Septic ShockNCT05225402
Hemodynamic Measurements of Macrocirculatory and Perfusion Parameters in ICU
An observational study of Septic Shock and Hemodynamic Instability, run by Copenhagen University Hospital, Hvidovre at 1 site in Denmark.
Trial summary
In septic shock there is growing evidence of a state of hemodynamic "disconnection" with seemingly adequate macrocirculatory values despite actual microcirculation failing to meet cellular demand. Norepinephrine (NE) is recommended as first choice vasoactive agent for the treatment of septic shock. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Septic Shock, Hemodynamic Instability, Vasoconstriction
- What is being tested?
- Hemodynamic measurements during reduction in Norepinephrine and fluid boli.
- Type of treatment
- Injection or infusion
- How many people
- 45 participants
- Where
- 1 siteDenmark
- Study dates
- 8 Mar 2022to 30 Dec 2025
- 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: 45 adult patients with septic shock according to inclusion criteria admitted to ICUs at Hvidovre and Bispebjerg Hospital, respectively.
Who may be able to join
- Suspected or documented infection
- Need for vasopressors to maintain mean arterial blood pressure (MAP) ≥65 mmHg
- Serum lactate levels >2 mmol/L
- Norepinephrine infusion of > 0.2 mcg/kg/min
Who cannot join
- Absolute contraindication for esophageal doppler or urinary catheter insertion as noted in the patients' charts.
- Severe valvular pathology and cardiac arrhythmias resulting in severe hemodynamic instability.
- Lithium treatment
- Treatment with other vasopressor or inotropic drugs.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Nicolai Bang Foss, MD, DMsC contact
Denmark1 site, 1 recruiting
- Recruiting
Hvidovre Hospital
Hvidovre, Copenhagen, 2665
Henrik Wolsted, 21494485, Hwolsted@gmail.com
About this study
Official title: Effects of Norepinephrine on Hemodynamic Measurements of Macrocirculatory and Perfusion Parameters in ICU Patients with Septic Shock
In septic shock there is growing evidence of a state of hemodynamic "disconnection" with seemingly adequate macrocirculatory values despite actual microcirculation failing to meet cellular demand. Norepinephrine (NE) is recommended as first choice vasoactive agent for the treatment of septic shock. However, the dynamic effects of NE on macro- and microcirculation and perfusion parameters has not been described in detail in the context of septic shock, precluding rational individualized titration of NE and fluids, as recommended recently. In the present prospective observational multicenter study in adult septic shock patients, we intend to explore the effects of NE on preload dependency and tissue perfusion by evaluating the correlation and potential discrepancies between macro- and microcirculation both during titration of NE and after fluid resuscitation. The conclusions drawn from our study will contribute to the physiological knowledge necessary for establishing individualized evidence-based bedside management of hemodynamics in the setting of septic shock.
- Conditions
- Septic Shock, Hemodynamic Instability, Vasoconstriction
- Being tested
- Hemodynamic measurements during reduction in Norepinephrine and fluid boli.
- Keywords
- Septic Shock, Norepinephrine, Hemodynamic, Microcirculation, Intensive Care
- Medical subject headings
- Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hemodynamic measurements during reduction in Norepinephrine and fluid boli.Drug
- Extended monitoring equipment will be connected to the patient. Clinical and biochemical parameters will be collected for a baseline before the next step. A Safety check will be performed to ensure correct patient data, correct equipment function and safety measures are meet. A passive leg raise test will be performed to predict fluid responsiveness, in case of a positive test, a fluid challenge will be administered.
- A stepwise reduction of the NE infusion rate from baseline while monitoring stroke volume (SV) to elucidate changes in SV and potential preloadresponsiveness. The reduction will occur in steps of 3-5 minute until either discontinuation of the norepinephrine infusion, a 50% reduction in SV or MAP<40.
- While maintaining the NE infusion rate from the previous step 2, a fluid challenge will be administrated, until additional fluid does not increase SV>10%.
- As in step 2, a stepwise increase in NE infusion rate to the baseline infusion level or the baseline BP.
| Study group | Role | What they receive |
|---|---|---|
| Septic Shock | Adult patients with septic shock, admitted to ICUs at Hvidovre and Bispebjerg Hospital, respectively. Sedated and mechanically ventilated adult patients (>18 years). Receives: Drug: Hemodynamic measurements during reduction in Norepinephrine and fluid boli. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preload responsiveness defined as stroke volume increase > 10%, measured by continuous arterial waveform analysis.
The number of patients who were preload responsive after down-titration of NE.
Measured: Through study completion, an average of 1 year
Secondary outcomes (3)
Cardiac output response measured by lithium indicator dilution and Doppler ultrasound.
The effect on cardiac output after fluid bolus and subsequent up-titration of NE to the pre-intervention blood pressure target.
Measured: Through study completion, an average of 1 year
Microcirculation/perfusion measures during intervention.
The effect of the intervention on measures of tissue perfusion. Different topical sites (Brain, Muscle, Finger, Urethra, Sublingual) by minimal- or noninvasive methods.
Measured: Through study completion, an average of 1 year
CO measurement method
Assess the correlation between indirect measurements of CO and lithium dilution measured CO during NE titration.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2022
- Study start8 Mar 2022
- Primary completion30 Jul 2025 (estimated)
- Study completion30 Dec 2025 (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
- Other
- Time perspective
- Prospective
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Hvidovre
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Bispebjerg and Frederiksberg
- Responsible party
- Principal investigator, Henrik Wolsted, Copenhagen University Hospital, Hvidovre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05225402
- Sponsor's protocol ID
- HW-NA-Fluid-Measurements
- Status last verified
- Mar 2025
- First submitted
- 12 Jan 2022
- Last updated
- 7 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Norepinephrine on Hemodynamic Measurements of Macrocirculatory and Perfusion Parameters in ICU Patients with Septic Shock
- ClinicalTrials.gov ID
- NCT05225402
- Acronym / sponsor ID
- HW-NA-Fluid-Measurements
- Conditions
- Septic Shock, Hemodynamic Instability, Vasoconstriction
- Keywords
- Septic Shock, Norepinephrine, Hemodynamic, Microcirculation, Intensive Care
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, HvidovreUniversity, hospital or other
- Collaborators
- University Hospital Bispebjerg and Frederiksberg
- Study start
- 8 Mar 2022 (actual)
- Primary completion
- 30 Jul 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 4 Feb 2022 (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.
In septic shock there is growing evidence of a state of hemodynamic "disconnection" with seemingly adequate macrocirculatory values despite actual microcirculation failing to meet cellular demand. Norepinephrine (NE) is recommended as first choice vasoactive agent for the treatment of septic shock. However, the dynamic effects of NE on macro- and microcirculation and perfusion parameters has not been described in detail in the context of septic shock, precluding rational individualized titration of NE and fluids, as recommended recently. In the present prospective observational multicenter study in adult septic shock patients, we intend to explore the effects of NE on preload dependency and tissue perfusion by evaluating the correlation and potential discrepancies between macro- and microcirculation both during titration of NE and after fluid resuscitation. The conclusions drawn from our study will contribute to the physiological knowledge necessary for establishing individualized evidence-based bedside management of hemodynamics in the setting of septic shock.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Septic Shock | – | Drug: Hemodynamic measurements during reduction in Norepinephrine and fluid boli.Adult patients with septic shock, admitted to ICUs at Hvidovre and Bispebjerg Hospital, respectively. Sedated and mechanically ventilated adult patients (>18 years). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 45 adult patients with septic shock according to inclusion criteria admitted to ICUs at Hvidovre and Bispebjerg Hospital, respectively.
Key inclusion criteria (4 listed)
- Suspected or documented infection
- Need for vasopressors to maintain mean arterial blood pressure (MAP) ≥65 mmHg
- Serum lactate levels >2 mmol/L
- Norepinephrine infusion of > 0.2 mcg/kg/min
Key exclusion criteria (4 listed)
- Absolute contraindication for esophageal doppler or urinary catheter insertion as noted in the patients' charts.
- Severe valvular pathology and cardiac arrhythmias resulting in severe hemodynamic instability.
- Lithium treatment
- Treatment with other vasopressor or inotropic drugs.
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 |
|---|---|---|
| Hemodynamic measurements during reduction in Norepinephrine and fluid boli.1. Extended monitoring equipment will be connected to the patient. Clinical and biochemical parameters will be collected for a baseline before the next step. A Safety check will be performed to ensure correct patient data, correct equipment function and safety measures are meet. A passive leg raise test will be performed to predict fluid responsiveness, in case of a positive test, a fluid challenge will be administered. 2. A stepwise reduction of the NE infusion rate from baseline while monitoring stroke volume (SV) to elucidate changes in SV and potential preloadresponsiveness. The reduction will occur in steps of 3-5 minute until either discontinuation of the norepinephrine infusion, a 50% reduction in SV or MAP<40. 3. While maintaining the NE infusion rate from the previous step 2, a fluid challenge will be administrated, until additional fluid does not increase SV>10%. 4. As in step 2, a stepwise increase in NE infusion rate to the baseline infusion level or the baseline BP. | Drug | Septic Shock |
Primary outcome
Preload responsiveness defined as stroke volume increase > 10%, measured by continuous arterial waveform analysis.
Time frame: Through study completion, an average of 1 year
The number of patients who were preload responsive after down-titration of NE.
3 secondary outcomes
Cardiac output response measured by lithium indicator dilution and Doppler ultrasound.
Time frame: Through study completion, an average of 1 year
Microcirculation/perfusion measures during intervention.
Time frame: Through study completion, an average of 1 year
CO measurement method
Time frame: Through study completion, an average of 1 year
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 7 Mar 2025.
- 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.
Nicolai Bang Foss, MD, DMsC 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 and Hemodynamic Instability, run by Copenhagen University Hospital, Hvidovre at 1 site in Denmark.
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 4 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 7 Mar 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 Denmark. 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 Henrik Wolsted, MD (+45 21 49 44 85, Henrik.wolsted.01@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preload responsiveness defined as stroke volume increase > 10%, measured by continuous arterial waveform analysis. (time frame: Through study completion, an average of 1 year). 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 7 Mar 2025.