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

Sponsor

Hospital Clinic of Barcelona (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05044403

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hemoperfusion Multiorgan Failure Sepsis	Procedure: Extracorporeal support with haemoperfusion Procedure: Conventional treatment	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Anticipated Study Start Date :

Oct 1, 2021

Anticipated Primary Completion Date :

Oct 31, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Conventional treatment Patients receiving conventional treatment for multiorganic dysfunction syndrome from septic origin.	Procedure: Conventional treatment Conventional treatment
Experimental: Extracorporeal support with haemoperfusion treatment Patients receiving extracorporeal support with haemoperfusion for multiorganic dysfunction syndrome from septic origin.	Procedure: Extracorporeal support with haemoperfusion Use of extracorporeal support with haemoperfusion

Arm

Intervention/Treatment

Active Comparator: Conventional treatment

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

Procedure: Conventional treatment

Conventional treatment

Experimental: Extracorporeal support with haemoperfusion treatment

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

Procedure: Extracorporeal support with haemoperfusion

Use of extracorporeal support with haemoperfusion

Outcome Measures

Primary Outcome Measures

Vasopressors dose [During hemoperfusion]
Analyze the patient's vasopressor dose during the hemoperfusion process
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
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Hospital Clinic of Barcelona

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hospital Clinic of Barcelona

ClinicalTrials.gov Identifier:

NCT05044403

Other Study ID Numbers:

MUL-HEMO

First Posted:

Sep 14, 2021

Last Update Posted:

Sep 14, 2021

Last Verified:

Aug 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Multiple Organ Failure

Study Results

No Results Posted as of Sep 14, 2021