Emergency Department Management of Sepsis Patients: A Goal-Oriented Non-Invasive Sepsis Trial (AGONIST)
Primary Purpose
Sepsis, Shock, Septic
Status
Completed
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
NICOM
Usual care
Sponsored by
About this trial
This is an interventional treatment trial for Sepsis focused on measuring Sepsis, Emergency medicine, Cardiac output, Stroke volume, Lactate
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
Sites / Locations
- National University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
NICOM and PLR
Usual care
Arm 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.
Outcomes
Primary Outcome Measures
Lactate clearance >20%
Arterial lactate levels will be measured at 0 and 3 hours to determine degree of lactate clearance at 3 hours.
Secondary Outcome Measures
Total hospital cost
Full Information
NCT ID
NCT01453270
First Posted
October 12, 2011
Last Updated
September 23, 2014
Sponsor
National University Hospital, Singapore
Collaborators
Singapore Clinical Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT01453270
Brief Title
Emergency Department Management of Sepsis Patients: A Goal-Oriented Non-Invasive Sepsis Trial
Acronym
AGONIST
Official Title
Emergency Department Management of Sepsis Patients: A Goal-Oriented Non-Invasive Sepsis Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
March 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National University Hospital, Singapore
Collaborators
Singapore Clinical Research Institute
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sepsis, Shock, Septic
Keywords
Sepsis, Emergency medicine, Cardiac output, Stroke volume, Lactate
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
122 (Actual)
8. Arms, Groups, and Interventions
Arm Title
NICOM and PLR
Arm Type
Experimental
Arm 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.
Arm Title
Usual care
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
NICOM
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Usual care
Intervention Description
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.
Primary Outcome Measure Information:
Title
Lactate clearance >20%
Description
Arterial lactate levels will be measured at 0 and 3 hours to determine degree of lactate clearance at 3 hours.
Time Frame
3 hours
Secondary Outcome Measure Information:
Title
Total hospital cost
Time Frame
At discharge, death or 28 days, whichever occurs earlier
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Win Sen Kuan, MBBS
Organizational Affiliation
National University Health System, Singapore
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Irwani Ibrahim, MBBS
Organizational Affiliation
National University Health System, Singapore
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Benjamin SH Leong, MBBS
Organizational Affiliation
National University Health System, Singapore
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Malcolm Mahadevan, MBBS
Organizational Affiliation
National University Health System, Singapore
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Yin Bun Cheung, PhD
Organizational Affiliation
Duke-NUS Graduate Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
National University Hospital
City
Singapore
ZIP/Postal Code
119074
Country
Singapore
12. IPD Sharing Statement
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Emergency Department Management of Sepsis Patients: A Goal-Oriented Non-Invasive Sepsis Trial
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