Non-invasive Measurement of CO in Patients With Uncomplicated Sepsis

Medical Centre Leeuwarden

Status: Completed

Conditions: Sepsis

Treatments: Other: Passive leg raise (PLR); Other: Clearsight non-invasive hemodynamic monitoring system

Study type: Interventional

Funder types: Other

Identifiers

NCT03728998

nWMO271

Details and patient eligibility

About

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.

Enrollment: 31 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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31 participants in 1 patient group

PLR & Clearsight measurements

Other group

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)

Treatment:

Other: Clearsight non-invasive hemodynamic monitoring system

Other: Passive leg raise (PLR)