Emergency Department Management of Sepsis Patients: A Goal-Oriented Non-Invasive Sepsis Trial (AGONIST)
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).
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Emergency Department Management of Sepsis Patients: A Goal-Oriented Non-Invasive Sepsis Trial|
- Lactate clearance >20% [ Time Frame: 3 hours ] [ Designated as safety issue: No ]Arterial lactate levels will be measured at 0 and 3 hours to determine degree of lactate clearance at 3 hours.
- Total hospital cost [ Time Frame: At discharge, death or 28 days, whichever occurs earlier ] [ Designated as safety issue: No ]
|Study Start Date:||November 2011|
|Estimated Study Completion Date:||May 2014|
|Estimated Primary Completion Date:||March 2014 (Final data collection date for primary outcome measure)|
Experimental: NICOM and PLR
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.
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.
Other Name: NICOM
|Active Comparator: Usual care||
Other: Usual care
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01453270
|Contact: Win Sen Kuan, MBBS||+65 81234842||Win_Sen_Kuan@nuhs.edu.sg|
|National University Hospital||Recruiting|
|Singapore, Singapore, 119074|
|Contact: Win Sen Kuan, MBBS +65 81234842 Win_Sen_Kuan@nuhs.edu.sg|
|Principal Investigator:||Win Sen Kuan, MBBS||National University Health System, Singapore|
|Principal Investigator:||Irwani Ibrahim, MBBS||National University Health System, Singapore|
|Principal Investigator:||Benjamin SH Leong, MBBS||National University Health System, Singapore|
|Study Chair:||Malcolm Mahadevan, MBBS||National University Health System, Singapore|
|Principal Investigator:||Yin Bun Cheung, PhD||Duke-NUS Graduate Medical School, Singapore|