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RecruitingNCT07706413PE/SepsisUpdated Oct 7, 2026

Plasma Exchange in Children With Severe Sepsis and Septic Shock

An interventional study of Plasma exchange (PE) in Severe Sepsis, sponsored by Menoufia University. Recruiting at 1 site in Egypt. Open to participants aged 1 Month to 18 Years. Per ClinicalTrials.gov, last updated 2026-10-07.

Primary conditionShock, SepticRegistry: SepsisReclassifiedWhy we changed it
Registry
Sepsis — the first condition term the registry derived for this study.
ClinicalTrials.gg
Shock, Septic
Why
  1. The study's title name Shock, Septic, a narrower term within Sepsis.
Confidence
High: the new condition is named in the study's own title. Of 46 hand-checked studies reclassified this way, 72% were exactly right and 89% in the right disease family; the registry's first term was right for 4% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Menoufia University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Aug 2026; still recruiting 3 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
22
Allocation
Not applicable
Ages
1 Month to 18 Years
Sex
All
01

Study 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

Read the 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).

02

Conditions studied

  • Severe Sepsis

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Keywords

  • Plasma exchange
  • severe sepsis
  • septic shock
  • childern
  • Randomized controlled trial
03

In context

Shock, Septic Reclassified

1,078 studies on the registry are indexed under Shock, Septic; 232 are open to participants now.

This study's planned enrollment of 22 is below the median of 79 across 636 interventional studies indexed under Shock, Septic.

Browse Shock, Septic studies →

Lead sponsor

Menoufia University is the lead sponsor of 199 studies on the registry; 54 are open to participants now.

Browse Menoufia University studies →

Compared within Shock, Septic, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Sepsis. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
1 Month to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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. to central venous catheterization.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
22 participants (estimated)

Study arms

  • Active comparator
    Intervention Group (plasma exchange Arm)

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

    Procedure: Plasma exchange (PE)

Interventions

  • ProcedurePlasma exchange (PE)

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

06

What researchers measure

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.

    Time frame: 28 days

Secondary outcomes

  1. Change in pediatric Sequential Organ Failure Assessment (pSOFA) score

    Change in pSOFA score from baseline measured on days 1, 3, and 7 after randomization.

    Time frame: Baseline, Day 1, Day 3, and Day 7

  2. Duration of vasopressor support

    Number of days participants require vasopressor support after randomization.

    Time frame: Up to 28 days

  3. Length of pediatric intensive care unit (PICU) stay

    Number of days participants remain admitted to the PICU.

    Time frame: Up to 28 days

  4. Time to shock resolution

    Time from randomization until resolution of septic shock

    Time frame: Up to 28 days

  5. Change in C-reactive protein (CRP)

    Change in serum CRP concentration from baseline.

    Time frame: Baseline, Day 3, and Day 7

  6. Change in procalcitonin concentration

    Change in serum procalcitonin concentration from baseline.

    Time frame: Baseline, Day 3, and Day 7

  7. Platelet count

    Change in platelet count from baseline.

    Time frame: Baseline, Day 3, and Day 7

  8. International normalized ratio (INR)

    Change in INR from baseline.

    Time frame: Baseline, Day 3, and Day 7

  9. Fibrinogen concentration

    Change in plasma fibrinogen concentration from baseline.

    Time frame: Baseline, Day 3, and Day 7

  10. Incidence of therapeutic plasma exchange-related adverse events

    Number of participants experiencing adverse events related to therapeutic plasma exchange.

    Time frame: Up to 28 days

07

Study locations

1 of 1 sites recruiting
  • Menoufia university hospital, Pediatric intensive care unit
    Shibīn al Kawm, Menoufia Governorate, Egypt
    Recruiting
    • Hani Hamed Saad, MD, pediatrics · Contacthani.hamed870@med.menofia.edu.eg · +201067610619
    • Nagwan Yossery Saleh, MD, pediatrics · Contactdrnagwan80@gmail.com · +201003961071
    • Hani Hamed Saad, MD, pediatrics · Principal investigator
    • Nagwan Yossery Saleh, MD, pediatrics · Sub investigator
    • Amira Zaki Badawy, MD, clinical pathology · Sub investigator
08

References and documents

Individual participant data

Plan to share: No

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Aug 2026 (actual). Primary completion is estimated for Feb 2027, 6 months after the start.

Of 164 non-industry interventional studies with no phase under Shock, Septic, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 41. This study's planned 6 months is below that.

Counting every sponsor, half of 172 studies reached it within 25 months; a quarter within 12 and three quarters within 42.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 2, 2026
First posted
Jul 15, 2026
StartActual
Aug 1, 2026
Primary completionEst.
Feb 28, 2027
CompletionEst.
Mar 31, 2027
Last update
Oct 7, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Minor edits
Nothing that changes what the study is or who can join. Edited: date precision
1 update, last Oct 7, 2026
Show all 1 update
  1. Oct 7, 2026
    Minor edits only
    + 1 other change: date precision

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07706413
Lead sponsor
Menoufia University
Responsible party
Hani Hamed Saad (Lecturer of pediatrics at Faculty of medicine , Menoufia university, Menoufia University) — Principal investigator
First posted
Jul 15, 2026
Start date
Aug 1, 2026
Primary completion
Feb 28, 2027 (estimated)
Completion
Mar 31, 2027 (estimated)
Last update
Oct 7, 2026

Study contacts

Hani Hamed Saad, MD, Pediatrics
Contact
hani.hamed870@med.menofia.edu.eg
+201067610619
Nagwan Yossery Saleh, MD, Pediatrics
Contact
drnagwan80@gmail.com
+201003961071
Hani Hamed Saad, MD, pediatrics
principal investigator · Faculty of medicine, Menoufia University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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