ClinicalTrials.gg
RecruitingNCT05044403Updated Jun 10, 2025

Hemoperfusion in Critical Patients With Septic Multiorgan Dysfunction Syndrome.

An interventional study of Extracorporeal support with haemoperfusion and Conventional treatment in Hemoperfusion, Multiorgan Failure and Sepsis, sponsored by Hospital Clinic of Barcelona. Recruiting at 1 site in Spain. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-06-10.

Sponsored by Hospital Clinic of Barcelona · Not applicable, Interventional, and Other

From the registry’s dates

  • Started Mar 2023; still recruiting 3 years 8 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
48
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Hemoperfusion
  • Multiorgan Failure
  • Sepsis
03

In context

Multiple Organ Failure

193 studies on the registry are indexed under Multiple Organ Failure; 47 are open to participants now.

This study's planned enrollment of 48 is below the median of 88 across 90 interventional studies indexed under Multiple Organ Failure.

Browse Multiple Organ Failure studies →

Lead sponsor

Hospital Clinic of Barcelona is the lead sponsor of 327 studies on the registry; 55 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

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 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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
48 participants (estimated)

Study arms

  • Active comparator
    Conventional treatment

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

    Procedure: 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

Interventions

  • ProcedureExtracorporeal support with haemoperfusion

    Use of extracorporeal support with haemoperfusion

  • ProcedureConventional treatment

    Conventional treatment

06

What researchers measure

Primary outcomes

  1. IL-6 plasmatic concentration

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

    Time frame: During hemoperfusion

  2. Adverse events

    Analyze the presence of adverse events during the hemoperfusion process

    Time frame: During hemoperfusion

  3. Organ failure

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

    Time frame: During hemoperfusion

  4. Vasopressors dose

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

    Time frame: During hemoperfusion

  5. Mean arterial pressure

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

    Time frame: During hemoperfusion

  6. Vasopressors dose

    Analyze the number of days on vasopressor support during ICU stay

    Time frame: During ICU stay

  7. Mechanical ventilation

    Analyze the number of days on mechanical ventilation during ICU stay

    Time frame: During ICU stay

  8. Renal replacement therapy

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

    Time frame: During ICU stay

  9. ICU length of stay

    Analyze the patient's length of stay in ICU

    Time frame: Post-Intensive Care Unit discharge

  10. ICU survival

    Analyze the patient's survival in ICU

    Time frame: Post-Intensive Care Unit discharge

  11. Hospital stay

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

    Time frame: post-hospital discharge

  12. Hospital survival

    Analyze the patient's survival post-hospital discharge

    Time frame: Post-hospital discharge

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Yes — Background Abdominal sepsis remains a major challenge in critical care, often associated with high morbidity and mortality. Hemoadsorption therapy has been proposed as a strategy to modulate the systemic inflammatory response in septic patients. However, clinical evidence in the abdominal sepsis population is limited. Conclusions Haemoadsorption appears to be a feasible and safe intervention in patients with abdominal sepsis. Preliminary results suggest potential benefits in inflammatory modulation, organ function improvement, and mortality reduction. Larger, more robust clinical trials are required to confirm efficacy and clarify its impact on clinical outcomes. A more comprehensive and detailed analysis of the results will be provided upon completion of the study.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Mar 2023 to primary completion in Mar 2024, 12 months.

Of 28 interventional studies with no phase under Multiple Organ Failure, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 54. This study's 12 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 3, 2021
First posted
Sep 14, 2021
StartActual
Mar 1, 2023
Primary completionActual
Mar 1, 2024
CompletionEst.
Dec 20, 2025
Last update
Jun 10, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 10, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05044403
Collaborators
Hospital General Universitario de Castellón, Hospital Universitario La Paz, Hospital de Granollers, Hospital General Universitario Santa Lucía
Responsible party
Sponsor
First posted
Sep 14, 2021
Start date
Mar 1, 2023
Primary completion
Mar 1, 2024
Completion
Dec 20, 2025 (estimated)
Last update
Jun 10, 2025

Study contacts

Fernando Sánchez Morán
Contact
sanchez_fermor@gva.es
964399914
Fernando Sanchez Moran
principal investigator · Hospital General Universitario de Castellon

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion