Septic ShockFRESSPEDNCT05066464
Fluid Resuscitation for Suspected Sepsis in Paediatric Emergency Departments
An observational study of Septic Shock, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 day to 18 years
- Conditions the study is for
- Septic Shock
- What is being tested?
- Fluid Resuscitation
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 29 Nov 2021to 28 Apr 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 18 years
- All sexes
- Child, Adult
Study population: Infants and children from paediatric emergency departments
Who may be able to join
- 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)
Who cannot join
- Parent (or legal guardian) objection to data collection.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Fluid Resuscitation for Suspected Sepsis in Paediatric Emergency Departments (FRESSPED): a French Multicenter Prospective Observational Study
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.
Read the detailed description
FRESSPED study was conducted over 5 weeks, the last week of each month, between November 2021 and March 2022 (11/29 - 12/05 ; 12/27 - 01/02 ; 01/24 - 30/01 ; 02/21 - 02/27 ; 03/21 - 03/27). Patients were followed up one month after inclusion, extending the study period until midnight on 28 April 2022.
FRESSPED study was conducted in three stages :
- Evaluation of usual fluid bolus therapy practice in infants and children with suspected sepsis in French paediatric emergency departments, through the prospectively anonymous completion of a paper case report form (CRF) designed to be completed in less than 5 minutes, within 72 hours of inclusion, by each doctor in one of the participating centers caring for an eligible patient
- Questioning of participating doctors at the end of the 5-week prospective data collection period, to explore the underlying reasons of doctors non-adherence to the SSC-2020 guidelines. It will take the form of a short, anonymized and blinded of centers outcomes, online survey to assess attitudes and knowledge, without inter-center or inter-individual comparisons (except for doctors seniority)
- Description of characteristics and outcomes of included patients, by consultation, up to 1 month after inclusion, of data collected in routine care (patient chart) by the lead researcher (Julian San GEROTEO).
In addition to the above criteria, the suspicion of sepsis was confirmed retrospectively in doubtful or non-documented cases or those without microbiological documentation, using an adjudication committee composed of two medical experts particularly important in the absence of a ""gold standard"" definition of paediatric sepsis to date.
- Conditions
- Septic Shock
- Being tested
- Fluid Resuscitation
- Keywords
- Paediatric sepsis, SSC-2020, fluid bolus therapy
- Medical subject headings
- Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluid ResuscitationOther
Fluid Resuscitation for Suspected Sepsis in Paediatric Emergency Departments
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 1 day
Adherence to the SSC-2020 guidelines of fluid bolus therapy according to the following indicator
Use of balanced crystalloids (yes/no)
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2021
- Study start29 Nov 2021
- Primary completion27 Mar 2022
- Study completion28 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Septic ShockStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephane DAUGER, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05066464
- Sponsor's protocol ID
- APHPHLJ
- Acronym
- FRESSPED
- Status last verified
- Sep 2021
- First submitted
- 22 Sep 2021
- Last updated
- 22 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 38499323
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fluid Resuscitation for Suspected Sepsis in Paediatric Emergency Departments (FRESSPED): a French Multicenter Prospective Observational Study
- ClinicalTrials.gov ID
- NCT05066464
- Acronym / sponsor ID
- FRESSPED / APHPHLJ
- Conditions
- Septic Shock
- Keywords
- Paediatric sepsis, SSC-2020, fluid bolus therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 29 Nov 2021 (actual)
- Primary completion
- 27 Mar 2022 (actual)
- Study completion
- 28 Apr 2022 (actual)
- First posted
- 4 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
FRESSPED study was conducted over 5 weeks, the last week of each month, between November 2021 and March 2022 (11/29 - 12/05 ; 12/27 - 01/02 ; 01/24 - 30/01 ; 02/21 - 02/27 ; 03/21 - 03/27). Patients were followed up one month after inclusion, extending the study period until midnight on 28 April 2022.
FRESSPED study was conducted in three stages :
- Evaluation of usual fluid bolus therapy practice in infants and children with suspected sepsis in French paediatric emergency departments, through the prospectively anonymous completion of a paper case report form (CRF) designed to be completed in less than 5 minutes, within 72 hours of inclusion, by each doctor in one of the participating centers caring for an eligible patient
- Questioning of participating doctors at the end of the 5-week prospective data collection period, to explore the underlying reasons of doctors non-adherence to the SSC-2020 guidelines. It will take the form of a short, anonymized and blinded of centers outcomes, online survey to assess attitudes and knowledge, without inter-center or inter-individual comparisons (except for doctors seniority)
- Description of characteristics and outcomes of included patients, by consultation, up to 1 month after inclusion, of data collected in routine care (patient chart) by the lead researcher (Julian San GEROTEO).
In addition to the above criteria, the suspicion of sepsis was confirmed retrospectively in doubtful or non-documented cases or those without microbiological documentation, using an adjudication committee composed of two medical experts particularly important in the absence of a ""gold standard"" definition of paediatric sepsis to date.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 day to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Infants and children from paediatric emergency departments
Key inclusion criteria (4 listed)
- 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.
- 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)
Key exclusion criteria (1 listed)
- Parent (or legal guardian) objection to data collection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fluid ResuscitationFluid Resuscitation for Suspected Sepsis in Paediatric Emergency Departments | Other | – |
Primary outcome
Adherence to the SSC-2020 guidelines of fluid bolus therapy according to the following indicator
Time frame: 1 day
Volume of 10ml/kg to 20ml/kg for each bolus (yes/no)
Adherence to the SSC-2020 guidelines of fluid bolus therapy according to the following indicator
Time frame: 1 day
Total volume of 40-60 ml/kg of during the first hour of sepsis recognition (yes/no)
Adherence to the SSC-2020 guidelines of fluid bolus therapy according to the following indicator
Time frame: 1 day
Use of balanced crystalloids (yes/no)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2023.
- Derived from this study: PubMed 38499323San 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.
- Individual participant dataSharing planned: Undecided
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Sepsis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephane DAUGER, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Septic Shock, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to the SSC-2020 guidelines of fluid bolus therapy according to the following indicator (time frame: 1 day). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05066464, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2023.