Hemoperfusion in Critical Patients With Septic Multiorgan Dysfunction Syndrome.

Clinical Impact of Hemoperfusion With a Neutral Macroporous Resin Cartridge as Adjunctive Treatment in Septic Patients With Multiorgan Dysfunction Syndrome (MODS) Admitted to Intensive Care Units.

Status

Recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05044403

Enrollment

Registered

2021-09-14

Start date

2023-03-01

Completion date

2025-12-20

Last updated

2025-06-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemoperfusion, Multiorgan Failure, Sepsis

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.

Interventions

PROCEDUREExtracorporeal support with haemoperfusion

Use of extracorporeal support with haemoperfusion

PROCEDUREConventional treatment

Conventional treatment

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
IL-6 plasmatic concentration	During hemoperfusion	Analyze the patient's variation of IL-6 plasmatic concentration during the hemoperfusion process
Adverse events	During hemoperfusion	Analyze the presence of adverse events during the hemoperfusion process
Organ failure	During hemoperfusion	Analyze the number and severity of failed organs during the hemoperfusion process
Vasopressors dose	During hemoperfusion	Analyze the patient's vasopressor dose variation during the hemoperfusion process
Mean arterial pressure	During hemoperfusion	Analyze the patient's variation of mean arterial pressure during hemoperfusion
Mechanical ventilation	During ICU stay	Analyze the number of days on mechanical ventilation during ICU stay
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

Countries

Spain

Contacts

Primary ContactFernando Sánchez Morán

sanchez_fermor@gva.es964399914

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026