UZA
Edegem, Antwerp, 2650, Belgium
Location status: Recruiting
Location contact
Karolien Dams, MD
CONTACT
Rita Jacobs, MD
CONTACT
NCT Number: NCT06079021
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Edegem, Antwerp, 2650, Belgium
Location status: Recruiting
Karolien Dams, MD
CONTACT
Rita Jacobs, MD
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Application of CytoSorb treatment for 72 hours in patients with ACLF
Time frame: 24 and 72 hours
20 participants with a serum bilirubin of ≥ 10 mg/dl will undergo CytoSorb for 72 hours
Time frame: 24 and 72 hours
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
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
Duration of vasopressor support in days
Time frame: first week
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: 0, 72 and 168 hours
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: 15 days
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
Time frame: 0, 24 and 72 hours
Duration of mechanical ventilation,
Time frame: 0, 24 and 72 hours
Changes in cytokines (IL-6, IL-8, IL-16, TNF (tumor necrosis factor)-alpha) value (pg/ml)
Time frame: 28, 60 and 90 days after enrolment
Mortality at 28, 60 and 90 days after enrolment
Time frame: 7, 14, 21 and 90 days after enrolment
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: up to 28 days after enrolment
Adverse events attributable to CytoSorb up to 28 days after enrolment
Time frame: 72 hours after enrolment
Bile acids after 72 hours
Time frame: 0, 24 and 72 hours
Prevalence and development of sarcopenia
Time frame: 0, 24 and 72 hours
Adverse events attributable to anticoagulation
Time frame: Day 0, Day 3, Day 7
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 1 and Day 3
measurement of lactate (reference < 2 mmol/L)
Time frame: Day 0, Day 1 and Day 3
measurement of procalcitonin (reference < 0.5 ng/mL)
Contact information is provided by the study sponsor or research team.
Karolien Dams
CONTACT
Rita Jacobs
CONTACT
University Hospital, Antwerp
Other
Acronym: COOLEY
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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