Sarcopenia Clinical Trial
— COOLEYOfficial title:
COOLEY- Study: aCute On chrOnic Liver failurE Using the cYtosorb Device
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.
Status | Not yet recruiting |
Enrollment | 20 |
Est. completion date | June 30, 2027 |
Est. primary completion date | June 30, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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: - Acute decompensation event (identifiable trigger) - Hepatic encephalopathy grade = 2 - 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) - Serum bilirubin = 10 mg/dl - Hemodynamic instability with vasopressor support (norepinephrine > 0.05 mcg/kg/min) Exclusion Criteria: - • known patient will against participation in the study or against the measures applied in the study - a decision made prior to inclusion to stop further treatment of the patient within the next 24 hours - no complete remission of malignancy including hepatocellular carcinoma within the past 12 months - ongoing intermittent or CRRT before study inclusion |
Country | Name | City | State |
---|---|---|---|
Belgium | UZA | Edegem | Antwerp |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Antwerp | CytoSorbents Europe GmbH |
Belgium,
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. — View Citation
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 Tr — View Citation
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 M — View Citation
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. — View Citation
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 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Secondary | 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 | |
Secondary | Vasopressors | Duration of vasopressor support in days | 24 and 72 hours | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Ventilation | Duration of mechanical ventilation, | 0, 24 and 72 hours | |
Secondary | Cytokines | Changes in cytokines (IL-6, IL-8, IL-16, TNF (tumor necrosis factor)-alpha) value (pg/ml) | 0, 24 and 72 hours | |
Secondary | Mortality | Mortality at 28, 60 and 90 days after enrolment | 28, 60 and 90 days after enrolment | |
Secondary | 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 | |
Secondary | Cytosorb filter | Adverse events attributable to CytoSorb up to 28 days after enrolment | up to 28 days after enrolment | |
Secondary | Change in Bile acids | Bile acids after 72 hours | 72 hours after enrolment | |
Secondary | Sarcopenia | Prevalence and development of sarcopenia | 0, 24 and 72 hours | |
Secondary | Anticoagulation | Adverse events attributable to anticoagulation | 0, 24 and 72 hours | |
Secondary | 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 | |
Secondary | Change in inflammatory values: lactate | measurement of lactate (reference < 2 mmol/L) | Day 0, Day 1 and Day 3 | |
Secondary | Change in inflammatory values: procalcitonin | measurement of procalcitonin (reference < 0.5 ng/mL) | Day 0, Day 1 and Day 3 |
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