Septic ShockACMEcatNCT06500156
Metabolic Cluster Analysis in Septic Shock Patients
An observational study of Septic Shock, run by Corporacion Parc Tauli at 1 site in Spain.
Trial summary
Observational study including septic shock patients within 24 hours of ICU admission, monitored with a cardiac output estimation system, with ongoing resuscitation. Hemodynamic and metabolic parameters before and after a fluid challenge (FC) will be measured. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Septic Shock
- What is being tested?
- Fluid challenge
- Type of treatment
- Injection or infusion
- How many people
- 120 participants
- Where
- 1 siteSpain
- Study dates
- 1 May 2024to 31 Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Septic shock patients within the first 24 hours of ICU admission, and selected by the attending physician for performing a fluid challenge (FC) due to suspected tissue hypoperfusion.
Who may be able to join
- Septic shock patients within the first 24 hours of ICU admission, and selected by the attending physician for performing a fluid challenge (FC) due to suspected tissue hypoperfusion (elevated lactate and/or ScvO2 < 70%).
Who cannot join
- Age under 18 years old
- Uncontrolled hemodynamic instability, defined as the need for significant changes in vasopressor support (> 10% from baseline dose) within the 15-minute period prior to, and/or during the administration of fluids.
- Patients receiving continuous renal replacement therapies, since the CO values obtained from the thermodilution techniques might be potentially affected.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ferran Oller, MD contact
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitari Parc Taulí
Sabadell, Barcelona, 08208
Jaume Mesquida, MD, +34937231010, jaume.mesquida@gmail.com
Ferran Oller, MD, ferranollersanchez@gmail.com
About this study
Official title: Metabolic Cluster Analysis in Septic Shock Patients Undergoing Hemodynamic Resuscitation. A Multicenter Observational Study
Observational study including septic shock patients within 24 hours of ICU admission, monitored with a cardiac output estimation system, with ongoing resuscitation. Hemodynamic and metabolic parameters before and after a fluid challenge (FC) will be measured.
- Conditions
- Septic Shock
- Being tested
- Fluid challenge
- Keywords
- septic shock, hemodynamic resuscitation, cardiovascular monitoring
- Medical subject headings
- Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluid challengeOther
Rapid infusion (< 15 minutes) of a fluid bolus of crystalloids (200 to 500cc)
| Study group | Role | What they receive |
|---|---|---|
| Septic shock | Septic shock patients within the first 24 hours of ICU admission, and selected by the attending physician for performing a fluid challenge (FC) due to suspected tissue hypoperfusion. Receives: Other: Fluid challenge |
What is being measured
The primary outcome is the main question the study is designed to answer.
VO2-response
Percentage increase in VO2 as results of the fluid challenge
Measured: 30 minutes
Secondary outcomes (2)
Organ failure
Assessment of the SOFA score at day 1, 2 and 4
Measured: 4 days
Mortality
Mortality within the first 28 days
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2024
- Study start1 May 2024
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Septic ShockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Corporacion Parc Tauli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jaume Mesquida, Corporacion Parc Tauli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06500156
- Sponsor's protocol ID
- 20235121
- Acronym
- ACMEcat
- Status last verified
- Nov 2025
- First submitted
- 8 Jul 2024
- Last updated
- 5 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Cluster Analysis in Septic Shock Patients Undergoing Hemodynamic Resuscitation. A Multicenter Observational Study
- ClinicalTrials.gov ID
- NCT06500156
- Acronym / sponsor ID
- ACMEcat / 20235121
- Conditions
- Septic Shock
- Keywords
- septic shock, hemodynamic resuscitation, cardiovascular monitoring
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Corporacion Parc TauliUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 15 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Observational study including septic shock patients within 24 hours of ICU admission, monitored with a cardiac output estimation system, with ongoing resuscitation. Hemodynamic and metabolic parameters before and after a fluid challenge (FC) will be measured.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Septic shock | – | Other: Fluid challengeSeptic shock patients within the first 24 hours of ICU admission, and selected by the attending physician for performing a fluid challenge (FC) due to suspected tissue hypoperfusion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Septic shock patients within the first 24 hours of ICU admission, and selected by the attending physician for performing a fluid challenge (FC) due to suspected tissue hypoperfusion.
Key inclusion criteria (1 listed)
- Septic shock patients within the first 24 hours of ICU admission, and selected by the attending physician for performing a fluid challenge (FC) due to suspected tissue hypoperfusion (elevated lactate and/or ScvO2 < 70%).
Key exclusion criteria (3 listed)
- Age under 18 years old
- Uncontrolled hemodynamic instability, defined as the need for significant changes in vasopressor support (> 10% from baseline dose) within the 15-minute period prior to, and/or during the administration of fluids.
- Patients receiving continuous renal replacement therapies, since the CO values obtained from the thermodilution techniques might be potentially affected.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fluid challengeRapid infusion (< 15 minutes) of a fluid bolus of crystalloids (200 to 500cc) | Other | Septic shock |
Primary outcome
VO2-response
Time frame: 30 minutes
Percentage increase in VO2 as results of the fluid challenge
2 secondary outcomes
Organ failure
Time frame: 4 days
Mortality
Time frame: 28 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ferran Oller, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Septic Shock, run by Corporacion Parc Tauli at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jaume Mesquida, MD (+34937231010, jaume.mesquida@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VO2-response (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2025.