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| Name | Class |
|---|---|
| CytoSorbents Europe GmbH | INDUSTRY |
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A Prospective, Single-Center trial, in Patients With Acute on Chronic Liver Failure. Study of Standard Medical Care Plus CytoSorb® Compared to Standard Medical Care Alone in a historical group.
The study team wants to investigate the effect of Cytosorb hemoadsorption on the bilirubin level as well as on the ammonia level changes induced by the therapy in patients with Acute on Chronic Liver Failure (ACLF) .
In this group of patients with ACLF grade 2 and 3 the investigators want to determine the prevalence and development of sarcopenia by sequential quadriceps and thenar ultrasound images and by handgrip strength measurement.
The investigators will objectify muscle mass by skeletal muscle ultrasound of quadriceps and thenar muscles in this sickest subgroup of cirrhotic patients. Ultrasound forms a part of the daily clinical routine in ICU. The study team wants to compare both measurements and objectify the evolution to study the reliability and validity of ultrasound to quantify muscles in chronic liver disease and its clinical values. Most of ultrasonographic studies are based on quadriceps exploration, which is more inconvenient and takes more time than exploring the hands because patients need to remove clothes and lie down. The study team also hypothesizes that thenar muscles are less subject to fluid overload than the quadriceps muscles are.
When available, lumbar skeletal muscle indices will be compared by computed tomography or magnetic resonance imaging.
In this group of patients with ACLF, receiving Continuous Renal Replacement Therapy (CRRT) the appropriate choice of anticoagulant remains controversial. The objective of this study is to compare the efficacy and safety of regional citrate anticoagulation (RCA) and Low Molecular Weight Heparin (LMWH) in critically ill ACLF patients requiring CRRT. These two commercially available anticoagulation methods are used in daily practice in the ICU. The first 10 patients will receive anticoagulation with LMWH with monitoring of anti-Xa. The second cohort of patients will receive RCA.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CytoSorb hemoadsorption | Active Comparator | Patients with acute on chronic liver failure will receive CytoSorb treatment for 72 hours. The aim is to remove the molecules that drive systemic inflammation. |
|
| Control group | No Intervention | Historical group that received only standard medical care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CytoSorb | Device | Application of CytoSorb treatment for 72 hours in patients with ACLF |
|
| Measure | Description | Time Frame |
|---|---|---|
| The impact of CytoSorb on serum bilirubin removal | 20 participants with a serum bilirubin of ≥ 10 mg/dl will undergo CytoSorb for 72 hours | 24 and 72 hours |
| Changes in ammonia and severity of hepatic encephalopathy during treatment period | The West Haven criteria are used for grading the severity of hepatic encephalopathy, which include 5 grades ranging from minimal (slightly impaired) to grade IV (comatose) | 24 and 72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| changes in hemodynamic profile | Change in hemodynamic profile (i.e. mean arterial pressure normalized to norepinephrine equivalents) during the 72-h study intervention. | 24 and 72 hours |
| Vasopressors |
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Inclusion Criteria:
adult patients (≥ 18 years) admitted to the University Hospital of Antwerp (UZA), Belgium.
Written informed consent from patient or if not possible due to encephalopathy (> grade 2): legal representative
acute-on-chronic liver failure (ACLF) grade ≥ 2:
Exclusion Criteria:
• known patient will against participation in the study or against the measures applied in the study
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Karolien Dams | Contact | +3238215175 | Karolien.Dams@uza.be | |
| Rita Jacobs | Contact | +3238214795 | rita.jacobs2@uza.be |
| Name | Affiliation | Role |
|---|---|---|
| Karolien Dams | University Hospital, Antwerp | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UZA | Recruiting | Edegem | Antwerp | 2650 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22429562 | Result | Wlodzimirow KA, Eslami S, Abu-Hanna A, Nieuwoudt M, Chamuleau RA. A systematic review on prognostic indicators of acute on chronic liver failure and their predictive value for mortality. Liver Int. 2013 Jan;33(1):40-52. doi: 10.1111/j.1478-3231.2012.02790.x. Epub 2012 Mar 19. | |
| 36983259 | Result | Popescu M, David C, Marcu A, Olita MR, Mihaila M, Tomescu D. Artificial Liver Support with CytoSorb and MARS in Liver Failure: A Retrospective Propensity Matched Analysis. J Clin Med. 2023 Mar 14;12(6):2258. doi: 10.3390/jcm12062258. |
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| ID | Term |
|---|---|
| D065290 | Acute-On-Chronic Liver Failure |
| D055948 | Sarcopenia |
| ID | Term |
|---|---|
| D017114 | Liver Failure, Acute |
| D017093 | Liver Failure |
| D048550 | Hepatic Insufficiency |
| D008107 | Liver Diseases |
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Application of CytoSorb treatment to ACLF patients
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Duration of vasopressor support in days
| 24 and 72 hours |
| ACLF (Acute on Chronic Liver Failure) Grading | Assessment of ACLF grading (minimum 0 - maximum 3; higher score means a worse outcome) during the 72h intervention up to 1 week after diagnosis of ACLF | first week |
| SOFA Score | Changes in Sequential Organ Failure Assessment (SOFA) (minimum 0-maximum 24; higher score means a worse outcome) score during the 72h study period and up to 1 week after. | 0, 72 and 168 hours |
| scores | Changes in CLIF-C (Chronic Liver Failure Consortium)(minimu 0 - maximum 100; higher score means a worse outcome) score during the 72-h intervention, up to 15 days after diagnosis of ACLF | 15 days |
| Ventilation | Duration of mechanical ventilation, | 0, 24 and 72 hours |
| Cytokines | Changes in cytokines (IL-6, IL-8, IL-16, TNF (tumor necrosis factor)-alpha) value (pg/ml) | 0, 24 and 72 hours |
| Mortality | Mortality at 28, 60 and 90 days after enrolment | 28, 60 and 90 days after enrolment |
| Improvement of Renal function after application of CytoSorb | Acute kidney injury (AKI) according to Kidney Disease: Improving Global Outcome (KDIGO) criteria stage 3 (≥ 3-fold increase of serum creatinine OR increase of serum creatinine to ≥ 4 mg/dl OR urine output ≤ 0.3 ml/kg/h for ≥ 24 hours OR anuria for ≥ 12 hours) will receive CytoSorb treatmetn. Serum creatinine will be measured at day 7, 14, 21 and 90 days | 7, 14, 21 and 90 days after enrolment |
| Cytosorb filter | Adverse events attributable to CytoSorb up to 28 days after enrolment | up to 28 days after enrolment |
| Change in Bile acids | Bile acids after 72 hours | 72 hours after enrolment |
| Sarcopenia | Prevalence and development of sarcopenia | 0, 24 and 72 hours |
| Anticoagulation | Adverse events attributable to anticoagulation | 0, 24 and 72 hours |
| SAPS II score | Simplified Acute Physiology Score II (SAPS II) (minimum 0 - maximum 163; higher score means a worse outcome) during the 72-h study intervention and up to 1 week after | Day 0, Day 3, Day 7 |
| Change in inflammatory values: lactate | measurement of lactate (reference < 2 mmol/L) | Day 0, Day 1 and Day 3 |
| Change in inflammatory values: procalcitonin | measurement of procalcitonin (reference < 0.5 ng/mL) | Day 0, Day 1 and Day 3 |
| 31936597 | Result | Buchard B, Boirie Y, Cassagnes L, Lamblin G, Coilly A, Abergel A. Assessment of Malnutrition, Sarcopenia and Frailty in Patients with Cirrhosis: Which Tools Should We Use in Clinical Practice? Nutrients. 2020 Jan 9;12(1):186. doi: 10.3390/nu12010186. |
| 28389120 | Result | Lopes J, Grams ST, da Silva EF, de Medeiros LA, de Brito CMM, Yamaguti WP. Reference equations for handgrip strength: Normative values in young adult and middle-aged subjects. Clin Nutr. 2018 Jun;37(3):914-918. doi: 10.1016/j.clnu.2017.03.018. Epub 2017 Mar 24. |
| 37240843 | Result | Jacobs R, Verbrugghe W, Dams K, Roelant E, Couttenye MM, Devroey D, Jorens P. Regional Citrate Anticoagulation in Continuous Renal Replacement Therapy: Is Metabolic Fear the Enemy of Logic? A Systematic Review and Meta-Analysis of Randomised Controlled Trials. Life (Basel). 2023 May 17;13(5):1198. doi: 10.3390/life13051198. |
| D004066 |
| Digestive System Diseases |
| D009133 | Muscular Atrophy |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |