Septic ShockEaDynNCT06118775
Evaluating Dynamic Arterial Elastance in Septic Shock Patients.
A study testing EaDyn Weaning Arm: and PAM Weaning Arm: in people with Septic Shock, run by Fundación Santa Fe de Bogota at 1 site in Colombia.
Trial summary
Assess the effectiveness and safety of using dynamic arterial elastance as a tool for weaning vasopressor support in patients with septic shock, compared to a control group Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Septic Shock
- What is being tested?
- EaDyn Weaning Arm: and PAM Weaning Arm:
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteColombia
- Study dates
- 1 Mar 2025to 1 Jul 2026
- Phase
- Interventional
- 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 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 18 years of age.
- Admission to the ICU.
- Septic shock defined according to the Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3).
- Hypotension requiring vasopressor support to maintain a MAP ≥ 65 mmHg.
- SOFA score ≥ 4.
- Vasopressor support duration ≥ 4 hours.
- Patients requiring mechanical ventilation.
- Patients who have reached the hemodynamic stabilization phase and are ready to begin the vasopressor weaning process with norepinephrine, defined as: mean arterial pressure (MAP) > 75 mmHg, cardiac index (CI) > 2.5 L/min/m², and lactate level < 2 mmol/L.
Who cannot join
- Pregnant individuals.
- Hemodynamic instability due to cardiac arrhythmias.
- Hepatic cirrhosis.
- Kidney or liver transplant.
- High probability of mortality within 24 hours, according to medical judgment.
- Left ventricular ejection fraction (LVEF) less than 50%.
- Right ventricular dysfunction, defined as a TAPSE (Tricuspid Annular Plane Systolic Excursion) measurement of less than 1.6 cm.
- Patients spontaneously breathing.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Colombia1 site
Jorge Iván Alvarad
Bogotá
Jorge Alvarado, jialvarados@unal.edu.co
3017858459
About this study
Official title: Assessment of the Effectiveness and Safety of Dynamic Arterial Elastance in Weaning Vasopressor Support in Patients with Septic Shock: a Randomized Controlled Clinical Trial At Santa Fé Foundation in Bogotá
Assess the effectiveness and safety of using dynamic arterial elastance as a tool for weaning vasopressor support in patients with septic shock, compared to a control group
Read the detailed description
An open-label, randomized controlled clinical trial will be conducted with two patient groups. Our hypothesis is that using dynamic arterial elastance (EaDyn) as a tool to guide vasopressor weaning can reduce the duration of vasopressor support. Eligible patients will be randomly assigned to either the EaDyn weaning arm or the mean arterial pressure (MAP) weaning arm in a 1:1 ratio. Blinding of participants and investigators will not be possible due to the study's methodology. The analysis will be conducted on an intention-to-treat basis.
- Conditions
- Septic Shock
- Being tested
- EaDyn Weaning Arm:, PAM Weaning Arm:
- Keywords
- Dynamic arterial elastance (EaDyn)., vasopressor weaning., septic shock.
- Medical subject headings
- Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EaDyn Weaning Arm:Procedure or surgery
The initiation of vasopressor weaning coincides with the beginning of the stabilization phase, which occurs when patients achieve a MAP >75 mmHg, a cardiac index (CI) >2.5 L/min/m², and a lactate level <2 mmol/L. The norepinephrine dose will be gradually tapered, decreasing by 0.02 mcg/kg/min every 30 minutes. In the experimental group, vasopressor weaning is guided by the EaDyn value. Weaning can proceed as long as the EaDyn remains at or above 0.90. However, if the value drops below 0.90, the weaning process halts, and the norepinephrine dose is reverted to the last dose where the EaDyn value was ≥ 0.90. Regardless of the EaDyn value, any patient experiencing a MAP decline below 50 mmHg will be withdrawn from the study. Should the MAP range between 50 mmHg and 69 mmHg, a fluid challenge of 250 mL of isotonic crystalloid must be administered before weaning continues.
PAM Weaning Arm:Procedure or surgery
The initiation of vasopressor weaning coincides with the beginning of the stabilization phase, which occurs when patients achieve a MAP >75 mmHg, a cardiac index (CI) >2.5 L/min/m², and a lactate level <2 mmol/L. The norepinephrine dose will be gradually tapered, decreasing by 0.02 mcg/kg/min every 30 minutes. In the control group, vasopressor weaning progresses as long as the MAP remains at or above 70 mmHg. If the MAP falls between 50 and 69 mmHg, preload dependency is reassessed. Upon confirmation, a new fluid challenge is administered; vasopressor weaning halts, and the vasopressor dose reverts to its prior value. The weaning process can continue as long as the patient's MAP remains above 50 mmHg. If the MAP drops below this threshold, the patient exits the study.
| Study group | Role | What they receive |
|---|---|---|
| EaDyn weaning arm | Experimental | In the EaDyn weaning arm of the study, dynamic arterial elastance (EaDyn) will be utilized as a specialized hemodynamic tool to guide the gradual reduction of vasopressor support in patients diagnosed with septic shock. EaDyn, a measure of the relationship between arterial pressure and stroke volume variation over the cardiac cycle, provides valuable insights into vascular tone and cardiac performance Receives: Procedure: EaDyn Weaning Arm: |
| PAM weaning arm | Active comparator | In the PAM (Mean Arterial Pressure) weaning arm of the study, mean arterial pressure (MAP) will be used as the primary parameter to guide the gradual reduction of vasopressor support in patients diagnosed with septic shock. Mean arterial pressure represents the average pressure in the arteries during one cardiac cycle and is a crucial indicator of perfusion to vital organs. Participants in this group will be monitored continuously for their MAP values, allowing real-time assessment of their hemodynamic status. Receives: Procedure: PAM Weaning Arm: |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of vasopressor support
Defined as the time interval in hours from the initiation of vasopressor support to its discontinuation.
Measured: 30 days
Secondary outcomes (5)
Cumulative vasopressor dosage.
Total dose of norepinephrine administered from the initiation of vasopressor support to its discontinuation.
Measured: 30 days
Overall hospital length of stay in days
Length of stay in the hospital in days.
Measured: 90 days
Overall ICU length of stay in days.
Length of stay in the intensive care unit (ICU) in days.
Measured: 90 days.
Acute Kidney Injury (AKI).
Proportion of AKI assessed according to the Kidney Disease Improving Global Outcomes (KDIGO) guidelines.
Measured: 90 days.
Mortality
The number or percentage of deaths among patients diagnosed with septic shock during their hospitalization period.
Measured: 90 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study start1 Mar 2025 (estimated)
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- An open-label, pragmatic, parallel-group, controlled clinical trial will be conducted with two patient groups. Our hypothesis is that using EaDyn as a hemodynamic tool to guide vasopressor weaning can reduce the duration of vasopressor support. Patients meeting the inclusion criteria will be randomly assigned to one of the two groups using computer-generated random numbers in a 1:1 ratio. In the first group, termed 'EaDyn weaning arm' (EaDyn), dynamic arterial elastance will be used as a tool for vasopressor weaning. In the second group, named 'PAM weaning arm,' mean arterial pressure will be used as the tool for vasopressor weaning. Due to the study's methodological characteristics, blinding of participants and investigators regarding group assignment will not be possible. Lastly, the study will be conducted on an intention-to-treat basis.
- Masking
- None (open label)
- Enrolment
- 114 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación Santa Fe de Bogota
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jorge Iván Alvarado, Fundación Santa Fe de Bogota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06118775
- Sponsor's protocol ID
- SECEC-2023-123
- Acronym
- EaDyn
- Status last verified
- Feb 2025
- First submitted
- 27 Oct 2023
- Last updated
- 24 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Alvarado Sanchez JI, Montanez-Narino AV, Cardenas-Bolivar YR, Stozitzky-Rios MV, Mora-Salamanca AF. Efficacy and safety of dynamic arterial elastance for weaning vasopressor support in septic shock patients: a randomised controlled trial protocol. BMJ Open. 2024 Aug 7;14(8):e086388. doi: 10.1136/bmjopen-2024-086388.
PubMed 39117412
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Effectiveness and Safety of Dynamic Arterial Elastance in Weaning Vasopressor Support in Patients with Septic Shock: a Randomized Controlled Clinical Trial At Santa Fé Foundation in Bogotá
- ClinicalTrials.gov ID
- NCT06118775
- Acronym / sponsor ID
- EaDyn / SECEC-2023-123
- Conditions
- Septic Shock
- Keywords
- Dynamic arterial elastance (EaDyn)., vasopressor weaning., septic shock.
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 114 participants (estimated)
- Lead sponsor
- Fundación Santa Fe de BogotaUniversity, hospital or other
- Study start
- 1 Mar 2025 (estimated)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 7 Nov 2023 (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.
Assess the effectiveness and safety of using dynamic arterial elastance as a tool for weaning vasopressor support in patients with septic shock, compared to a control group
Detailed description
An open-label, randomized controlled clinical trial will be conducted with two patient groups. Our hypothesis is that using dynamic arterial elastance (EaDyn) as a tool to guide vasopressor weaning can reduce the duration of vasopressor support. Eligible patients will be randomly assigned to either the EaDyn weaning arm or the mean arterial pressure (MAP) weaning arm in a 1:1 ratio. Blinding of participants and investigators will not be possible due to the study's methodology. The analysis will be conducted on an intention-to-treat basis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- An open-label, pragmatic, parallel-group, controlled clinical trial will be conducted with two patient groups. Our hypothesis is that using EaDyn as a hemodynamic tool to guide vasopressor weaning can reduce the duration of vasopressor support. Patients meeting the inclusion criteria will be randomly assigned to one of the two groups using computer-generated random numbers in a 1:1 ratio. In the first group, termed 'EaDyn weaning arm' (EaDyn), dynamic arterial elastance will be used as a tool for vasopressor weaning. In the second group, named 'PAM weaning arm,' mean arterial pressure will be used as the tool for vasopressor weaning. Due to the study's methodological characteristics, blinding of participants and investigators regarding group assignment will not be possible. Lastly, the study will be conducted on an intention-to-treat basis.
| Arm | Type | Receives |
|---|---|---|
| EaDyn weaning arm | Experimental | Procedure: EaDyn Weaning Arm:In the EaDyn weaning arm of the study, dynamic arterial elastance (EaDyn) will be utilized as a specialized hemodynamic tool to guide the gradual reduction of vasopressor support in patients diagnosed with septic shock. EaDyn, a measure of the relationship between arterial pressure and stroke volume variation over the cardiac cycle, provides valuable insights into vascular tone and cardiac performance |
| PAM weaning arm | Active comparator | Procedure: PAM Weaning Arm:In the PAM (Mean Arterial Pressure) weaning arm of the study, mean arterial pressure (MAP) will be used as the primary parameter to guide the gradual reduction of vasopressor support in patients diagnosed with septic shock. Mean arterial pressure represents the average pressure in the arteries during one cardiac cycle and is a crucial indicator of perfusion to vital organs. Participants in this group will be monitored continuously for their MAP values, allowing real-time assessment of their hemodynamic status. |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- ≥ 18 years of age.
- Admission to the ICU.
- Septic shock defined according to the Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3).
- Hypotension requiring vasopressor support to maintain a MAP ≥ 65 mmHg.
- SOFA score ≥ 4.
Key exclusion criteria (8 listed)
- Pregnant individuals.
- Hemodynamic instability due to cardiac arrhythmias.
- Hepatic cirrhosis.
- Kidney or liver transplant.
- High probability of mortality within 24 hours, according to medical judgment.
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 |
|---|---|---|
| EaDyn Weaning Arm:The initiation of vasopressor weaning coincides with the beginning of the stabilization phase, which occurs when patients achieve a MAP >75 mmHg, a cardiac index (CI) >2.5 L/min/m², and a lactate level <2 mmol/L. The norepinephrine dose will be gradually tapered, decreasing by 0.02 mcg/kg/min every 30 minutes. In the experimental group, vasopressor weaning is guided by the EaDyn value. Weaning can proceed as long as the EaDyn remains at or above 0.90. However, if the value drops below 0.90, the weaning process halts, and the norepinephrine dose is reverted to the last dose where the EaDyn value was ≥ 0.90. Regardless of the EaDyn value, any patient experiencing a MAP decline below 50 mmHg will be withdrawn from the study. Should the MAP range between 50 mmHg and 69 mmHg, a fluid challenge of 250 mL of isotonic crystalloid must be administered before weaning continues. | Procedure or surgery | EaDyn weaning arm |
| PAM Weaning Arm:The initiation of vasopressor weaning coincides with the beginning of the stabilization phase, which occurs when patients achieve a MAP >75 mmHg, a cardiac index (CI) >2.5 L/min/m², and a lactate level <2 mmol/L. The norepinephrine dose will be gradually tapered, decreasing by 0.02 mcg/kg/min every 30 minutes. In the control group, vasopressor weaning progresses as long as the MAP remains at or above 70 mmHg. If the MAP falls between 50 and 69 mmHg, preload dependency is reassessed. Upon confirmation, a new fluid challenge is administered; vasopressor weaning halts, and the vasopressor dose reverts to its prior value. The weaning process can continue as long as the patient's MAP remains above 50 mmHg. If the MAP drops below this threshold, the patient exits the study. | Procedure or surgery | PAM weaning arm |
Primary outcome
Duration of vasopressor support
Time frame: 30 days
Defined as the time interval in hours from the initiation of vasopressor support to its discontinuation.
5 secondary outcomes
Cumulative vasopressor dosage.
Time frame: 30 days
Overall hospital length of stay in days
Time frame: 90 days
Overall ICU length of stay in days.
Time frame: 90 days.
Acute Kidney Injury (AKI).
Time frame: 90 days.
Mortality
Time frame: 90 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 24 Feb 2025.
- Derived from this study: PubMed 39117412Alvarado Sanchez JI, Montanez-Narino AV, Cardenas-Bolivar YR, Stozitzky-Rios MV, Mora-Salamanca AF. Efficacy and safety of dynamic arterial elastance for weaning vasopressor support in septic shock patients: a randomised controlled trial protocol. BMJ Open. 2024 Aug 7;14(8):e086388. doi: 10.1136/bmjopen-2024-086388.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EaDyn Weaning Arm: and PAM Weaning Arm: in people with Septic Shock, run by Fundación Santa Fe de Bogota at 1 site in Colombia.
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 8 inclusion and 8 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: opening soon, as of the sponsor's last update on 24 Feb 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 Colombia. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of vasopressor support (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06118775, which also lists 1 linked publication.
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 24 Feb 2025.