Severe SepsisPE/SepsisNCT07706413
Plasma Exchange in Children With Severe Sepsis and Septic Shock
A study testing Plasma exchange (PE) in people with Severe Sepsis, run by Menoufia University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Severe Sepsis
- What is being tested?
- Plasma exchange (PE)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2026to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- From one month to 18 years.
- With an established diagnosis of severe sepsis or septic shock according to international pediatric sepsis definitions.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Menoufia university hospital, Pediatric intensive care unit
Shibīn al Kawm, Menoufia Governorate
Hani Hamed Saad, MD, pediatrics, +201067610619, hani.hamed870@med.menofia.edu.eg
Nagwan Yossery Saleh, MD, pediatrics, +201003961071, drnagwan80@gmail.com
About this study
Official title: 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
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:
- - Intervention Group (plasma exchange Arm): Standard sepsis management plus therapeutic plasma exchange.
- - Control Group (Standard care Arm): Standard sepsis management alone. Interventions
Standard Care (Both Groups):
- - Early antimicrobial therapy
- - Fluid resuscitation.
- - Vasopressor and inotropic support
- - Mechanical ventilation as indicated
- - 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:
- Demographic data will be collected from each participant, including age, sex, and weight, height, and body mass index.
- 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.
- Laboratory investigations:
- - 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).
- Conditions
- Severe Sepsis
- Being tested
- Plasma exchange (PE)
- Keywords
- Plasma exchange, severe sepsis, septic shock, childern, Randomized controlled trial
- Medical subject headings
- Sepsis, Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plasma exchange (PE)Procedure or surgery
Therapeutic plasma exchange to the intervention Group (plasma exchange Arm) that will receive also the standard sepsis management.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group (plasma exchange Arm) | Active comparator | this arm will receive standard sepsis management plus therapeutic plasma exchange. Receives: Procedure: Plasma exchange (PE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 28 days
Secondary outcomes (10)
Change in pediatric Sequential Organ Failure Assessment (pSOFA) score
Change in pSOFA score from baseline measured on days 1, 3, and 7 after randomization.
Measured: Baseline, Day 1, Day 3, and Day 7
Duration of vasopressor support
Number of days participants require vasopressor support after randomization.
Measured: Up to 28 days
Length of pediatric intensive care unit (PICU) stay
Number of days participants remain admitted to the PICU.
Measured: Up to 28 days
Time to shock resolution
Time from randomization until resolution of septic shock
Measured: Up to 28 days
Change in C-reactive protein (CRP)
Change in serum CRP concentration from baseline.
Measured: Baseline, Day 3, and Day 7
Change in procalcitonin concentration
Change in serum procalcitonin concentration from baseline.
Measured: Baseline, Day 3, and Day 7
Platelet count
Change in platelet count from baseline.
Measured: Baseline, Day 3, and Day 7
International normalized ratio (INR)
Change in INR from baseline.
Measured: Baseline, Day 3, and Day 7
Fibrinogen concentration
Change in plasma fibrinogen concentration from baseline.
Measured: 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.
Measured: Up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2026
- Study start1 Aug 2026
- Primary completion28 Feb 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe SepsisStudies of the same condition, open and under way.
- More trials run by Menoufia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Menoufia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hani Hamed Saad, Menoufia University
- Investigators
- Hani Hamed Saad, MD, pediatrics, Principal investigator, Faculty of medicine, Menoufia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07706413
- Sponsor's protocol ID
- 3/2026 PEDI 3
- Acronym
- PE/Sepsis
- Status last verified
- Jul 2026
- First submitted
- 2 Jul 2026
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Plasma Exchange in Children With Severe Sepsis and Septic Shock: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07706413
- Acronym / sponsor ID
- PE/Sepsis / 3/2026 PEDI 3
- Conditions
- Severe Sepsis
- Keywords
- Plasma exchange, severe sepsis, septic shock, childern, Randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Menoufia UniversityUniversity, hospital or other
- Study start
- 1 Aug 2026 (actual)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 15 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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:
- - Intervention Group (plasma exchange Arm): Standard sepsis management plus therapeutic plasma exchange.
- - Control Group (Standard care Arm): Standard sepsis management alone. Interventions
Standard Care (Both Groups):
- - Early antimicrobial therapy
- - Fluid resuscitation.
- - Vasopressor and inotropic support
- - Mechanical ventilation as indicated
- - 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:
- Demographic data will be collected from each participant, including age, sex, and weight, height, and body mass index.
- 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.
- Laboratory investigations:
- - 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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group (plasma exchange Arm) | Active comparator | Procedure: Plasma exchange (PE)this arm will receive standard sepsis management plus therapeutic plasma exchange. |
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- From one month to 18 years.
- With an established diagnosis of severe sepsis or septic shock according to international pediatric sepsis definitions.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Plasma exchange (PE)Therapeutic plasma exchange to the intervention Group (plasma exchange Arm) that will receive also the standard sepsis management. | Procedure or surgery | Intervention Group (plasma exchange Arm) |
Primary outcome
Primary Outcome Measure
Time frame: 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.
10 secondary outcomes
Change in pediatric Sequential Organ Failure Assessment (pSOFA) score
Time frame: Baseline, Day 1, Day 3, and Day 7
Duration of vasopressor support
Time frame: Up to 28 days
Length of pediatric intensive care unit (PICU) stay
Time frame: Up to 28 days
Time to shock resolution
Time frame: Up to 28 days
Change in C-reactive protein (CRP)
Time frame: Baseline, Day 3, and Day 7
Change in procalcitonin concentration
Time frame: Baseline, Day 3, and Day 7
Platelet count
Time frame: Baseline, Day 3, and Day 7
International normalized ratio (INR)
Time frame: Baseline, Day 3, and Day 7
Fibrinogen concentration
Time frame: Baseline, Day 3, and Day 7
Incidence of therapeutic plasma exchange-related adverse events
Time frame: Up to 28 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- chrome-extension://efaidnbmnnnibpcajpcglclefindmkaj/https://hrcak.srce.hr/file/407695?utm\_source=consensusLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hani Hamed Saad, MD, pediatrics principal investigator
Faculty of medicine, Menoufia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Plasma exchange (PE) in people with Severe Sepsis, run by Menoufia University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hani Hamed Saad, MD, Pediatrics (+201067610619, hani.hamed870@med.menofia.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Outcome Measure (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.