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

Sepsis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05044403
• Other study ID #: MUL-HEMO
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: October 1, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: August 2021
• Source: Hospital Clinic of Barcelona
• Contact: Fernando Sánchez Morán
• Phone: 964399914
• Email: fsanchez201x[@]cv.gva.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: December 31, 2022
• Est. primary completion date: October 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hemoperfusion
• Multiorgan Failure
• Multiple Organ Failure
• Sepsis

Intervention

Procedure:
• Extracorporeal support with haemoperfusion
Use of extracorporeal support with haemoperfusion
• Conventional treatment
Conventional treatment

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Clinic of Barcelona

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vasopressors dose	Analyze the patient's vasopressor dose during the hemoperfusion process	During hemoperfusion
Primary	Vasopressors dose - Intensive Care Unit discharge	Analyze the patient's vasopressor dose prior Intensive Care Unit discharge	Prior Intensive Care Unit discharge
Primary	Vasopressors dose - Hospital discharge	Analyze the patient's vasopressor dose prior Hospital discharge	Prior Hospital discharge
Primary	Vasopressors dose - 90 days post-Intensive Care Unit discharge	Analyze the patient's vasopressor dose 90 days post-Intensive Care Unit discharge	90 days post-Intensive Care Unit discharge