Non-invasive Measurement of CO in Patients With Uncomplicated Sepsis

NCT ID: NCT03728998

Last Updated: 2019-04-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-01
• Study Completion Date: 2019-03-23

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

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)

Group Type: OTHER

Passive leg raise (PLR)

Intervention Type: 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.

Clearsight non-invasive hemodynamic monitoring system

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Frisius Medisch Centrum

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ewoud ter Avest, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Medisch Centrum Leeuwarden

Locations

Medisch Centrum Leeuwarden

Leeuwarden, , Netherlands

Countries

Netherlands

Other Identifiers

nWMO271

Identifier Type: -

Identifier Source: org_study_id