Evaluation of the Efficacy and Safety of Extracorporeal Support With Hemoperfusion in Critical Patients With Multiorgan Dysfunction Syndrome by Septic Origin

Phase 4

• Conditions: Hemoperfusion; Multiorgan Failure; Sepsis
• Interventions: Procedure: Extracorporeal support with haemoperfusion; Procedure: Conventional treatment

• Registration Number: NCT05044403
• Lead Sponsor: Hospital Clinic of Barcelona

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-08
• Study First Submitted: 2021-08-03
• Study First Submitted QC: 2021-09-06
• Last Update Submitted: 2021-09-06
• Study First Posted: 2021-09-14
• Last Update Posted: 2021-09-14
• Study Start: 2021-10-01
• Primary Completion: 2022-10-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Extracorporeal support with haemoperfusion treatment	Extracorporeal support with haemoperfusion	Patients receiving extracorporeal support with haemoperfusion for multiorganic dysfunction syndrome from septic origin.
Conventional treatment	Conventional treatment	Patients receiving conventional treatment for multiorganic dysfunction syndrome from septic origin.

Primary Outcome Measures

Name	Time	Method
Vasopressors dose	During hemoperfusion	Analyze the patient's vasopressor dose during the hemoperfusion process
Vasopressors dose - 90 days post-Intensive Care Unit discharge	90 days post-Intensive Care Unit discharge	Analyze the patient's vasopressor dose 90 days post-Intensive Care Unit discharge
Vasopressors dose - Intensive Care Unit discharge	Prior Intensive Care Unit discharge	Analyze the patient's vasopressor dose prior Intensive Care Unit discharge
Vasopressors dose - Hospital discharge	Prior Hospital discharge	Analyze the patient's vasopressor dose prior Hospital discharge