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
연구 개요
상세 설명
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:
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).
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Hani Hamed Saad, MD, pediatrics
- 전화번호: +201067610619
- 이메일: hani.hamed870@med.menofia.edu.eg
연구 연락처 백업
- 이름: Nagwan Yossery Saleh, MD, pediatrics
- 전화번호: +201003961071
- 이메일: drnagwan80@gmail.com
연구 장소
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Menoufia Governorate
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Shibīn al Kawm, Menoufia Governorate, 이집트
- 모병
- Menoufia university hospital, Pediatric intensive care unit
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연락하다:
- Hani Hamed Saad, MD, pediatrics
- 전화번호: +201067610619
- 이메일: hani.hamed870@med.menofia.edu.eg
-
연락하다:
- Nagwan Yossery Saleh, MD, pediatrics
- 전화번호: +201003961071
- 이메일: drnagwan80@gmail.com
-
수석 연구원:
- Hani Hamed Saad, MD, pediatrics
-
부수사관:
- Nagwan Yossery Saleh, MD, pediatrics
-
부수사관:
- Amira Zaki Badawy, MD, clinical pathology
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- From one month to 18 years.
- With an established diagnosis of severe sepsis or septic shock according to international pediatric sepsis definitions.
Exclusion Criteria:
- 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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
활성 비교기: Intervention Group (plasma exchange Arm)
this arm will receive standard sepsis management plus therapeutic plasma exchange.
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Therapeutic plasma exchange to the intervention Group (plasma exchange Arm) that will receive also the standard sepsis management.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Primary Outcome Measure
기간: 28 days
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All-cause mortality within 28 days after randomization, defined as the proportion of participants who die from any cause within 28 days of enrollment.
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28 days
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in pediatric Sequential Organ Failure Assessment (pSOFA) score
기간: Baseline, Day 1, Day 3, and Day 7
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Change in pSOFA score from baseline measured on days 1, 3, and 7 after randomization.
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Baseline, Day 1, Day 3, and Day 7
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Duration of vasopressor support
기간: Up to 28 days
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Number of days participants require vasopressor support after randomization.
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Up to 28 days
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Length of pediatric intensive care unit (PICU) stay
기간: Up to 28 days
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Number of days participants remain admitted to the PICU.
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Up to 28 days
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Time to shock resolution
기간: Up to 28 days
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Time from randomization until resolution of septic shock
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Up to 28 days
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Change in C-reactive protein (CRP)
기간: Baseline, Day 3, and Day 7
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Change in serum CRP concentration from baseline.
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Baseline, Day 3, and Day 7
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Change in procalcitonin concentration
기간: Baseline, Day 3, and Day 7
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Change in serum procalcitonin concentration from baseline.
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Baseline, Day 3, and Day 7
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Platelet count
기간: Baseline, Day 3, and Day 7
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Change in platelet count from baseline.
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Baseline, Day 3, and Day 7
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International normalized ratio (INR)
기간: Baseline, Day 3, and Day 7
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Change in INR from baseline.
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Baseline, Day 3, and Day 7
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Fibrinogen concentration
기간: Baseline, Day 3, and Day 7
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Change in plasma fibrinogen concentration from baseline.
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Baseline, Day 3, and Day 7
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Incidence of therapeutic plasma exchange-related adverse events
기간: Up to 28 days
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Number of participants experiencing adverse events related to therapeutic plasma exchange.
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Up to 28 days
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공동 작업자 및 조사자
수사관
- 수석 연구원: Hani Hamed Saad, MD, pediatrics, Faculty of medicine, Menoufia University
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 3/2026 PEDI 3
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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