Ignite Creation Date:
2024-05-06 @ 7:37 PM
Last Modification Date:
2024-10-26 @ 3:10 PM
Study NCT ID:
NCT06079021
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-08
First Post:
2023-07-26
Brief Title:
COOLEY- Study aCute On chrOnic Liver failurE Using the cYtosorb Device
Sponsor:
University Hospital Antwerp
Organization:
University Hospital Antwerp
Study Overview
Official Title:
COOLEY- Study aCute On chrOnic Liver failurE Using the cYtosorb Device
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COOLEY
Brief Summary:
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
Detailed Description:
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None