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

21. august 2026 opdateret af: Hani Hamed Saad, Menoufia University

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

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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).

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

22

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

  • Navn: Nagwan Yossery Saleh, MD, pediatrics
  • Telefonnummer: +201003961071
  • E-mail: drnagwan80@gmail.com

Studiesteder

  • Egypten
    • Menoufia Governorate
      • Shibīn al Kawm, Menoufia Governorate, Egypten
        • Rekruttering
        • Menoufia university hospital, Pediatric intensive care unit
        • Kontakt:
        • Kontakt:
        • Ledende efterforsker:
          • Hani Hamed Saad, MD, pediatrics
        • Underforsker:
          • Nagwan Yossery Saleh, MD, pediatrics
        • Underforsker:
          • Amira Zaki Badawy, MD, clinical pathology

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Primary Outcome Measure
Tidsramme: 28 days
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

Sekundære resultatmål

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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Menoufia University

Efterforskere

  • Ledende efterforsker: Hani Hamed Saad, MD, pediatrics, Faculty of medicine, Menoufia University

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. august 2026

Primær færdiggørelse (Anslået)

28. februar 2027

Studieafslutning (Anslået)

31. marts 2027

Datoer for studieregistrering

Først indsendt

2. juli 2026

Først indsendt, der opfyldte QC-kriterier

13. juli 2026

Først opslået (Faktiske)

15. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

24. august 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

21. august 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 3/2026 PEDI 3

Plan for individuelle deltagerdata (IPD)

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INGEN

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