RecruitingNot ApplicableNCT05044403
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.
Sponsor
Hospital Clinic of Barcelona
Enrollment
48 participants
Start Date
Mar 1, 2023
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 18 YearsMax Age: 80 Years
Inclusion Criteria8
- 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 Criteria9
- 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.
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Interventions
PROCEDUREExtracorporeal support with haemoperfusion
Use of extracorporeal support with haemoperfusion
PROCEDUREConventional treatment
Conventional treatment
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05044403
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