Non-invasive Measurement of CO in Patients With Uncomplicated Sepsis

NCT03728998 | Completed

• 1 other identifier: nWMO271
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Sepsis

Keywords

Passive leg raise; Fluid responsiveness; Cardiac output, non-invasive; Emergency Department

Outcome Measures

Primary Outcomes (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.

  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

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).

  1 hour

Study Arms (1)

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)

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

Interventions

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.

PLR & Clearsight measurements

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.

PLR & Clearsight measurements

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Age\<16
• 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

Sponsors & Collaborators

• Frisius Medisch Centrum: lead

Study Sites (1)

Medisch Centrum Leeuwarden

Leeuwarden, Netherlands

Location

MeSH Terms

Conditions

Sepsis; Emergencies

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Attributes

Study Officials

• Ewoud ter Avest, MD, PhD

  Medisch Centrum Leeuwarden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2018
• First Posted: November 2, 2018
• Study Start: May 1, 2018
• Primary Completion: March 23, 2019
• Study Completion: March 23, 2019
• Last Updated: April 26, 2019

Record last verified: 2018-06

Locations

NL (1)