Back to resultsNon-invasive Measurement of CO in Patients With Uncomplicated Sepsis
Primary Purpose
Sepsis
Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Passive leg raise (PLR)
Clearsight non-invasive hemodynamic monitoring system
Sponsored by
About this trial
This is an interventional screening trial for Sepsis focused on measuring Passive leg raise, Fluid responsiveness, Cardiac output, non-invasive, Emergency Department
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
- 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
Sites / Locations
- Medisch Centrum Leeuwarden
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
PLR & Clearsight measurements
Arm Description
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)
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT03728998
First Posted
July 17, 2018
Last Updated
April 25, 2019
Sponsor
Medical Centre Leeuwarden
1. Study Identification
Unique Protocol Identification Number
NCT03728998
Brief Title
Non-invasive Measurement of CO in Patients With Uncomplicated Sepsis
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?
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
May 1, 2018 (Actual)
Primary Completion Date
March 23, 2019 (Actual)
Study Completion Date
March 23, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical Centre Leeuwarden
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sepsis
Keywords
Passive leg raise, Fluid responsiveness, Cardiac output, non-invasive, Emergency Department
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PLR & Clearsight measurements
Arm Type
Other
Arm Description
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)
Intervention Type
Other
Intervention Name(s)
Passive leg raise (PLR)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Clearsight non-invasive hemodynamic monitoring system
Intervention Description
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.
Primary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
1 hour
Secondary Outcome Measure Information:
Title
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).
Description
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.
Time Frame
1 hour
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ewoud ter Avest, MD, PhD
Organizational Affiliation
Medisch Centrum Leeuwarden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medisch Centrum Leeuwarden
City
Leeuwarden
Country
Netherlands
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Non-invasive Measurement of CO in Patients With Uncomplicated Sepsis
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