Hemoperfusion in Critical Patients With Septic Multiorgan Dysfunction Syndrome.

Not Applicable

Recruiting

• Conditions: Hemoperfusion; Multiorgan Failure; Sepsis

• 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 septic multiorgan dysfunction syndrome.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-08-03
• Study First Submitted QC: 2021-09-06
• Study First Posted: 2021-09-14
• Study Start: 2023-03-01
• Primary Completion: 2024-03-01
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-04
• Last Update Posted: 2025-06-10
• Study Completion: 2025-12-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 48

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

Primary Outcome Measures

Name	Time	Method
IL-6 plasmatic concentration	During hemoperfusion	Analyze the patient's variation of IL-6 plasmatic concentration during the hemoperfusion process
Vasopressors dose	During ICU stay	Analyze the number of days on vasopressor support during ICU stay
Mean arterial pressure	During hemoperfusion	Analyze the patient's variation of mean arterial pressure during hemoperfusion
Renal replacement therapy	During ICU stay	Analyze the number of days on renal replacement therapy during ICU stay
ICU length of stay	Post-Intensive Care Unit discharge	Analyze the patient's length of stay in ICU
ICU survival	Post-Intensive Care Unit discharge	Analyze the patient's survival in ICU
Hospital stay	post-hospital discharge	Analyze the patient's length of stay post-Intensive Care Unit discharge
Hospital survival	Post-hospital discharge	Analyze the patient's survival post-hospital discharge
Adverse events	During hemoperfusion	Analyze the presence of adverse events during the hemoperfusion process
Mechanical ventilation	During ICU stay	Analyze the number of days on mechanical ventilation during ICU stay
Organ failure	During hemoperfusion	Analyze the number and severity of failed organs during the hemoperfusion process

Trial Locations

Locations (1)

Hospital General Universitario de Castellon; 🇪🇸 Castelló de la Plana, Castellón, Spain