NCT07706413

Brief 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

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
8mo left

Started Aug 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 2, 2026

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 15, 2026

Completed
17 days until next milestone

Study Start

First participant enrolled

August 1, 2026

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2027

Last Updated

July 15, 2026

Status Verified

July 1, 2026

Enrollment Period

7 months

First QC Date

July 2, 2026

Last Update Submit

July 13, 2026

Conditions

Severe Sepsis

Keywords

Plasma exchangesevere sepsisseptic shockchildernRandomized controlled trial

Outcome Measures

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.

    28 days

Secondary Outcomes (10)

  • Change in pediatric Sequential Organ Failure Assessment (pSOFA) score

    Baseline, Day 1, Day 3, and Day 7

  • Duration of vasopressor support

    Up to 28 days

  • Length of pediatric intensive care unit (PICU) stay

    Up to 28 days

  • Time to shock resolution

    Up to 28 days

  • Change in C-reactive protein (CRP)

    Baseline, Day 3, and Day 7

  • +5 more secondary outcomes

Study Arms (1)

Intervention Group (plasma exchange Arm)

ACTIVE COMPARATOR

this arm will receive standard sepsis management plus therapeutic plasma exchange.

Procedure: Plasma exchange (PE)

Interventions

Plasma exchange (PE)PROCEDURE

Therapeutic plasma exchange to the intervention Group (plasma exchange Arm) that will receive also the standard sepsis management.

Intervention Group (plasma exchange Arm)

Eligibility Criteria

Age1 Month - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Menoufia university hospital, Pediatric intensive care unit

Shibīn al Kawm, Menoufia Governorate, Egypt

Location

Related Links

MeSH Terms

Conditions

SepsisShock, Septic

Interventions

Plasma Exchange

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShock

Intervention Hierarchy (Ancestors)

Blood TransfusionBiological TherapyTherapeuticsPlasmapheresisBlood Component RemovalSorption DetoxificationExtracorporeal CirculationSurgical Procedures, Operative

Study Officials

  • Hani Hamed Saad, MD, pediatrics

    Faculty of medicine, Menoufia University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hani Hamed Saad, MD, Pediatrics

CONTACT

+201067610619hani.hamed870@med.menofia.edu.eg

Nagwan Yossery Saleh, MD, Pediatrics

CONTACT

+201003961071drnagwan80@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: The study population will be divided into two groups( two arms) , the first group will receive standard sepsis management plus therapeutic plasma exchange and the second one will receive the standard sepsis management alone.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of pediatrics at Faculty of medicine , Menoufia university

Study Record Dates

First Submitted

July 2, 2026

First Posted

July 15, 2026

Study Start

August 1, 2026

Primary Completion (Estimated)

February 28, 2027

Study Completion (Estimated)

March 31, 2027

Last Updated

July 15, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)