ShockNCT06481839
Impact of Starting Dose of Vasopressor on Hemodynamic Response in Shock
A study testing Starting dose of NE in people with Shock, run by University of Illinois Chicago.
Trial summary
This study is designed to assess the effect of initial vasopressor dose on clinical outcomes. To date, there are no clinical guidelines or recommendations regarding the dose of vasopressor medication that should be initiated before titrating to a mean arterial pressure (MAP) in patients with circulatory shock. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shock
- What is being tested?
- Starting dose of NE
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 24 Jul 2024to 24 Jul 2028
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients at least 18 years old
- Patients who are diagnosed with shock (MAP < 65 mmHg) require the initiation of vasopressors
- Care provided in the ED or admission to the Medical Intensive Care Unit (MICU)
- Norepinephrine chosen as first-line vasopressor by the treating clinician
Who cannot join
- Patients who are receiving vasopressors or inotropes prior to UI Health hospital presentation/admission
- Baseline MAP >/= 65 mmHg
- Pregnant patients (checked as standard of care on admission)
- Prisoners.
- Immediate post-cardiac arrest patients
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
This study is designed to assess the effect of initial vasopressor dose on clinical outcomes. To date, there are no clinical guidelines or recommendations regarding the dose of vasopressor medication that should be initiated before titrating to a mean arterial pressure (MAP) in patients with circulatory shock. High heterogeneity and clinical equipoise regarding this variable exist in routine clinical practice. However, there is strong evidence that delays in achieving MAP goals lead to worse clinical outcomes. The study will randomize patients with circulatory shock to a low (5mcg/min of norepinephrine) or high (15mcg/min of norepinephrine) initial starting dose followed by the usual protocolized titration to MAP goal. The time to reach the goal MAP, organ dysfunction, hospital length of stay, and mortality will be measured for each group.
- Conditions
- Shock
- Being tested
- Starting dose of NE
- Medical subject headings
- Shock
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Starting dose of NEOther
Patients will be randomized to either low-dose (5mcg/min) or high-dose (15mcg/min) norepinephrine (NE) for their first vasopressor in shock.
| Study group | Role | What they receive |
|---|---|---|
| Low-dose NE | Active comparator | Not described Receives: Other: Starting dose of NE |
| High-dose NE | Active comparator | Not described Receives: Other: Starting dose of NE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean arterial blood pressure
Time to achieve and sustain a mean arterial pressor greater than or equal to 65 mmHg
Measured: During first shock episode, up to 28 days of shock episode.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2024
- Study start24 Jul 2024 (estimated)
- Primary completion24 Jul 2026 (estimated)
- Study completion24 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ShockStudies of the same condition, open and under way.
- More trials run by University of Illinois ChicagoThe sponsor's other registered studies.
- 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
- Sequential
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Scott Benken, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06481839
- Sponsor's protocol ID
- 2024-0748
- Status last verified
- Jun 2024
- First submitted
- 24 Jun 2024
- Last updated
- 1 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Starting Dose of Vasopressor on Hemodynamic Response in Shock
- ClinicalTrials.gov ID
- NCT06481839
- Acronym / sponsor ID
- 2024-0748
- Conditions
- Shock
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Study start
- 24 Jul 2024 (estimated)
- Primary completion
- 24 Jul 2026 (estimated)
- Study completion
- 24 Jul 2028 (estimated)
- First posted
- 1 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.
This study is designed to assess the effect of initial vasopressor dose on clinical outcomes. To date, there are no clinical guidelines or recommendations regarding the dose of vasopressor medication that should be initiated before titrating to a mean arterial pressure (MAP) in patients with circulatory shock. High heterogeneity and clinical equipoise regarding this variable exist in routine clinical practice. However, there is strong evidence that delays in achieving MAP goals lead to worse clinical outcomes. The study will randomize patients with circulatory shock to a low (5mcg/min of norepinephrine) or high (15mcg/min of norepinephrine) initial starting dose followed by the usual protocolized titration to MAP goal. The time to reach the goal MAP, organ dysfunction, hospital length of stay, and mortality will be measured for each group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low-dose NE | Active comparator | Other: Starting dose of NE |
| High-dose NE | Active comparator | Other: Starting dose of NE |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients at least 18 years old
- Patients who are diagnosed with shock (MAP < 65 mmHg) require the initiation of vasopressors
- Care provided in the ED or admission to the Medical Intensive Care Unit (MICU)
- Norepinephrine chosen as first-line vasopressor by the treating clinician
Key exclusion criteria (5 listed)
- Patients who are receiving vasopressors or inotropes prior to UI Health hospital presentation/admission
- Baseline MAP >/= 65 mmHg
- Pregnant patients (checked as standard of care on admission)
- Prisoners.
- Immediate post-cardiac arrest patients
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 |
|---|---|---|
| Starting dose of NEPatients will be randomized to either low-dose (5mcg/min) or high-dose (15mcg/min) norepinephrine (NE) for their first vasopressor in shock. | Other | High-dose NE, Low-dose NE |
Primary outcome
Mean arterial blood pressure
Time frame: During first shock episode, up to 28 days of shock episode.
Time to achieve and sustain a mean arterial pressor greater than or equal to 65 mmHg
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 1 Jul 2024.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Starting dose of NE in people with Shock, run by University of Illinois Chicago.
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 4 inclusion and 5 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 1 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
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 Scott Benken (312-355-4107, benken@uic.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean arterial blood pressure (time frame: During first shock episode, up to 28 days of shock episode.). 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 1 Jul 2024.