Plasma Exchange in Children With Severe Sepsis and Septic Shock
NCT07706413 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 22
Last updated 2026-08-24
Summary
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
Conditions
- Severe Sepsis
Interventions
- PROCEDURE
-
Plasma exchange (PE)
Therapeutic plasma exchange to the intervention Group (plasma exchange Arm) that will receive also the standard sepsis management.
Sponsors & Collaborators
-
Menoufia University
lead OTHER
Principal Investigators
-
Hani Hamed Saad, MD, pediatrics · Faculty of medicine, Menoufia University
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 1 Month
- Max Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-08-01
- Primary Completion
- 2027-02-28
- Completion
- 2027-03-31
Countries
- Egypt
Study Locations
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