SepsisNCT03728998
Non-invasive Measurement of CO in Patients With Uncomplicated Sepsis
A study testing Passive leg raise (PLR) and Clearsight non-invasive hemodynamic monitoring system in people with Sepsis, run by Frisius Medisch Centrum at 1 site in Netherlands.
Trial summary
Little is known about the optimal fluid therapy of patients with uncomplicated sepsis. Most recommendations are extrapolated from studies performed in patients with septic shock. Therefore, it is unknown how effective our current fluid therapy is. Furthermore, current therapy is not tailored to individual needs. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Sepsis
- What is being tested?
- Passive leg raise (PLR) and Clearsight non-invasive hemodynamic monitoring system
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 May 2018to 23 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- At presentation in the ED:
- there has to be evidence of an infection: -temp <36 or >38 without an obvious cause for hypo-or hyperthermia
- There has to be evidence of organ dysfunction by the presence of at least one of the following criteria: altered mental state, hypoxia (spo2<94% or 5% lower than baseline), lactate >2 mmol/l in ABGA or VBGA directly drawn after presentation, hypotension (MAP<65 mmHg or SBP<100mmHg), or a respiratory rate>22/min.
Who cannot join
- Age<16
- Patients with septic shock (i.e. who remained hypotensive after fluid bolus administration, needing vasopressor therapy to obtain a MAP>65 in the presence of a lactate >2. (i.e. septic shock) These will be excluded afterwards, but will be shown in an inclusion flowchart.
- Subjects for whom it is impossible to obtain a reliable signal for Clearsight measurements.
- Increased abdominal pressures
- Need for immediate ventilatory support or surgery
- Presence of an acute cerebral event, acute coronary syndrome, acute pulmonary edema, status asthmaticus, active gastrointestinal bleed, trauma
- Known metastatic cancer
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Can Non-invasive Measurement of Cardiac Index, Stroke Volume and Systemic Vascular Resistance Contribute to Better Tailoring of Treatment in Patients Presenting With Sepsis to the ED?
Little is known about the optimal fluid therapy of patients with uncomplicated sepsis. Most recommendations are extrapolated from studies performed in patients with septic shock. Therefore, it is unknown how effective our current fluid therapy is. Furthermore, current therapy is not tailored to individual needs. The aim of the current study is to investigate the added value of non-invasive measurements of (dynamic) circulatory parameters in the treatment of a convenience sample of sepsis patients presenting to the ED.
- Conditions
- Sepsis
- Being tested
- Passive leg raise (PLR), Clearsight non-invasive hemodynamic monitoring system
- Keywords
- Passive leg raise, Fluid responsiveness, Cardiac output, non-invasive, Emergency Department
- Medical subject headings
- Sepsis, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Passive leg raise (PLR)Other
A PLR will simulate an autotransfusion of 250-300 cc.
- 1. Starting in semi-succumbed position (45 degree head-up)
- 2. PLR is performed by lowering head-end and putting a for this purpose designed device of 45 degrees under the patients legs. The PLR is non-invasive.
Clearsight non-invasive hemodynamic monitoring systemOther
3 baseline readings will be done for CO, CI, SV and SVR, separated by one minute intervals. Subsequently, the standardized passive leg-raise test will be performed and measurements of CO, CI, SV and SVR will be repeated at 30, 60, 90 and 120 seconds. Then the patient is repositioned to his original position, and after two minutes another reading of CO, CI, SV and SVR is done. Then all patients will receive a fluid challenge of 500cc natriumchloride 0.9% IV, considered as normal treatment/ common practice in our ED. 120 seconds after finishing the fluid challenge the final reading of CO, CI, SV and SVR is done.
| Study group | Role | What they receive |
|---|---|---|
| PLR & Clearsight measurements | Other | All patients 16years or older presenting to the ED with uncomplicated sepsis (see inclusion and exclusion criteria) will undergo a Passive Leg Raise (PLR, non-invasive) and multiple measurements by the Clearsight non-invasive hemodynamic monitoring system. Followed by a fluid challenge (common practice; non interventional) Receives: Other: Passive leg raise (PLR); Other: Clearsight non-invasive hemodynamic monitoring system |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of subjects in whom a passive leg raise test resulted in a 15% or more improvement in cardiac index measured by the Clearsight non-invasive hemodynamic monitoring system.
3 baseline readings will be done for CI separated by one minute intervals. Subsequently, the standardized passive leg-raise test will be performed and measurements of CI will be repeated at 30, 60, 90 and 120 seconds. Then the patient is repositioned to his original position, and after two minutes another reading of CI is done. A difference of 15% or more is found to be clinically significant.
Measured: 1 hour
Secondary outcomes (1)
The ability of non-invasively measured baseline CO, CI, SVR and SV to predict fluid-responsiveness correctly (measurements by the Clearsight non-invasive hemodynamic monitoring system).
3 baseline readings will be done for CO, CI, SV and SVR, separated by one minute intervals. Subsequently, the standardized passive leg-raise test will be performed and measurements of CO, CI, SV and SVR will be repeated at 30, 60, 90 and 120 seconds. Then the patient is repositioned to his original position, and after two minutes another reading of CO, CI, SV and SVR is done. Then all patients will receive a fluid challenge of 500cc natriumchloride 0.9% IV, considered as normal treatment/ common practice in our ED. 120 seconds after finishing the fluid challenge the final reading of CO, CI, SV and SVR is done.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2018
- Study start1 May 2018
- Primary completion23 Mar 2019
- Study completion23 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Frisius Medisch Centrum
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ewoud ter Avest, MD, PhD, Principal investigator, Medisch Centrum Leeuwarden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03728998
- Sponsor's protocol ID
- nWMO271
- Status last verified
- Jun 2018
- First submitted
- 17 Jul 2018
- Last updated
- 26 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Non-invasive Measurement of Cardiac Index, Stroke Volume and Systemic Vascular Resistance Contribute to Better Tailoring of Treatment in Patients Presenting With Sepsis to the ED?
- ClinicalTrials.gov ID
- NCT03728998
- Acronym / sponsor ID
- nWMO271
- Conditions
- Sepsis
- Keywords
- Passive leg raise, Fluid responsiveness, Cardiac output, non-invasive, Emergency Department
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Frisius Medisch CentrumUniversity, hospital or other
- Study start
- 1 May 2018 (actual)
- Primary completion
- 23 Mar 2019 (actual)
- Study completion
- 23 Mar 2019 (actual)
- First posted
- 2 Nov 2018 (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.
Little is known about the optimal fluid therapy of patients with uncomplicated sepsis. Most recommendations are extrapolated from studies performed in patients with septic shock. Therefore, it is unknown how effective our current fluid therapy is. Furthermore, current therapy is not tailored to individual needs. The aim of the current study is to investigate the added value of non-invasive measurements of (dynamic) circulatory parameters in the treatment of a convenience sample of sepsis patients presenting to the ED.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PLR & Clearsight measurements | Other | Other: Passive leg raise (PLR), Other: Clearsight non-invasive hemodynamic monitoring systemAll patients 16years or older presenting to the ED with uncomplicated sepsis (see inclusion and exclusion criteria) will undergo a Passive Leg Raise (PLR, non-invasive) and multiple measurements by the Clearsight non-invasive hemodynamic monitoring system. Followed by a fluid challenge (common practice; non interventional) |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- there has to be evidence of an infection: -temp <36 or >38 without an obvious cause for hypo-or hyperthermia
- There has to be evidence of organ dysfunction by the presence of at least one of the following criteria: altered mental state, hypoxia (spo2<94% or 5% lower than baseline), lactate >2 mmol/l in ABGA or VBGA directly drawn after presentation, hypotension (MAP<65 mmHg or SBP<100mmHg), or a respiratory rate>22/min.
Key exclusion criteria (8 listed)
- Age<16
- Patients with septic shock (i.e. who remained hypotensive after fluid bolus administration, needing vasopressor therapy to obtain a MAP>65 in the presence of a lactate >2. (i.e. septic shock) These will be excluded afterwards, but will be shown in an inclusion flowchart.
- Subjects for whom it is impossible to obtain a reliable signal for Clearsight measurements.
- Increased abdominal pressures
- Need for immediate ventilatory support or surgery
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 |
|---|---|---|
| Passive leg raise (PLR)A PLR will simulate an autotransfusion of 250-300 cc. * 1. Starting in semi-succumbed position (45 degree head-up) * 2. PLR is performed by lowering head-end and putting a for this purpose designed device of 45 degrees under the patients legs. The PLR is non-invasive. | Other | PLR & Clearsight measurements |
| Clearsight non-invasive hemodynamic monitoring system3 baseline readings will be done for CO, CI, SV and SVR, separated by one minute intervals. Subsequently, the standardized passive leg-raise test will be performed and measurements of CO, CI, SV and SVR will be repeated at 30, 60, 90 and 120 seconds. Then the patient is repositioned to his original position, and after two minutes another reading of CO, CI, SV and SVR is done. Then all patients will receive a fluid challenge of 500cc natriumchloride 0.9% IV, considered as normal treatment/ common practice in our ED. 120 seconds after finishing the fluid challenge the final reading of CO, CI, SV and SVR is done. | Other | PLR & Clearsight measurements |
Primary outcome
The percentage of subjects in whom a passive leg raise test resulted in a 15% or more improvement in cardiac index measured by the Clearsight non-invasive hemodynamic monitoring system.
Time frame: 1 hour
3 baseline readings will be done for CI separated by one minute intervals. Subsequently, the standardized passive leg-raise test will be performed and measurements of CI will be repeated at 30, 60, 90 and 120 seconds. Then the patient is repositioned to his original position, and after two minutes another reading of CI is done. A difference of 15% or more is found to be clinically significant.
1 secondary outcome
The ability of non-invasively measured baseline CO, CI, SVR and SV to predict fluid-responsiveness correctly (measurements by the Clearsight non-invasive hemodynamic monitoring system).
Time frame: 1 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2019.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Ewoud ter Avest, MD, PhD principal investigator
Medisch Centrum Leeuwarden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Passive leg raise (PLR) and Clearsight non-invasive hemodynamic monitoring system in people with Sepsis, run by Frisius Medisch Centrum at 1 site in Netherlands.
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 3 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: finished, as of the sponsor's last update on 26 Apr 2019. 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 Netherlands. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percentage of subjects in whom a passive leg raise test resulted in a 15% or more improvement in cardiac index measured by the Clearsight non-invasive hemodynamic monitoring system. (time frame: 1 hour). 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 26 Apr 2019.