Plasma Exchange Half-dose and Extracorporeal Detoxification for ACLF
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUnidade Local de Saude do Nordeste
About this trial
Clinical trial
The goal of this clinical trial is to learn if a liver support protocol works to treat Liver failure in adults. The main questions it aims to answer are:
* Does hemoadsorption plus half-dose plasma exchange provide support to liver failure patients until recovery or transplant * What medical problems do participants have during the technique? Researchers will compare DPMAS plus half-dose plasma exchange with conventional treatment to evaluate a gain in recovery
Participants will:
* Be submitted to DPMAS plus half dose plasma exchange daily according to protocol. * Monitoring will be continuous in the ICU
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Written informed consent for participation in the study
Admission to the ICU with a diagnosis of ACLF of reversible etiology (infection, bleeding, alcohol-related, toxic, etc.)
Total bilirubin ≥ 12 mg/dL and INR ≥ 1.5
On the waiting list for liver transplantation or not a candidate for transplantation but with an indication for supportive therapy
Disqualifiers
Refusal to provide consent
Pregnancy
Expected survival < 24 hours due to disease severity (hemodynamic instability requiring norepinephrine > 0.20 mcg/kg/min and/or mechanical ventilation with PaO₂/FiO₂ < 150 and/or non-hepatic coma)
ACLF severity greater than CLIF-C ACLF grade 3
Trial design
Design model
Parallel
Treatments tested in this trial
DPMAS plus plasma exchange
DeviceUse of extracorporal technique to support patients with acute on chronic liver failure
Treatment groups
240 Participants
are divided into 2 treatment groupsGroup A: Conventional therapyNo intervention 0 interventions
Group B: DPMAS plus Plasma exchangeExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Mortality or need for liver transplantation
28-day mortality and/or need for liver transplantation
Time frame
From enrollment to 28 days afterSecondary outcomes
1
Total bilirrubin level
Units: mg/dL
Time frame
Daily from date of randomization until ICU discharge or liver trasnplant up to 12 weeks2
INR
International Normalized Ratio
Time frame
Daily from date of randomization until ICU discharge or liver trasnplant up to 12 weeks3
SOFA
Sequential Organ Failure Assessment Score. Scale: 0-24. Higher score means worst outcome.
Time frame
Daily from date of randomization until ICU discharge or liver trasnplant up to 12 weeks.4
CLIF-C ACLF score
Chronic Liver Failure Consortium Acute-on-Chronic Liver Failure score. Range 0-100
Time frame
Measur at day of randomization, 72h after and 7 days afterSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: