Hamoadsorpion in Patients With Septic Shock: Efficacy and Safety Evaluation (HAdSS)
Hamoadsorpion in Patients With Septic Shock: Efficacy and Safety Evaluation. A Pilot Multicenter Randomized Controlled Trial
The study will include patients aged 18 to 80 years with a verified diagnosis of septic shock according to SEPSIS 3 criteria, diagnosed within 12 hours, and a SOFA score of 9 or more.
The minimum waiting time after diagnosis of septic shock and initiation of basic therapy before inclusion of the patient in the study therapy is 4 hours.
In addition to Standard of Care (SOC), blood purification, including hemoadsorption, will be used.
The choice of procedure will be based on the EAA (Endotoxin Activity Assay) result:
- for an EAA level of 0.6-0.9, selective lipopolysaccharide (LPS) adsorption with duration from 2 to 10 hours;
- for an EAA level less than 0.6, inflammatory mediator adsorption with duration from 6 to 12 hours.
The choice of a specific adsorbers within the LPS and inflammatory mediator sorption group will be based on randomization.
The use of LPS adsorption is planned based on randomization: Toramyxin R-20 or Efferon LPS. The use of inflammatory mediator adsorption is planned based on randomization: Jafron (HA 330) or CytoSorb.
Every patient will receive 2 adsorption procedures. The second procedure will be initiated no later than 24 hours after the initiation of the first procedure.
LPS adsorption will be performed in 38 patients (Efferon LPS in 19 patients and Toramyxin in 19 patients), two procedures per patient.
Inflammatory mediator adsorption will be performed in 38 patients (Jafron HA 330 in 19 patients and CytoSorb in 19 patients), two procedures per patient.
Sample size calculations were performed separately for each treatment cohort. For the endotoxemia cohort (EAA level of 0.6-0.9), this randomized trial is designed to compare Efferron LPS and Toraymyxin with respect to change in SOFA score at 72 hours.
At present, no universally accepted minimal clinically important difference (MCID) has been established for the SOFA score in patients with septic shock. Therefore, the assumed treatment effect was derived from published evidence and expert clinical judgment.
In the EUPHAS trial, polymyxin B hemoperfusion was associated with a mean reduction in SOFA score of approximately 3.4 points at 72 hours, whereas minimal change was observed in the control group. Similarly, the LASSO study demonstrated substantial improvement in organ dysfunction following endotoxin adsorption therapy.
For the inflammatory mediator adsorption cohort (EAA level less than 0.6), this randomized trial is designed to compare CytoSorb and Jafron HA 330 with respect to change in SOFA score at 72 hours.
In the retrospective study Mehta et al., CytoSorb hemoperfusion was associated with a mean reduction in SOFA score of approximately 2.0 points after treatment in survival group. Similarly, the case series Onuk et al. demonstrated substantial improvement in organ dysfunction following inflammatory adsorption therapy with Jafron HA 330 with a mean reduction in SOFA score of approximately 3.5 points at 72 hours.
A between-group difference of 2.5 SOFA points was considered clinically meaningful for both Endotoxin hemoadsorption and inflammatory mediators hemoadsorption because it represents a substantial proportion of the treatment effect observed in previous hemoperfusion studies and corresponds to a clinically relevant difference in the degree of organ dysfunction improvement.
The sample size for both groups (LPS and inflammatory mediator adsorption) was calculated based on the following assumption: the primary endpoint was the change in SOFA score at 72 hours (ΔSOFA); the expected between-group difference - 2.5 points on the SOFA score; standard deviation of ΔSOFA - 2.5 points; equal allocation ratio (1:1); two-sided significance level (α) of 0.05; statistical power of 80%.
Sample size estimation was performed in R using the power.t.test() function. The calculation yielded a required sample size of 16.7 patients per group. Therefore, a minimum of 17 patients per group (34 patients in total) is required to achieve the planned statistical power.
To account for an anticipated 10% dropout rate, the final sample size will be 19 patients per group (38 patients in total for LPS+ 38 patients in total for Inflammatory mediators adsorption. 76 patients in total).
Přehled studie
Postavení
Podmínky
Detailní popis
Study Inclusion Algorithm
- Diagnosis of septic shock.
- SOFA score calculation.
- Definition of inclusion/exclusion criteria.
- Obtaining informed consent.
- Determining EAA. Selecting the procedure modality (LPS adsorption/inflammatory mediator adsorption).
- Database registration. Obtaining randomization data.
- Selecting a specific device based on randomization.
- Initial data collection.
- Initiating the first procedure.
When a patient is enrolled in the study and is ready to begin the hemoadsorption procedure, the following parameters are assessed:
- Dose of norepinephrine (mcg/kg/min).
- Dose of alternative vasopressors: epinephrine (mcg/kg/min), dopamine (mcg/kg/min), phenylephrine (mcg/kg/min), dobutamine (mcg/kg/min), terlipressin (mcg/kg/min). VIS will be calculated.
- Mean arterial pressure (MAP) based on invasive hemodynamic monitoring.
- Fractional oxygen content (%).
- Diuresis rate over 12 hours (ml/kg/hour).
Blood sampling:
Arterial blood acid-base balance:
- Arterial blood lactate level (mmol/L).
- PaO2- Partial pressure of oxygen in arterial blood (mmHg).
Blood chemistry panel:
- Total bilirubin level (μmol/L).
- Direct bilirubin level (μmol/L).
- Indirect bilirubin level (μmol/L).
- Procalcitonin level (ng/ml).
- C-reactive protein (CRP) level (mg/L).
- Creatinine level (μmol/L).
- Ferritin level (μg/L).
Complete blood count White blood cell count
- Absolute neutrophil count (cells/µL).
- Absolute lymphocyte count (cells/µL).
- Absolute platelet count (10.9 /L).
- Blood collection for immunological testing (IL 6, IL 10, TNF).
Upon patient enrollment in the study, a description of the CRRT procedure parameters, dialysis membrane type, anticoagulation type, antibacterial agents, and suspected infectious agents is provided in the electronic patient record.
Data collection will occur at 24, 48, 72, and 120 hours from the start of the first hemoadsorption procedure.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Aleksandr Burov, PHD
- Telefonní číslo: +79854215478
- E-mail: Aleksander.bour@mail.ru
Studijní místa
-
-
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Moscow, Rusko
- Petrovsky National Research Centre of Surgery
-
Kontakt:
- Maxim Babaev, MD, PHD
- Telefonní číslo: +79160269066
- E-mail: maxbabaev@mail.ru
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Moscow, Rusko
- Bakulev Scientific Center of Cardiovascular Surgery
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Kontakt:
- Mikhail Yarustovskiy, MD, PHD
- Telefonní číslo: +79104194682
- E-mail: mbyar@yandex.ru
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Moscow, Rusko
- City clinical hospital named after S. S. Yudin, Moscow City Health
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Kontakt:
- Nikolay Krotenko, PHD
- Telefonní číslo: +79268664976
- E-mail: npkrotenko@gmail.com
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Moscow, Rusko
- City Clinical Hospital No 52, Moscow, Russia
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Kontakt:
- Rustam Iskhakov
- Telefonní číslo: +79265317813
- E-mail: stamius@yandex.ru
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Moscow, Rusko
- Moscow Multi-disciplinary Clinical Center "Kommunarka"
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Moscow, Rusko
- Sklifosovsky Institute of Emergency Care
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Kontakt:
- Sergei Rei, PHD
- Telefonní číslo: +79166001362
- E-mail: reysi@sklif.mos.ru
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Rostov-on-Don, Rusko
- National Medical Research Centre for Oncology Rostov-on-Don
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Kontakt:
- Natalia Ushakova, MD, PHD
- Telefonní číslo: +79185533155
- E-mail: ndu2000@rambler.ru
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- Septic shock according to SEPSIS-3 criteria
- Age: 18-80 years
- SOFA ≥9 points
- Diagnosis of septic shock established <12 hours ago
- Invasive hemodynamic monitoring
- Norepinephrine dose >0.2 mcg/kg/min
Exclusion Criteria:
- Absolute neutrophil count less than 500 cells/μL
- Pregnancy
- End-stage heart failure (NYHA stage IV)
- Pulmonary embolism with obstructive shock
- Ongoing bleeding
- Atonic coma
- More than 30 points on the MELD scale, class C on the Child-Pugh scale
- HIV infection
- Burns over 10% of the body surface area
- Patients with oncohematological diseases
- Patients with a recognized palliative status or the definition of "metastatic cancer"
- RRT using membranes with a high cutoff point and increased adsorption capacity within 72 hours from the initiation of the first hemoadsorption procedure
- Use of plasma exchange within 72 hours from the initiation of the first hemoadsorption procedure
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Dvojnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: Inflammatory mediatiors adsorption with CytoSorb
Inflammatory mediatiors adsorption with EAA <0,6 with CytoSorb
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Blood purification with Jafron HA 330
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Aktivní komparátor: Inflammatory mediatiors adsorption with Jafron HA 330
Inflammatory mediatiors adsorption with EAA <0,6 with Jafron HA 330
|
Blood purification with Jafron HA 330
|
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Experimentální: Endotoxin haemoadsorption with Toramyxin PMX 20R
Endotoxin haemoadsorption with EAA [0.6-0.9] with Toramyxin PMX 20R
|
Blood purification with Toramyxin PMX 20R
|
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Aktivní komparátor: Endotoxin haemoadsorption with Efferon LPS
Endotoxin haemoadsorption with EAA [0.6-0.9] with Efferon LPS
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Blood purification with Efferon LPS
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
SOFA score
Časové okno: Assessed at 72 hours after hemoadsorption initiation
|
MODS dynamics majored by SOFA (sequential organ failure assessment) score
|
Assessed at 72 hours after hemoadsorption initiation
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
VIS dynamics
Časové okno: Assessed at 4 time points: before hemoadsorption initiation (baseline); 24 hours, 48 hours and 72 hours after hemoadsorption initiation
|
Vasoactive Inotropic Score (VIS) dynamics VIS = dopamine dose (mcg∕kg∕ min ) + dobutamine dose (mcg∕kg∕ min ) + 100 × epinephrine dose (mcg∕kg∕ min ) + 10 × milrinone dose (mcg∕kg∕ min ) + 10,000 × vasopressin dose (units∕kg∕ min ) + 100 × norepinephrine dose (mcg∕kg∕ min ) |
Assessed at 4 time points: before hemoadsorption initiation (baseline); 24 hours, 48 hours and 72 hours after hemoadsorption initiation
|
|
NE dose dynamics
Časové okno: Assessed at 4 time points: before hemoadsorption initiation (baseline); 24 hours, 48 hours and 72 hours after hemoadsorption initiation
|
Norepinephrine dose dynamics (mcg/kg/min)
|
Assessed at 4 time points: before hemoadsorption initiation (baseline); 24 hours, 48 hours and 72 hours after hemoadsorption initiation
|
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MAP/VIS dynamics
Časové okno: Assessed at 4 time points: before hemoadsorption initiation (baseline); 24 hours, 48 hours and 72 hours after hemoadsorption initiation
|
Mean arterial pressure (MAP) to Vasoactive Inotropic Score (VIS) dynamics VIS = dopamine dose (mcg∕kg∕ min ) + dobutamine dose (mcg∕kg∕ min ) + 100 × epinephrine dose (mcg∕kg∕ min ) + 10 × milrinone dose (mcg∕kg∕ min ) + 10,000 × vasopressin dose (units∕kg∕ min ) + 100 × norepinephrine dose (mcg∕kg∕ min ) |
Assessed at 4 time points: before hemoadsorption initiation (baseline); 24 hours, 48 hours and 72 hours after hemoadsorption initiation
|
|
P/f ratio dynamics
Časové okno: Assessed at 4 time points: before hemoadsorption initiation (baseline); 24 hours, 48 hours and 72 hours after hemoadsorption initiation
|
Arterial oxygen partial pressure (PaO2)/fraction of inspired oxygen (FiO2) ratio (Horowitz index) dynamics
|
Assessed at 4 time points: before hemoadsorption initiation (baseline); 24 hours, 48 hours and 72 hours after hemoadsorption initiation
|
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Lactate level dynamics
Časové okno: Assessed at 4 time points: before hemoadsorption initiation (baseline); 24 hours, 48 hours and 72 hours after hemoadsorption initiation
|
Lactate level dynamics (mmol/l)
|
Assessed at 4 time points: before hemoadsorption initiation (baseline); 24 hours, 48 hours and 72 hours after hemoadsorption initiation
|
|
Total bilirubin level dynamics
Časové okno: Assessed at 4 time points: before hemoadsorption initiation (baseline); 24 hours, 48 hours and 72 hours after hemoadsorption initiation
|
Total bilirubin level dynamics (mcmol/l)
|
Assessed at 4 time points: before hemoadsorption initiation (baseline); 24 hours, 48 hours and 72 hours after hemoadsorption initiation
|
|
Indirect bilirubin level dynamics
Časové okno: Time Frame: Assessed at 4 time points: before hemoadsorption initiation (baseline); 24 hours, 48 hours and 72 hours after hemoadsorption initiation
|
Indirect bilirubin level dynamics (mcmol/l)
|
Time Frame: Assessed at 4 time points: before hemoadsorption initiation (baseline); 24 hours, 48 hours and 72 hours after hemoadsorption initiation
|
|
Direct bilirubin level dynamics
Časové okno: Time Frame: Assessed at 4 time points: before hemoadsorption initiation (baseline); 24 hours, 48 hours and 72 hours after hemoadsorption initiation
|
Direct bilirubin level dynamics (mcmol/l)
|
Time Frame: Assessed at 4 time points: before hemoadsorption initiation (baseline); 24 hours, 48 hours and 72 hours after hemoadsorption initiation
|
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Ferritin level dynamics
Časové okno: Time Frame: Assessed at 4 time points: before hemoadsorption initiation (baseline); 24 hours, 48 hours and 72 hours after hemoadsorption initiation
|
Ferritin level dynamics (mcg/l)
|
Time Frame: Assessed at 4 time points: before hemoadsorption initiation (baseline); 24 hours, 48 hours and 72 hours after hemoadsorption initiation
|
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PCT level dynamics
Časové okno: Time Frame: Assessed at 4 time points: before hemoadsorption initiation (baseline); 24 hours, 48 hours and 72 hours after hemoadsorption initiation
|
Procalcitonin (PCT) level dynamics (ng/ml)
|
Time Frame: Assessed at 4 time points: before hemoadsorption initiation (baseline); 24 hours, 48 hours and 72 hours after hemoadsorption initiation
|
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CRP level dynamics
Časové okno: Time Frame: Assessed at 4 time points: before hemoadsorption initiation (baseline); 24 hours, 48 hours and 72 hours after hemoadsorption initiation
|
C- reactive protein (CRP) level dynamics (mg/l)
|
Time Frame: Assessed at 4 time points: before hemoadsorption initiation (baseline); 24 hours, 48 hours and 72 hours after hemoadsorption initiation
|
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NLR dynamics
Časové okno: Time Frame: Assessed at 4 time points: before hemoadsorption initiation (baseline); 24 hours, 48 hours and 72 hours after hemoadsorption initiation
|
NLR (neutrophil-to-lymphocyte ratio) dynamics
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Time Frame: Assessed at 4 time points: before hemoadsorption initiation (baseline); 24 hours, 48 hours and 72 hours after hemoadsorption initiation
|
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PLR dynamics
Časové okno: Assessed at 4 time points: before hemoadsorption initiation (baseline); 24 hours, 48 hours and 72 hours after hemoadsorption initiation
|
PLR (Platelet-to-lymphocyte ratio) dynamics
|
Assessed at 4 time points: before hemoadsorption initiation (baseline); 24 hours, 48 hours and 72 hours after hemoadsorption initiation
|
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TNF level dynamics
Časové okno: Assessed at 3 time points: before hemoadsorption initiation (baseline); 48 hours and 72 hours after hemoadsorption initiation
|
TNF (Tumor necrosis factor-alpha) level dynamics (pg/ml)
|
Assessed at 3 time points: before hemoadsorption initiation (baseline); 48 hours and 72 hours after hemoadsorption initiation
|
|
IL 6 level dynamics
Časové okno: Assessed at 3 time points: before hemoadsorption initiation (baseline); 48 hours and 72 hours after hemoadsorption initiation
|
IL 6 (Interleukin 6) level dynamics (pg/ml)
|
Assessed at 3 time points: before hemoadsorption initiation (baseline); 48 hours and 72 hours after hemoadsorption initiation
|
|
IL 10 level dynamics
Časové okno: Time Frame: Assessed at 3 time points: before hemoadsorption initiation (baseline); 48 hours and 72 hours after hemoadsorption initiation
|
IL 10 (Interleukin 10) level dynamics (pg/ml)
|
Time Frame: Assessed at 3 time points: before hemoadsorption initiation (baseline); 48 hours and 72 hours after hemoadsorption initiation
|
|
28 - days mortality
Časové okno: Will be calculated for 28 days after hemoadsorption initiation
|
28 - days mortality
|
Will be calculated for 28 days after hemoadsorption initiation
|
|
90 - days mortality
Časové okno: Will be calculated for 90 days after hemoadsorption initiation
|
90 - days mortality
|
Will be calculated for 90 days after hemoadsorption initiation
|
|
SOFA dynamics
Časové okno: Assessed at 4 time points: before hemoadsorption initiatioin (baseline); at 24, 48 and 120 hours after hemoadsorption initiation
|
MODS dynamics majored by SOFA (sequential organ failure assessment) score
|
Assessed at 4 time points: before hemoadsorption initiatioin (baseline); at 24, 48 and 120 hours after hemoadsorption initiation
|
|
SOFA 2 dynamics
Časové okno: Assessed at 5 time points: before hemoadsorption initiatioin (baseline); at 24, 48, 72 and 120 hours after hemoadsorption initiation
|
MODS dynamics majored by SOFA 2 (sequential organ failure assessment) score
|
Assessed at 5 time points: before hemoadsorption initiatioin (baseline); at 24, 48, 72 and 120 hours after hemoadsorption initiation
|
Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Ventilator-free days
Časové okno: Will be calculated for 28 days after hemoadsorption initiation
|
Ventilator-free days
|
Will be calculated for 28 days after hemoadsorption initiation
|
|
Vasopressor-free days
Časové okno: Will be calculated for 28 days after hemoadsorption initiation
|
Vasopressor-free days
|
Will be calculated for 28 days after hemoadsorption initiation
|
|
Dialysis-free days
Časové okno: Will be calculated for 28 days after hemoadsorption initiation
|
Dialysis-free days
|
Will be calculated for 28 days after hemoadsorption initiation
|
|
Hospital length of stay
Časové okno: Will be calculated for 28 days after hemoadsorption initiation
|
Hospital length of stay
|
Will be calculated for 28 days after hemoadsorption initiation
|
|
ICU length of stay
Časové okno: Will be calculated for 28 days after hemoadsorption initiation
|
Intensive care unit (ICU) length of stay
|
Will be calculated for 28 days after hemoadsorption initiation
|
|
AEs
Časové okno: Serious AEs will be reported up to Day 28
|
The safety will be assessed by analysing the number of adverse events (AEs) where causal relationship with the intervention cannot be excluded, up until Day 28.
|
Serious AEs will be reported up to Day 28
|
Spolupracovníci a vyšetřovatelé
Spolupracovníci
Vyšetřovatelé
- Ředitel studie: Denis Protsenko, MD, PHD, Moscow Multi-disciplinary Clinical Center "Kommunarka"
Publikace a užitečné odkazy
Obecné publikace
- Cruz DN, Antonelli M, Fumagalli R, Foltran F, Brienza N, Donati A, Malcangi V, Petrini F, Volta G, Bobbio Pallavicini FM, Rottoli F, Giunta F, Ronco C. Early use of polymyxin B hemoperfusion in abdominal septic shock: the EUPHAS randomized controlled trial. JAMA. 2009 Jun 17;301(23):2445-52. doi: 10.1001/jama.2009.856.
- Onuk S, Akin AK, Sari A, Gundogan K, Baskol G, Dogru K, Sungur M. The Clinical and Laboratory Efficacy of HA 330 Treatment Combined with Continuous Renal Replacement Therapy in Septic Shock Patients: A Case Series. Blood Purif. 2023;52(2):140-147. doi: 10.1159/000528150. Epub 2023 Jan 12.
- Mehta Y, Mehta C, Kumar A, George JV, Gupta A, Nanda S, Kochhar G, Raizada A. Experience with hemoadsorption (CytoSorb(R)) in the management of septic shock patients. World J Crit Care Med. 2020 Jan 31;9(1):1-12. doi: 10.5492/wjccm.v9.i1.1. eCollection 2020 Jan 31.
- Rey S, Kulabukhov VM, Popov A, Nikitina O, Berdnikov G, Magomedov M, Kim T, Masolitin S, Ignatenko O, Krotenko N, Marysheva A, Chaus N, Ohinko L, Mendibaev M, Chumachenko A, Pisarev V. HEMOPERFUSION USING THE LPS-SELECTIVE MESOPOROUS POLYMERIC ADSORBENT IN SEPTIC SHOCK: A MULTICENTER RANDOMIZED CLINICAL TRIAL. Shock. 2023 Jun 1;59(6):846-854. doi: 10.1097/SHK.0000000000002121. Epub 2023 Apr 6.
- Klein DJ, Foster D, Walker PM, Bagshaw SM, Mekonnen H, Antonelli M. Polymyxin B hemoperfusion in endotoxemic septic shock patients without extreme endotoxemia: a post hoc analysis of the EUPHRATES trial. Intensive Care Med. 2018 Dec;44(12):2205-2212. doi: 10.1007/s00134-018-5463-7. Epub 2018 Nov 23.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- HAdSS
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
Časový rámec sdílení IPD
Kritéria přístupu pro sdílení IPD
Typ podpůrných informací pro sdílení IPD
- PROTOKOL STUDY
- MÍZA
- CSR
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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