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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Passive leg raise (PLR) | Other | A PLR will simulate an autotransfusion of 250-300 cc.
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 hour |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
At presentation in the ED:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ewoud ter Avest, MD, PhD | Medisch Centrum Leeuwarden | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medisch Centrum Leeuwarden | Leeuwarden | Netherlands |
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| ID | Term |
|---|---|
| D018805 | Sepsis |
| D004630 | Emergencies |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
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|
| Clearsight non-invasive hemodynamic monitoring system | Other | 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. |
|
| 1 hour |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D020969 | Disease Attributes |