Emergency Department Management of Sepsis Patients: A Goal-Oriented Non-Invasive Sepsis Trial (AGONIST)
|ClinicalTrials.gov Identifier: NCT01453270|
Recruitment Status : Completed
First Posted : October 17, 2011
Last Update Posted : September 25, 2014
|Condition or disease||Intervention/treatment||Phase|
|Sepsis Shock, Septic||Device: NICOM Other: Usual care||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||122 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Emergency Department Management of Sepsis Patients: A Goal-Oriented Non-Invasive Sepsis Trial|
|Study Start Date :||November 2011|
|Actual Primary Completion Date :||March 2014|
|Actual Study Completion Date :||March 2014|
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.
|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.
- Lactate clearance >20% [ Time Frame: 3 hours ]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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01453270
|National University Hospital|
|Singapore, Singapore, 119074|
|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|