Hemoperfusion in Critical Patients With Septic Multiorgan Dysfunction Syndrome.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-01

Study Completion Date

2025-12-20

Brief Summary

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

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Detailed Description

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Conditions

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Hemoperfusion Multiorgan Failure Sepsis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Conventional treatment

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

Group Type ACTIVE_COMPARATOR

Conventional treatment

Intervention Type PROCEDURE

Conventional treatment

Extracorporeal support with haemoperfusion treatment

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

Group Type EXPERIMENTAL

Extracorporeal support with haemoperfusion

Intervention Type PROCEDURE

Use of extracorporeal support with haemoperfusion

Interventions

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Extracorporeal support with haemoperfusion

Use of extracorporeal support with haemoperfusion

Intervention Type PROCEDURE

Conventional treatment

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No