RECRUITINGINTERVENTIONAL
Hemoperfusion in Critical Patients With Septic Multiorgan Dysfunction Syndrome.
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.
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.
Who May Be Eligible (Plain English)
Who May Qualify:
- 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.
Who Should NOT Join This Trial:
- 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.
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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.
Treatments Being Tested
PROCEDURE
Extracorporeal support with haemoperfusion
Use of extracorporeal support with haemoperfusion
PROCEDURE
Conventional treatment
Conventional treatment
Locations (1)
Hospital General Universitario de Castellon
Castellon, Castellón, Spain