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Non-invasive Measurement of CO in Patients With Uncomplicated Sepsis

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ClinicalTrials.gov Identifier: NCT03728998
Recruitment Status : Completed
First Posted : November 2, 2018
Last Update Posted : April 26, 2019
Sponsor:
Information provided by (Responsible Party):
Medical Centre Leeuwarden

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.

Condition or disease Intervention/treatment Phase
Sepsis Other: Passive leg raise (PLR) Other: Clearsight non-invasive hemodynamic monitoring system Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
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?
Actual Study Start Date : May 1, 2018
Actual Primary Completion Date : March 23, 2019
Actual Study Completion Date : March 23, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis

Arm Intervention/treatment
PLR & Clearsight measurements
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)
Other: 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: 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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  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). [ Time Frame: 1 hour ]
    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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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03728998


Locations
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Netherlands
Medisch Centrum Leeuwarden
Leeuwarden, Netherlands
Sponsors and Collaborators
Medical Centre Leeuwarden
Investigators
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Principal Investigator: Ewoud ter Avest, MD, PhD Medisch Centrum Leeuwarden
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Responsible Party: Medical Centre Leeuwarden
ClinicalTrials.gov Identifier: NCT03728998    
Other Study ID Numbers: nWMO271
First Posted: November 2, 2018    Key Record Dates
Last Update Posted: April 26, 2019
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Medical Centre Leeuwarden:
Passive leg raise
Fluid responsiveness
Cardiac output, non-invasive
Emergency Department
Additional relevant MeSH terms:
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Sepsis
Toxemia
Infections
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes