Plasma Exchange in Children With Severe Sepsis and Septic Shock (PE/Sepsis)

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

Study Overview

• Status: Not yet recruiting
• Conditions: Severe Sepsis
• Intervention / Treatment: Procedure: Plasma exchange (PE)

Detailed Description

This will be a Prospective, randomized, controlled, open- label, parallel-group, center clinical trial, which will be conducted on critically ill children with severe sepsis and septic shock, admitted into the Pediatric Intensive Care Unit (PICU) of Menoufia University Hospital from August 2026 to February 2027.

Eligible patients will be randomized using a computer-generated random sequence into:

1. - Intervention Group (plasma exchange Arm): Standard sepsis management plus therapeutic plasma exchange.
2. - Control Group (Standard care Arm): Standard sepsis management alone. Interventions

Standard Care (Both Groups):

1. - Early antimicrobial therapy
2. - Fluid resuscitation.
3. - Vasopressor and inotropic support
4. - Mechanical ventilation as indicated

5. - Organ support according to PICU protocols Therapeutic Plasma Exchange (TPE) Protocol

   • Initiation: Within 24 hours of diagnosis.
   • Frequency: Once daily for 1-5 sessions (Connelly et al.,2023)
   • Plasma Volume: 1-1.5 plasma volumes per session.
   • Replacement Fluid: Fresh frozen plasma (FFP).
   • Anticoagulation: Citrate or heparin according to institutional protocol.
   • Monitoring: Continuous hemodynamic and laboratory monitoring (All adverse events related to TPE (hypotension, bleeding, electrolyte disturbances, allergic reactions) will be recorded and managed according to PICU protocols.

All patients will be subjected to:

1. Demographic data will be collected from each participant, including age, sex, and weight, height, and body mass index.

2. Clinical Assessment:

   • Detailed history and physical examination.
   • Scoring of the severity of the disease using pSOFA (Pediatric Sequential Organ Failure Assessment) and PELOD-2 (Pediatric Logistic Organ Dysfunction 2) scores.
3. Laboratory investigations:

1) - Complete blood count (CBC). 2) - C-reactive protein (CRP). 3) - Procalcitonin (PCT). 4) - Coagulation profile (PT, aPTT and INR). 5) - Liver functions (ALT and AST). 6) - Kidney functions (Urea and creatinine). 7) - Electrolytes: Sodium (Na), potassium (K) and Calcium (Ca) levels. 8) - Serum lactate level and LDH. 9) - Blood cultures for all cases, urine and CSF culture (if indicated).

• Study Type: Interventional
• Enrollment (Estimated): 22
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hani Hamed Saad, MD, pediatrics; Phone Number: +201067610619; Email: hani.hamed870@med.menofia.edu.eg
• Study Contact Backup: Name: Nagwan Yossery Saleh, MD, pediatrics; Phone Number: +201003961071; Email: drnagwan80@gmail.com

Study Locations

• Egypt
  • Menoufia Governorate
    • Shibīn al Kawm, Menoufia Governorate, Egypt
      • Menoufia university hospital, Pediatric intensive care unit
      • Contact: Hani Hamed Saad, MD, pediatrics; Phone Number: +201067610619; Email: hani.hamed870@med.menofia.edu.eg
      • Contact: Nagwan Yossery Saleh, MD, pediatrics; Phone Number: +201003961071; Email: drnagwan80@gmail.com
      • Principal Investigator: Hani Hamed Saad, MD, pediatrics
      • Sub-Investigator: Nagwan Yossery Saleh, MD, pediatrics
      • Sub-Investigator: Amira Zaki Badawy, MD, clinical pathology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intervention Group (plasma exchange Arm); this arm will receive standard sepsis management plus therapeutic plasma exchange.	Procedure: Plasma exchange (PE); Therapeutic plasma exchange to the intervention Group (plasma exchange Arm) that will receive also the standard sepsis management.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in pediatric Sequential Organ Failure Assessment (pSOFA) score	Change in pSOFA score from baseline measured on days 1, 3, and 7 after randomization.	Baseline, Day 1, Day 3, and Day 7
Duration of vasopressor support	Number of days participants require vasopressor support after randomization.	Up to 28 days
Length of pediatric intensive care unit (PICU) stay	Number of days participants remain admitted to the PICU.	Up to 28 days
Time to shock resolution	Time from randomization until resolution of septic shock	Up to 28 days
Change in C-reactive protein (CRP)	Change in serum CRP concentration from baseline.	Baseline, Day 3, and Day 7
Change in procalcitonin concentration	Change in serum procalcitonin concentration from baseline.	Baseline, Day 3, and Day 7
Platelet count	Change in platelet count from baseline.	Baseline, Day 3, and Day 7
International normalized ratio (INR)	Change in INR from baseline.	Baseline, Day 3, and Day 7
Fibrinogen concentration	Change in plasma fibrinogen concentration from baseline.	Baseline, Day 3, and Day 7
Incidence of therapeutic plasma exchange-related adverse events	Number of participants experiencing adverse events related to therapeutic plasma exchange.	Up to 28 days

Collaborators and Investigators

• Sponsor: Menoufia University
• Investigators: Principal Investigator: Hani Hamed Saad, MD, pediatrics, Faculty of medicine, Menoufia University

Publications and helpful links

Helpful Links

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Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): March 31, 2027

Study Registration Dates

• First Submitted: July 2, 2026
• First Submitted That Met QC Criteria: July 13, 2026
• First Posted (Actual): July 15, 2026

Study Record Updates

• Last Update Posted (Actual): July 15, 2026
• Last Update Submitted That Met QC Criteria: July 13, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: septic shock; Randomized controlled trial; severe sepsis; Plasma exchange; childern
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Shock; Pathological Conditions, Signs and Symptoms; Sepsis; Shock, Septic; Therapeutics; Surgical Procedures, Operative; Biological Therapy; Blood Component Removal; Blood Transfusion; Plasmapheresis; Sorption Detoxification; Extracorporeal Circulation; Plasma Exchange
• Other Study ID Numbers: 3/2026 PEDI 3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No