Effects of Hemoadsorption on Vascular Integrity in Septic Shock (ADSORP-VIP)
2026年7月14日 更新者：Semmelweis University
Effects of Hemoadsorption on Vascular Integrity in Septic Shock (ADSORP-VIP Trial): Protocol of a Prospective, Randomised, Controlled Trial
This study aims to investigate the effects of adjunctive CytoSorb hemoadsorption therapy versus standard medical treatment on endothelial dysfunction in patients with refractory septic shock.
The investigators hypothesize that hemoadsorption mitigates endothelial and glycocalyx injury by removing inflammatory mediators and other injurious circulating molecules, promoting hemodynamic stabilization.
調査の概要
詳細な説明
This is a prospective, randomised, controlled, open-label, monocentric, proof-of-concept trial.
Patients will be randomly assigned in a 1:1 ratio to receive either standard medical therapy alone or standard therapy plus continuous CytoSorb hemoadsorption for 24 hours.
Blood samples will be collected at baseline, 6, 12, 18, and 24 hours, and then daily for 5 days to analyze endothelial markers, microRNAs, and inflammatory parameters.
An adaptive group sequential design allows for an interim unblinded sample size re-estimation after the first 30 evaluable patients.
研究の種類
介入
入学 (推定)
110
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Tamás Tóth, Dr.
- 電話番号：+36305399474
- メール：tomesz9@gmail.com
研究場所
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Budapest、ハンガリー、1082
- Semmelweis University, Department of Anaesthesiology and Intensive Therapy (Intenzív Terápiás Klinika).
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コンタクト：
- Zsolt Molnár, Prof. Dr.
- 電話番号：+36-1-459-1500
- メール：molnar.zsolt1@semmelweis.hu
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
Inclusion Criteria:
- Septic shock as defined by Sepsis-3 criteria.
- Serum lactate levels >2 and <8 mmol/L at screening.
- Fluid unresponsiveness: Objectively confirmed via dynamic tests or fluid challenges following initial resuscitation.
- Vasopressor Dose Threshold: Norepinephrine base equivalent (NEE) dose > 0.5 µg/kg/min.
- Systemic corticosteroid treatment on board for at least 30 minutes.
- Tissue perfusion impairment: Persistently elevated serum lactate AND/OR prolonged capillary refill time (> 3 seconds) despite standard therapy.
- Alternative causes of shock (e.g., obstructive or cardiogenic) must be ruled out using critical care ultrasonography (CCUS).
- Arterial, central venous catheters and an invasive hemodynamic device (PiCCO, Getinge) in place.
- Inclusion within a maximum of 12 hours after the onset of vasopressor need.
- High likelihood of a dysregulated immune response (PCT ≥ 5 ng/mL AND/OR IL-6 ≥ 1000 pg/mL AND/OR Ferritin ≥ 1000 ng/mL).
- Written informed, retrospective or prospective consent.
Exclusion Criteria:
- Patients under 18 years of age and over 80.
- Unlikely to survive for 24 hours (Moribund).
- Pregnancy.
- SOFA-2 score ≥ 16 at ICU admission.
- Source control is uncertain.
- Thrombocytopenia (<20,000/µL).
- Criteria of standard guideline-based medical treatment not exhausted.
- End-stage organ failure (chronic renal failure (estimated glomerular filtration rate (eGFR) <15 mL/min/1.73 m2), chronic liver failure (MELD Score >30, ChildPugh score class C.), chronic heart failure (New York Heart Association class IV.); severe chronic pulmonary disease (chronic obstructive pulmonary disease: GOLD D)).
- Expected need to disconnect CytoSorb therapy for more than 2 hours (e.g., surgery, CT transfer).
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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：ランダム化
- 介入モデル：並列代入
- 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 |
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アクティブコンパレータ：Standard Medical Therapy (Group A)
Patients will receive standard medical therapy (SMT) according to local protocols based on international 'Surviving Sepsis Campaign' guidelines.
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Standard Medical Therapy according to local protocols based on the current international 'Surviving Sepsis Campaign' guidelines.
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実験的：CytoSorb Therapy (Group B)
Patients will receive standard medical therapy plus a fixed 24-hour continuous hemoadsorption treatment utilizing two sequential CytoSorb cartridges (exchanged at the 12-hour mark).
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Target blood flow rate of 1.5 ml/kg/min, implemented either as a standalone extracorporeal treatment or integrated into a CRRT circuit (CVVHDF mode, preferably with regional citrate anticoagulation).
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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 |
|---|---|---|
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Changes in Syndecan-1 serum levels
時間枠：Baseline (T0), 6, 12, 18, and 24 hours, and then daily up to 5 days (including pre- and postadsorbent samples in the CytoSorb group)
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Serum Syndecan-1, a marker of endothelial glycocalyx injury, will be measured in arterial blood samples.
The outcome is the log-scale change from baseline to the T24 post-baseline Syndecan-1 value in ng/mL.
If the T24 value is missing, the value will be considered missing.
Negative values indicate a decrease from baseline.
Syndecan-1 values will be analysed on the natural logarithmic scale due to expected right skew.
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Baseline (T0), 6, 12, 18, and 24 hours, and then daily up to 5 days (including pre- and postadsorbent samples in the CytoSorb group)
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in Sequential Organ Failure Assessment (SOFA)-2 score
時間枠：Baseline (T0), 24 hours, and then daily up to 5 days.
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Sequential Organ Failure Assessment (SOFA)-2 is an organ dysfunction score used in critically ill patients.
SOFA-2 includes 6 organ systems with total score ranging from 0 to 24 (higher scores indicate worse organ dysfunction).
Change from baseline will be calculated at each post-baseline assessment and reported in score points.
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Baseline (T0), 24 hours, and then daily up to 5 days.
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Change from baseline in arterial blood concentrations of endothelial and glycocalyx-specific markers (Glypican-1, Heparan-sulfate, sICAM-1, sVCAM-1, soluble E-selectin, soluble P-selectin)
時間枠：Baseline (T0), 6, 12, 18, and 24 hours, and then daily up to 5 days.
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Arterial blood concentrations of glypican-1, heparan sulfate, soluble intercellular adhesion molecule-1 (sICAM-1), soluble vascular cell adhesion molecule-1 (sVCAM-1), soluble E-selectin (sE-selectin/CD62E), and soluble P-selectin (sP-selectin) will be measured in ng/mL.
For each biomarker, the change from baseline (T0) will be calculated at each post-baseline assessment.
Results will be reported separately for each biomarker; no composite score will be calculated.
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Baseline (T0), 6, 12, 18, and 24 hours, and then daily up to 5 days.
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Change from baseline in arterial blood concentrations of endothelial markers (MCP-1, VEGF)
時間枠：Baseline (T0), 6, 12, 18, and 24 hours, and then daily up to 5 days.
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Arterial blood concentrations of monocyte chemoattractant protein-1/C-C motif chemokine ligand 2 (MCP-1/CCL2) and vascular endothelial growth factor (VEGF) will be measured in pg/mL.
For each biomarker, the change from baseline (T0) will be calculated at each post-baseline assessment.
Results will be reported separately for each biomarker; no composite score will be calculated.
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Baseline (T0), 6, 12, 18, and 24 hours, and then daily up to 5 days.
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Change from baseline in quantification cycle values of selected microRNAs associated with endothelial function, vascular homeostasis, and inflammation (miR-126, miR-92a, miR-155, miR-21, miR-23a)
時間枠：Baseline (T0) and 6, 12, 18, 24, 48, 72, 96, and 120 hours after T0
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Expression of miR-126, miR-92a, miR-155, miR-21, and miR-23a will be measured in arterial blood samples by quantitative reverse-transcription polymerase chain reaction and reported as quantification cycle (Cq) values.
For each microRNA, change from baseline at each post-baseline time point will be calculated as the Cq value at that time point minus the corresponding Cq value at baseline (T0).
Results will be analyzed and reported separately for each microRNA; no composite or aggregated microRNA score will be calculated.
Hemolyzed samples will be excluded from the microRNA analyses.
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Baseline (T0) and 6, 12, 18, 24, 48, 72, 96, and 120 hours after T0
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Change from baseline in arterial lactate levels
時間枠：Baseline (T0) and 6, 12, 18, 24, 48, 72, 96, and 120 hours after T0
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Arterial lactate concentration will be measured in arterial blood samples and reported in mmol/L.
at each post-baseline time point will be calculated as the arterial lactate concentration at that time point minus the arterial lactate concentration at baseline (T0).
Changes at each time point will be reported separately.
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Baseline (T0) and 6, 12, 18, 24, 48, 72, 96, and 120 hours after T0
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Change from baseline in procalcitonin concentration
時間枠：Baseline (T0) and 6, 12, 18, 24, 48, 72, 96, and 120 hours after T0
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Procalcitonin (PCT) concentration will be measured in arterial blood samples and reported in ng/mL.
For each participant, change from baseline at each post-baseline time point will be calculated as the PCT concentration at that time point minus the PCT concentration at baseline (T0).
Changes at each time point will be reported separately.
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Baseline (T0) and 6, 12, 18, 24, 48, 72, 96, and 120 hours after T0
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Change from baseline in C-reactive protein concentration
時間枠：Baseline (T0) and 6, 12, 18, 24, 48, 72, 96, and 120 hours after T0
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C-reactive protein (CRP) concentration will be measured in arterial blood samples and reported in mg/L.
For each participant, change from baseline at each post-baseline time point will be calculated as the CRP concentration at that time point minus the CRP concentration at baseline (T0).
Changes at each time point will be reported separately.
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Baseline (T0) and 6, 12, 18, 24, 48, 72, 96, and 120 hours after T0
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Change from baseline in white blood cell count
時間枠：Baseline (T0) and 6, 12, 18, 24, 48, 72, 96, and 120 hours after T0
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White blood cell count (WBC) will be measured in arterial blood samples and reported in G/L.
For each participant, change from baseline at each post-baseline time point will be calculated as the WBC count at that time point minus the WBC count at baseline (T0).
Changes at each time point will be reported separately.
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Baseline (T0) and 6, 12, 18, 24, 48, 72, 96, and 120 hours after T0
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Change from baseline in ferritin concentration
時間枠：Baseline (T0) and 6, 12, 18, 24, 48, 72, 96, and 120 hours after T0
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Ferritin concentration will be measured in arterial blood samples and reported in ng/mL.
For each participant, change from baseline at each post-baseline time point will be calculated as the ferritin concentration at that time point minus the ferritin concentration at baseline (T0).
Changes at each time point will be reported separately.
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Baseline (T0) and 6, 12, 18, 24, 48, 72, 96, and 120 hours after T0
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Change from baseline in tumor necrosis factor alpha concentration
時間枠：Baseline (T0) and 6, 12, 18, 24, 48, 72, 96, and 120 hours after T0
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Tumor necrosis factor alpha (TNF-α) concentration will be measured in arterial blood samples and reported in pg/mL.
For each participant, change from baseline at each post-baseline time point will be calculated as the TNF-α concentration at that time point minus the TNF-α concentration at baseline (T0).
Changes at each time point will be reported separately.
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Baseline (T0) and 6, 12, 18, 24, 48, 72, 96, and 120 hours after T0
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Change from baseline in interleukin-1 beta concentration
時間枠：Baseline (T0) and 6, 12, 18, 24, 48, 72, 96, and 120 hours after T0
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Interleukin-1 beta (IL-1β) concentration will be measured in arterial blood samples and reported in pg/mL.
For each participant, change from baseline at each post-baseline time point will be calculated as the IL-1β concentration at that time point minus the IL-1β concentration at baseline (T0).
Changes at each time point will be reported separately.
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Baseline (T0) and 6, 12, 18, 24, 48, 72, 96, and 120 hours after T0
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Change from baseline in interleukin-8 concentration
時間枠：Baseline (T0) and 6, 12, 18, 24, 48, 72, 96, and 120 hours after T0
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Interleukin-8 (IL-8) concentration will be measured in arterial blood samples and reported in pg/mL.
For each participant, change from baseline at each post-baseline time point will be calculated as the IL-8 concentration at that time point minus the IL-8 concentration at baseline (T0).
Changes at each time point will be reported separately.
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Baseline (T0) and 6, 12, 18, 24, 48, 72, 96, and 120 hours after T0
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Change from baseline in extravascular Lung Water Index (EVLWI)
時間枠：Baseline (T0) and 6, 12, 18, 24, 48, 72, 96, and 120 hours after T0
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Extravascular Lung Water Index willl be measured using invasive hemodynamic monitoring and reported in ml/kg.
Change from baseline at each post-baseline time point will be calculated as the EVLWI at that time point minus the EVLWI at baseline
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Baseline (T0) and 6, 12, 18, 24, 48, 72, 96, and 120 hours after T0
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Change from baseline in Vasoactive-Inotropic Score (VIS)
時間枠：Baseline (T0) and 6, 12, 18, 24, 48, 72, 96, and 120 hours after T0
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The Vasoactive-Inotropic Score (VIS) quantifies the amount of cardiovascular support a patient receives through vasoactive and inotropic medications.
The VIS is calculated as: VIS = dopamine (µg/kg/min) + dobutamine (µg/kg/min) + 100 × epinephrine (µg/kg/min) + 100 × norepinephrine (µg/kg/min) + 10 × milrinone (µg/kg/min) + 10 × vasopressin (U/kg/min) at each time point.
Higher score indicates worse outcome.
VIS at each post-baseline time point will be calculated as the VIS at that time point minus the VIS at baseline (T0).
Changes at each time point will be reported separately.
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Baseline (T0) and 6, 12, 18, 24, 48, 72, 96, and 120 hours after T0
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Daily fluid balance through Day 28
時間枠：From T0 through Day 28, assessed every 24 hours
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Daily fluid balance will be calculated for each 24-hour period as total fluid intake minus total fluid output.
Negative values indicate that fluid output exceeded fluid intake during the corresponding 24-hour period.
Daily fluid balance will be reported in mL at each assessment day.
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From T0 through Day 28, assessed every 24 hours
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Time to first negative daily fluid balance
時間枠：From T0 through Day 28
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Time to first negative daily fluid balance will be calculated as the time from T0 to the end of the first 24-hour assessment period during which total fluid output exceeds total fluid intake, corresponding to a daily fluid balance of less than zero.
Time will be reported in days.
Participants who do not achieve a negative daily fluid balance by Day 28 will be censored at Day 28.
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From T0 through Day 28
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Cumulative fluid balance through Day 28
時間枠：From T0 through Day 28, assessed every 24 hours
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Cumulative fluid balance will be calculated as the sum of fluid intake minus fluid output from T0 through each assessment time point.
Negative values indicate that cumulative fluid output exceeded cumulative fluid intake since T0.
Cumulative fluid balance will be reported in mL at each assessment day.
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From T0 through Day 28, assessed every 24 hours
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Time to first negative cumulative fluid balance
時間枠：From T0 through Day 28
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Time to first negative cumulative fluid balance will be calculated as the time from T0 to the first assessment at which cumulative fluid output since T0 exceeds cumulative fluid intake since T0, corresponding to a cumulative fluid balance of less than zero.
Time will be reported in days.
Participants who do not achieve a negative cumulative fluid balance by Day 28 will be censored at Day 28.
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From T0 through Day 28
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Vasopressor-free days through Day 28
時間枠：Day 1 through Day 28
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Vasopressor-free days will be calculated as the number of days from Day 1 through Day 28 during which the participant is alive and free from vasopressor treatment.
A day will be counted as vasopressor-free only when no vasopressor is administered during that day.
The possible range is 0 to 28 days, with higher values indicating more days alive without vasopressor support.
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Day 1 through Day 28
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Mechanical ventilation-free days through Day 28
時間枠：Day 1 through Day 28
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Mechanical ventilation-free days will be calculated as the number of days from Day 1 through Day 28 during which the participant is alive and free from mechanical ventilation.
A day will be counted as ventilation-free only when no mechanical ventilation is provided during that day.
The possible range is 0 to 28 days, with higher values indicating more days alive without mechanical ventilatory support.
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Day 1 through Day 28
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Continuous renal replacement therapy-free days through Day 28
時間枠：Day 1 through Day 28
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Continuous renal replacement therapy (CRRT)-free days will be calculated as the number of days from Day 1 through Day 28 during which the participant is alive and free from CRRT.
A day will be counted as CRRT-free only when no CRRT is administered during that day.
The possible range is 0 to 28 days, with higher values indicating more days alive without CRRT.
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Day 1 through Day 28
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Intensive Care Unit length of stay through Day 28
時間枠：From ICU admission through ICU discharge, death in the ICU, or Day 28, whichever occurs first
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Intensive Care Unit (ICU) length of stay will be calculated as the elapsed time in days from ICU admission to ICU discharge or death in the ICU, whichever occurs first.
Participants who remain in the ICU on Day 28 will be censored at Day 28.
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From ICU admission through ICU discharge, death in the ICU, or Day 28, whichever occurs first
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Survival rates (ICU survival, Hospital survival, and 28-day survival)
時間枠：Up to 28 days.
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ICU survival, hospital survival, and 28-day survival will be recorded separately as alive/deceased status at ICU discharge, hospital discharge, and Day 28 after randomization.
Results will be reported as proportions of participants surviving at each time point.
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Up to 28 days.
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Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
時間枠：From baseline up to 28 days.
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Adverse events, serious adverse events, and device deficiencies will be recorded from baseline through Day 28.
Events will be summarized by incidence, event type, severity, relationship to the study device or procedure, outcome, and seriousness.
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From baseline up to 28 days.
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Zsolt Molnár, Prof. Dr.、Department of Anaesthesiology and Intensive Therapy, Semmelweis University, Budapest, Hungary
- 主任研究者：Péter Hegyi, Prof. Dr.、Centre for Translational Medicine, Semmelweis University, Budapest, Hungary
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年9月1日
一次修了 (推定)
2028年9月1日
研究の完了 (推定)
2029年1月1日
試験登録日
最初に提出
2026年6月30日
QC基準を満たした最初の提出物
2026年7月14日
最初の投稿 (実際)
2026年7月17日
学習記録の更新
投稿された最後の更新 (実際)
2026年7月17日
QC基準を満たした最後の更新が送信されました
2026年7月14日
最終確認日
2026年6月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- ADSORP-VIP
- 1158 (その他の識別子：National Registration Number)
- NNGYK/26060-6/2026 (その他の識別子：Hungarian National Centre for Public Health and Pharmacy resolution number)
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。