Hemoperfusion in Critical Patients With Septic Multiorgan Dysfunction Syndrome.

June 4, 2025 updated by: Hospital Clinic of Barcelona

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.

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
48

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Spain
    • Castellón
      • Castelló de la Plana, Castellón, Spain, 12004
        • Recruiting
        • Hospital General Universitario de Castellon
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Conventional treatment
Patients receiving conventional treatment for multiorganic dysfunction syndrome from septic origin.
Procedure: Conventional treatment
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
Use of extracorporeal support with haemoperfusion

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
IL-6 plasmatic concentration
Time Frame: During hemoperfusion
Analyze the patient's variation of IL-6 plasmatic concentration during the hemoperfusion process
During hemoperfusion
Adverse events
Time Frame: During hemoperfusion
Analyze the presence of adverse events during the hemoperfusion process
During hemoperfusion
Organ failure
Time Frame: During hemoperfusion
Analyze the number and severity of failed organs during the hemoperfusion process
During hemoperfusion
Vasopressors dose
Time Frame: During hemoperfusion
Analyze the patient's vasopressor dose variation during the hemoperfusion process
During hemoperfusion
Mean arterial pressure
Time Frame: During hemoperfusion
Analyze the patient's variation of mean arterial pressure during hemoperfusion
During hemoperfusion
Vasopressors dose
Time Frame: During ICU stay
Analyze the number of days on vasopressor support during ICU stay
During ICU stay
Mechanical ventilation
Time Frame: During ICU stay
Analyze the number of days on mechanical ventilation during ICU stay
During ICU stay
Renal replacement therapy
Time Frame: During ICU stay
Analyze the number of days on renal replacement therapy during ICU stay
During ICU stay
ICU length of stay
Time Frame: Post-Intensive Care Unit discharge
Analyze the patient's length of stay in ICU
Post-Intensive Care Unit discharge
ICU survival
Time Frame: Post-Intensive Care Unit discharge
Analyze the patient's survival in ICU
Post-Intensive Care Unit discharge
Hospital stay
Time Frame: post-hospital discharge
Analyze the patient's length of stay post-Intensive Care Unit discharge
post-hospital discharge
Hospital survival
Time Frame: Post-hospital discharge
Analyze the patient's survival post-hospital discharge
Post-hospital discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hospital Clinic of Barcelona

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Hospital General Universitario Santa Lucia
Hospital Universitario La Paz
Hospital de Granollers
Hospital General Universitario de Castellón

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Fernando Sanchez Moran, Hospital General Universitario de Castellon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 20, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 3, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 6, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 14, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 10, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 4, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MUL-HEMO-2021-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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