Hemoperfusion in Critical Patients With Septic Multiorgan Dysfunction Syndrome.
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorHospital Clinic of Barcelona
About this trial
Low-level interventional clinical trial to evaluate the effectiveness and safety of extracorporeal support with hemoperfusion in critical patients with septic multiorgan dysfunction syndrome.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Sepsis of abdominal origin with controlled infectious focus.
Noradrenaline dose> 0.5 µg / kg / min to maintain adequate organ perfusion after optimization of fluid therapy.
Dysfunction of two or more organs with SOFA ≥ 9 (5).
Blood lactate ≥ 2 mmol / L.
Disqualifiers
Age under 18 years or over 80 years.
Pregnancy or breastfeeding.
Terminally ill patients or with a life expectancy of less than 48 hours.
Thrombocytopenia <60,000 / mm3.
Trial design
Design model
Parallel
Treatments tested in this trial
Extracorporeal support with haemoperfusion
Procedure/SurgeryUse of extracorporeal support with haemoperfusion
Conventional treatment
Procedure/SurgeryConventional treatment
Treatment groups
48 Participants
are divided into 2 treatment groupsGroup A: Conventional treatmentActive comparator 1 intervention
Group B: Extracorporeal support with haemoperfusion treatmentExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
IL-6 plasmatic concentration
Analyze the patient's variation of IL-6 plasmatic concentration during the hemoperfusion process
Time frame
During hemoperfusion2
Adverse events
Analyze the presence of adverse events during the hemoperfusion process
Time frame
During hemoperfusion3
Organ failure
Analyze the number and severity of failed organs during the hemoperfusion process
Time frame
During hemoperfusion4
Vasopressors dose
Analyze the patient's vasopressor dose variation during the hemoperfusion process
Time frame
During hemoperfusionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Hospital Clinic of Barcelona
Lead sponsor
Hospital General Universitario de Castellón
Collaborator
Hospital Universitario La Paz
Collaborator
Hospital de Granollers
Collaborator
Hospital General Universitario Santa Lucía
Collaborator
Source ClinicalTrials.gov