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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Application of CytoSorb treatment for 72 hours in patients with ACLF
UZA
Edegem, Antwerp, Belgium
RECRUITINGThe impact of CytoSorb on serum bilirubin removal
20 participants with a serum bilirubin of ≥ 10 mg/dl will undergo CytoSorb for 72 hours
Time frame: 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)
Time frame: 24 and 72 hours
changes in hemodynamic profile
Change in hemodynamic profile (i.e. mean arterial pressure normalized to norepinephrine equivalents) during the 72-h study intervention.
Time frame: 24 and 72 hours
Vasopressors
Duration of vasopressor support in days
Time frame: 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
Time frame: 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.
Time frame: 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
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Time frame: 15 days
Ventilation
Duration of mechanical ventilation,
Time frame: 0, 24 and 72 hours
Cytokines
Changes in cytokines (IL-6, IL-8, IL-16, TNF (tumor necrosis factor)-alpha) value (pg/ml)
Time frame: 0, 24 and 72 hours
Mortality
Mortality at 28, 60 and 90 days after enrolment
Time frame: 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
Time frame: 7, 14, 21 and 90 days after enrolment
Cytosorb filter
Adverse events attributable to CytoSorb up to 28 days after enrolment
Time frame: up to 28 days after enrolment
Change in Bile acids
Bile acids after 72 hours
Time frame: 72 hours after enrolment
Sarcopenia
Prevalence and development of sarcopenia
Time frame: 0, 24 and 72 hours
Anticoagulation
Adverse events attributable to anticoagulation
Time frame: 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
Time frame: Day 0, Day 3, Day 7
Change in inflammatory values: lactate
measurement of lactate (reference \< 2 mmol/L)
Time frame: Day 0, Day 1 and Day 3
Change in inflammatory values: procalcitonin
measurement of procalcitonin (reference \< 0.5 ng/mL)
Time frame: Day 0, Day 1 and Day 3