according to the American Academy of Pediatrics criteria (at least 3 of the 8 criteria or 2 if high-risk patient\* among dysthermia, hypotension, tachycardia, polypnea, abnormalities in CRT, pulse rate, skin and neurological examination) and blood cultures or anti-infectives prescribed within 72 hours.
• \* Cancer, severe encephalopathy (non walking, non communicating), central line and immunosuppression (marrow or organ transplantation, asplenia including sickle cell disease, neutropenia, constitutional immune deficiency\&) immunosuppressive or immunomodulatory treatment including corticoids within 6 months)
• Having received at least one RV (at least 5ml/kg of crystalloids or colloids in less than 60 min or of 60 min or identified as such in the patient's medical record)

You may not qualify if:

• Parent (or legal guardian) objection to data collection.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Robert Debre Hospital

Paris, 75019, France

Location

Related Publications (1)

• San Geroteo J, Levy M, Bailhache M, De Jorna C, Privat E, Gasmi O, Fuentes-Lopez M, Laoudi Y, Mazeghrane M, Malterre A, Bories P, Abdel Aal K, Arjoca I, Gaschignard J, Tanchaleune D, Minodier P, Audren F, Mazetier T, Quagliaro P, Raimond F, Sieng S, Robert B, Wohrer D, De Suremain N, Dauger S. Assessment of adherence to the 2020 Surviving Sepsis Campaign guidelines for fluid resuscitation in children with suspected septic shock in paediatric emergency departments: a prospective multicentre study. Arch Dis Child. 2024 Jul 18;109(8):636-641. doi: 10.1136/archdischild-2023-325837.

  PMID: 38499323 DERIVED

MeSH Terms

Conditions

Shock, Septic

Condition Hierarchy (Ancestors)

Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Officials

• Stephane DAUGER, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2021
• First Posted: October 4, 2021
• Study Start: November 29, 2021
• Primary Completion: March 27, 2022
• Study Completion: April 28, 2022
• Last Updated: November 22, 2023

Record last verified: 2021-09

Locations

FR (1)