Hemoperfusion in Critical Patients With Septic Multiorgan Dysfunction Syndrome.

Hospital Clinic of Barcelona

Status: Enrolling

Conditions: Multiorgan Failure; Sepsis; Hemoperfusion

Treatments: Procedure: Extracorporeal support with haemoperfusion; Procedure: Conventional treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT05044403

MUL-HEMO-2021-1

Details and patient eligibility

About

Low-level interventional clinical trial to evaluate the effectiveness and safety of extracorporeal support with hemoperfusion in critical patients with septic multiorgan dysfunction syndrome.

Enrollment: 48 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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48 participants in 2 patient groups

Conventional treatment

Active Comparator group

Description:

Patients receiving conventional treatment for multiorganic dysfunction syndrome from septic origin.

Treatment:

Procedure: Conventional treatment

Extracorporeal support with haemoperfusion treatment

Experimental group

Description:

Patients receiving extracorporeal support with haemoperfusion for multiorganic dysfunction syndrome from septic origin.

Treatment:

Procedure: Extracorporeal support with haemoperfusion