Clinical trial NCT05044403: Hemoperfusion in Critical Patients With Septic Multiorgan Dysfunction Syndrome.
Official title: Clinical Impact of Hemoperfusion With a Neutral Macroporous Resin Cartridge as Adjunctive Treatment in Septic Patients With Multiorgan Dysfunction Syndrome (MODS) Admitted to Intensive Care Units.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hemoperfusion
Multiorgan Failure
Sepsis
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
Collaborators: name: Hospital General Universitario de Castellón
name: Hospital Universitario La Paz
name: Hospital de Granollers
name: Hospital General Universitario Santa Lucía
First posted: 2021-09-14
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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: Inclusion Criteria:

* Patients with a sepsis diagnosis, according to the diagnostic criteria of the International Sepsis-3 Consensus Conference, and without response to the treatment of septic shock who meet the following conditions:
* 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.
* Procalcitonin (PCT)\> 10 ng / mL.
* CRP\> 100 mg / L.
* IL-6\> 2000 pg / ml.

Exclusion Criteria:

* 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.
* Pancytopenia.
* Severe coagulopathy with high risk of bleeding.
* Inclusion in another research protocol.
* In case of re-entry during the study period, only the first admission will be included.
* Use of another haemoperfusion device.

Primary outcomes:
measure: IL-6 plasmatic concentration
timeFrame: During hemoperfusion
measure: Adverse events
timeFrame: During hemoperfusion
measure: Organ failure
timeFrame: During hemoperfusion
measure: Vasopressors dose
timeFrame: During hemoperfusion
measure: Mean arterial pressure
timeFrame: During hemoperfusion
measure: Vasopressors dose
timeFrame: During ICU stay
measure: Mechanical ventilation
timeFrame: During ICU stay
measure: Renal replacement therapy
timeFrame: During ICU stay
measure: ICU length of stay
timeFrame: Post-Intensive Care Unit discharge
measure: ICU survival
timeFrame: Post-Intensive Care Unit discharge
measure: Hospital stay
timeFrame: post-hospital discharge
measure: Hospital survival
timeFrame: Post-hospital discharge
Secondary outcomes:
Other outcomes:
Locations:
city: Castelló de la Plana
country: Spain
facility: Hospital General Universitario de Castellon
state: Castellón
Study officials:
affiliation: Hospital General Universitario de Castellon
name: Fernando Sanchez Moran
role: PRINCIPAL_INVESTIGATOR
References: