Plasma Exchange in Children With Severe Sepsis and Septic Shock
ConditionSevere Sepsis
Trial statusNot yet recruiting
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
Qualifiers
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
Treatments tested in this trial
- Plasma exchange (PE)
Treatment groups
22 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov