Emergency Department Management of Sepsis Patients: A Goal-Oriented Non-Invasive Sepsis Trial

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether the use of a 3-hour protocol utilizing non-invasive hemodynamic optimization treatment strategy results in better outcome and lower hospital costs in patients who present with severe bloodstream infections to the Emergency Department (ED).

Detailed Description
-----------------
Severe sepsis is a syndrome where the body develops organ dysfunction secondary to uncontrolled inflammatory response to infection. Various resuscitation bundles have been formulated and practised to treat severe sepsis, such as early goal-directed therapy (EGDT). EGDT involves the insertion of invasive catheters in patients with severe sepsis or septic shock using serial measurements to guide therapy and achieve hemodynamic goals, such as mean arterial pressure (MAP), central venous pressure (CVP) and central venous oxygen saturation (ScvO2) by 6 hours. The drawbacks include the invasive nature of inserting these catheters with its complications and tedium to set up the equipment. A non-invasive approach using the Non-Invasive Cardiac Output Monitor (NICOM) and passive leg raising (PLR) maneuver to guide fluid and vasoactive agent therapy targeting fluid responsiveness and MAP may be able to achieve better outcome, measured by lactate clearance at 3 hours and at a lower hospitalization cost.

Official Title
-----------------
Emergency Department Management of Sepsis Patients: A Goal-Oriented Non-Invasive Sepsis Trial

Conditions
-----------------
Sepsis, Shock, Septic

Intervention / Treatment
-----------------
* Device: NICOM
* Other: Usual care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Fulfillment of at least 2 systemic inflammatory response syndrome (SIRS) criteria Suspected infection Serum lactate ≥3mmol/L Exclusion Criteria: Age below 21 years Known pregnancy Prisoners Do-not-attempt resuscitation status Known severe aortic insufficiency or severe anatomic abnormalities of the thoracic aorta Primary diagnosis of trauma, burns, active seizures, acute cerebral vascular accident, acute coronary syndrome, status asthmaticus, major cardiac arrhythmias, active gastrointestinal haemorrhage, seizure or drug overdose Requirement for immediate surgery Inability to do PLR (e.g. ankylosis of hip joint, severe sciatica) Treating physician deems aggressive care unsuitable Those unable to give informed consent and unable to comply with study requirements

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NICOM and PLR<br>A systematic approach to resuscitation started in the ED and using a step-wise approach to optimize cardiac preload, afterload, and contractility, thus optimizing oxygen delivery to the tissues will be applied to the intervention group using the Non-Invasive Cardiac Output Monitor (NICOM) and passive leg-raising (PLR) maneuver. | Device: NICOM<br>* Assessment of fluid responsiveness will be done using the non-invasive cardiac output monitor (NICOM) and passive leg-raising (PLR) maneuver to target mean arterial pressure of between 65mmHg and 90mmHg; and change in stroke volume index (SVI) less than 10%, prior to administration of fluid boluses.<br>|
| Active Comparator: Usual care<br> | Other: Usual care<br>* Usual care is given at the clinician's discretion in accordance with current best practice. Standard treatment may involve treatment with intravenous fluids, and medications to support the blood pressure and heart.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lactate clearance >20% | Arterial lactate levels will be measured at 0 and 3 hours to determine degree of lactate clearance at 3 hours. | 3 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total hospital cost |  | At discharge, death or 28 days, whichever occurs earlier | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cardiac output, Sepsis, Emergency medicine, Stroke volume, Lactate