Sepsis/Septic shock Infections and Infestations Sepsis/Septic shock
Conditions
Interventions
Patients are randomised 1:1 using sealed opaque envelopes available at each site.
Intervention: Restrictive bolus fluid resuscitation of 10 ml/kg (maximum 500 ml per bolus)
Control: Current recommend
Sponsors
Imperial College Heathcare NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Pilot RCT: Children: 1. Age greater than or equal to 37 weeks (corrected gestational age) and less than 16 years 2. Clinical suspicion of infection 3. Clinical signs of shock after receipt of 20 ml/kg of bolus fluid 4. Recruitment and randomisation to take place while child is in an acute assessment area (e.g. emergency department, paediatric assessment unit (PAU)) Observational component: Parent/Guardian inclusion criteria (questionnaire component): Parent/Guardians who were approached for consent prior to hospital discharge Parent/Guardian inclusion criteria (telephone interview component): Parent/Guardians who were approached for consent Site research staff: Site research staff who are involved in screening, recruiting, randomising and consenting during the pilot RCT.
Exclusion criteria
Exclusion criteria: Pilot RCT: Children: 1. Prior receipt of more than 20 ml/kg of bolus fluid 2. Conditions in which bolus fluid resuscitation should be curtailed (e.g. raised intracranial pressure, diabetic ketoacidosis, known/suspected myocarditis/cardiomyopathy) 3. Full active resuscitation not within current goals of care Observational component: Parent/Guardian exclusion criteria (questionnaire and telephone interview): Parents/Guardians who do not speak English.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility of the intervention processes is determined by the evaluation of all the secondary outcomes at the end of the study, including a recommendation, or not, to continue to a larger trial. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Eligibility rate is measured using the proportion of eligible patients randomised, as recorded on the screening and enrolment log at baseline 2. Recruitment rate is measured using the number of patients randomised per site per month, as recorded on the enrolment log and study database at baseline 3. Proportion of parents/guardians refusing deferred consent is measured using data recorded on the enrolment log and study database at hospital discharge or end of study (dependent upon timing of approach) 4. Proportion of fluid boluses delivered at correct volume and time during the intervention period is measured using data recorded on patient medical notes and the study database between randomisation and four hours post-randomisation 5. Total volume of fluid received during the intervention period is measured using data recorded on patient medical notes and the study database between randomisation and four hours post-randomisation 6. Proportion of complete data for each outcome measure is measured using data recorded on patient medical notes, the study database and linkage with routine data sources between randomisation and 30 days post-randomisation 7. Time taken for data collection and entry is measured using data from feedback from site staff during focus groups at the end of the study 8. Proportion of required data able to be linked to routine sources is measured using routine sources specification at the end of the study 9. Adverse events are measured using data recorded on patient medical notes and the study database between randomisation and 30 days post-randomisation | — |
Countries
England, United Kingdom
Contacts
Public ContactRuth Canter
Outcome results
None listed