Plasma exchange for severely ill kids with sepsis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective randomized trial compares standard sepsis care alone to standard care plus therapeutic plasma exchange (TPE) in children with severe sepsis or septic shock admitted to a PICU. Participants are randomized to receive daily TPE sessions (1–5 sessions) within 24 hours of diagnosis, using 1-1.5 plasma volumes per session with fresh frozen plasma replacement. Outcomes include organ dysfunction (pSOFA), duration of vasopressors, PICU length of stay, time to hemodynamic stabilization, and inflammatory/coagulation biomarkers. The study is open-label and conducted at Menoufia University Hospital's PICU between August 2026 and February 2027. Adverse events from TPE will be monitored and managed per PICU protocols.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. From one month to 18 years.
2. With an established diagnosis of severe sepsis or septic shock according to international pediatric sepsis definitions.

Exclusion Criteria:

1. Known congenital bleeding disorders and severe uncontrolled hemorrhage.
2. End-stage chronic illness with expected survival \< 3 months.
3. Previous plasma exchange during the same admission.
4. Contraindications to central venous catheterization.

Where it's running

• Menoufia university hospital, Pediatric intensive care unit
  Shibīn al Kawm, Menoufia Governorate, Egypt Recruiting

Study contacts

• Principal investigator: Hani Hamed Saad, MD, pediatrics — Faculty of medicine, Menoufia University
• Study coordinator: Hani Hamed Saad, MD, Pediatrics
• Email: hani.hamed870@med.menofia.edu.eg
• Phone: +201067610619

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.