Plasma Exchange in Children With Severe Sepsis and Septic Shock
ConditionSevere Sepsis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-18
SponsorMenoufia University
About this trial
The aim of the study will be to to evaluate whether therapeutic plasma exchange (TPE) reduces mortality in critically ill children with severe sepsis or septic shock compared to the standard care of sepsis alone.
The study population will be divided into two groups, the first group will receive standard sepsis management plus therapeutic plasma exchange and the second one will receive the standard sepsis management alone . Then we will assess the effect of TPE on : Severity of organ dysfunction (pSOFA score) , duration of vasopressor support , length of PICU stay, time to hemodynamic stabilization , and on inflammatory and coagulation biomarkers
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
From one month to 18 years.
With an established diagnosis of severe sepsis or septic shock according to international pediatric sepsis definitions.
Disqualifiers
Known congenital bleeding disorders and severe uncontrolled hemorrhage.
End-stage chronic illness with expected survival < 3 months.
Previous plasma exchange during the same admission.
Contraindications to central venous catheterization.
Trial design
Design model
Single group
Treatments tested in this trial
Plasma exchange (PE)
Procedure/SurgeryTherapeutic plasma exchange to the intervention Group (plasma exchange Arm) that will receive also the standard sepsis management.
Treatment groups
22 Participants
are divided into 1 treatment groupGroup A: Intervention Group (plasma exchange Arm)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Primary Outcome Measure
All-cause mortality within 28 days after randomization, defined as the proportion of participants who die from any cause within 28 days of enrollment.
Time frame
28 daysSecondary outcomes
1
Change in pediatric Sequential Organ Failure Assessment (pSOFA) score
Change in pSOFA score from baseline measured on days 1, 3, and 7 after randomization.
Time frame
Baseline, Day 1, Day 3, and Day 72
Duration of vasopressor support
Number of days participants require vasopressor support after randomization.
Time frame
Up to 28 days3
Length of pediatric intensive care unit (PICU) stay
Number of days participants remain admitted to the PICU.
Time frame
Up to 28 days4
Time to shock resolution
Time from randomization until resolution of septic shock
Time frame
Up to 28 daysSponsors and contacts
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Source ClinicalTrials.gov