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NCT Number: NCT05044403

Hemoperfusion in Critical Patients With Septic Multiorgan Dysfunction Syndrome.

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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Key information

Conditions

Hemoperfusion Infections Inflammation Multiorgan Failure Multiple Organ Failure Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Shock Systemic Inflammatory Response Syndrome

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital General Universitario de Castellon

Castellon, Castellón, 12004, Spain

Location status: Recruiting

Location contact

Fernando Sanchez Moran

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Extracorporeal support with haemoperfusion

Procedure

Use of extracorporeal support with haemoperfusion

Conventional treatment

Procedure

Conventional treatment

Primary outcomes

  1. IL-6 plasmatic concentration

    Time frame: During hemoperfusion

    Analyze the patient's variation of IL-6 plasmatic concentration during the hemoperfusion process

  2. Adverse events

    Time frame: During hemoperfusion

    Analyze the presence of adverse events during the hemoperfusion process

  3. Organ failure

    Time frame: During hemoperfusion

    Analyze the number and severity of failed organs during the hemoperfusion process

  4. Vasopressors dose

    Time frame: During hemoperfusion

    Analyze the patient's vasopressor dose variation during the hemoperfusion process

  5. Mean arterial pressure

    Time frame: During hemoperfusion

    Analyze the patient's variation of mean arterial pressure during hemoperfusion

  6. Vasopressors dose

    Time frame: During ICU stay

    Analyze the number of days on vasopressor support during ICU stay

  7. Mechanical ventilation

    Time frame: During ICU stay

    Analyze the number of days on mechanical ventilation during ICU stay

  8. Renal replacement therapy

    Time frame: During ICU stay

    Analyze the number of days on renal replacement therapy during ICU stay

  9. ICU length of stay

    Time frame: Post-Intensive Care Unit discharge

    Analyze the patient's length of stay in ICU

  10. ICU survival

    Time frame: Post-Intensive Care Unit discharge

    Analyze the patient's survival in ICU

  11. Hospital stay

    Time frame: post-hospital discharge

    Analyze the patient's length of stay post-Intensive Care Unit discharge

  12. Hospital survival

    Time frame: Post-hospital discharge

    Analyze the patient's survival post-hospital discharge

Study contacts

Contact information is provided by the study sponsor or research team.

Fernando Sánchez Morán

CONTACT

[email protected]

964399914

Sponsors and collaborators

Lead sponsor

Hospital Clinic of Barcelona

Other

Collaborators

  • Hospital General Universitario Santa Lucía
  • Hospital General Universitario de Castellón
  • Hospital Universitario La Paz
  • Hospital de Granollers

Registry information

Official study title

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.

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Sep 14, 2021
Registry last updated
Jun 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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