Plasma Exchange in Children With Severe Sepsis and Septic Shock
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Plasma exchange (PE).
- Кому может быть актуально
- Состояния в реестре: Severe Sepsis. Базовые параметры: 1 мес. — 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Египет
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Therapeutic Plasma Exchange in Children With Severe Sepsis and Septic Shock: A Randomized Controlled Clinical Trial
Обзор
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
Подробное описание
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).
Вмешательства
- Процедура Plasma exchange (PE)
Therapeutic plasma exchange to the intervention Group (plasma exchange Arm) that will receive also the standard sepsis management.
Первичные конечные точки
- Primary Outcome Measure [Срок оценки: 28 days]
Вторичные конечные точки (10)
- Change in pediatric Sequential Organ Failure Assessment (pSOFA) score [Срок оценки: Baseline, Day 1, Day 3, and Day 7]
- Duration of vasopressor support [Срок оценки: Up to 28 days]
- Length of pediatric intensive care unit (PICU) stay [Срок оценки: Up to 28 days]
- Time to shock resolution [Срок оценки: Up to 28 days]
- Change in C-reactive protein (CRP) [Срок оценки: Baseline, Day 3, and Day 7]
- Change in procalcitonin concentration [Срок оценки: Baseline, Day 3, and Day 7]
- Platelet count [Срок оценки: Baseline, Day 3, and Day 7]
- International normalized ratio (INR) [Срок оценки: Baseline, Day 3, and Day 7]
- Fibrinogen concentration [Срок оценки: Baseline, Day 3, and Day 7]
- Incidence of therapeutic plasma exchange-related adverse events [Срок оценки: Up to 28 days]
Критерии участия
Критерии включения
- From one month to 18 years.
- With an established diagnosis of severe sepsis or septic shock according to international pediatric sepsis definitions.
Критерии исключения
- 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.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Не применимо
- Модель
- Одна группа
- Маскирование
- Открытое
- Основная цель
- Лечение
Центры проведения
Египет · 1 центр
- Menoufia university hospital, Pediatric intensive care unit — Shibīn al Kawm
Идентификаторы
NCT: NCT07706413 · 3/2026 PEDI 3