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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05044403
Other study ID # MUL-HEMO
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received
Last updated
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
Health authority
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.

Study Design


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
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