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
調査の概要
詳細な説明
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).
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Hani Hamed Saad, MD, pediatrics
- 電話番号：+201067610619
- メール：hani.hamed870@med.menofia.edu.eg
研究連絡先のバックアップ
- 名前：Nagwan Yossery Saleh, MD, pediatrics
- 電話番号：+201003961071
- メール：drnagwan80@gmail.com
研究場所
-
-
Menoufia Governorate
-
Shibīn al Kawm、Menoufia Governorate、エジプト
- 募集
- Menoufia university hospital, Pediatric intensive care unit
-
コンタクト：
- Hani Hamed Saad, MD, pediatrics
- 電話番号：+201067610619
- メール：hani.hamed870@med.menofia.edu.eg
-
コンタクト：
- Nagwan Yossery Saleh, MD, pediatrics
- 電話番号：+201003961071
- メール：drnagwan80@gmail.com
-
主任研究者：
- Hani Hamed Saad, MD, pediatrics
-
副調査官：
- Nagwan Yossery Saleh, MD, pediatrics
-
副調査官：
- Amira Zaki Badawy, MD, clinical pathology
-
-
参加基準
適格基準
就学可能な年齢
- 子
- 大人
健康ボランティアの受け入れ
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ：Intervention Group (plasma exchange Arm)
this arm will receive standard sepsis management plus therapeutic plasma exchange.
|
Therapeutic plasma exchange to the intervention Group (plasma exchange Arm) that will receive also the standard sepsis management.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Primary Outcome Measure
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in pediatric Sequential Organ Failure Assessment (pSOFA) score
時間枠：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
時間枠：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
時間枠：Up to 28 days
|
Number of days participants remain admitted to the PICU.
|
Up to 28 days
|
|
Time to shock resolution
時間枠：Up to 28 days
|
Time from randomization until resolution of septic shock
|
Up to 28 days
|
|
Change in C-reactive protein (CRP)
時間枠：Baseline, Day 3, and Day 7
|
Change in serum CRP concentration from baseline.
|
Baseline, Day 3, and Day 7
|
|
Change in procalcitonin concentration
時間枠：Baseline, Day 3, and Day 7
|
Change in serum procalcitonin concentration from baseline.
|
Baseline, Day 3, and Day 7
|
|
Platelet count
時間枠：Baseline, Day 3, and Day 7
|
Change in platelet count from baseline.
|
Baseline, Day 3, and Day 7
|
|
International normalized ratio (INR)
時間枠：Baseline, Day 3, and Day 7
|
Change in INR from baseline.
|
Baseline, Day 3, and Day 7
|
|
Fibrinogen concentration
時間枠：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
時間枠：Up to 28 days
|
Number of participants experiencing adverse events related to therapeutic plasma exchange.
|
Up to 28 days
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Hani Hamed Saad, MD, pediatrics、Faculty of medicine, Menoufia University
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 3/2026 PEDI 3
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
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