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

National University Health System (NUHS)

Status: Completed

Conditions: Shock, Septic; Sepsis

Treatments: Device: NICOM; Other: Usual care

Study type: Interventional

Funder types: Other

Identifiers

NCT01453270

AGONIST

Details and patient eligibility

About

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).

Full 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.

Enrollment: 122 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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122 participants in 2 patient groups

NICOM and PLR

Experimental group

Description:

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.

Treatment:

Device: NICOM

Usual care

Active Comparator group

Treatment:

Other: Usual care