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Therapeutic Plasma Exchange in Children With Severe Sepsis and Septic Shock: A Randomized Controlled Clinical Trial

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 1 month
Maximum Age: 18
Healthy Volunteers: f
View:

• From one month to 18 years.

• With an established diagnosis of severe sepsis or septic shock according to international pediatric sepsis definitions.

Locations
Other Locations
Egypt
Menoufia university hospital, Pediatric intensive care unit
RECRUITING
Shibīn Al Kawm
Contact Information
Primary
Hani Hamed Saad, MD, Pediatrics
hani.hamed870@med.menofia.edu.eg
+201067610619
Backup
Nagwan Yossery Saleh, MD, Pediatrics
drnagwan80@gmail.com
+201003961071
Time Frame
Start Date: 2026-08-01
Estimated Completion Date: 2027-03-31
Participants
Target number of participants: 22
Treatments
Active_comparator: Intervention Group (plasma exchange Arm)
this arm will receive standard sepsis management plus therapeutic plasma exchange.
Related Therapeutic Areas
Sponsors
Leads: Menoufia University

This content was sourced from clinicaltrials.gov

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