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

This study has been completed.
Sponsor:
Collaborator:
Singapore Clinical Research Institute
Information provided by (Responsible Party):
National University Hospital, Singapore
ClinicalTrials.gov Identifier:
NCT01453270
First received: October 12, 2011
Last updated: September 23, 2014
Last verified: September 2014
  Purpose

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).


Condition Intervention
Sepsis
Shock, Septic
Device: NICOM
Other: Usual care

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by National University Hospital, Singapore:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • Total hospital cost [ Time Frame: At discharge, death or 28 days, whichever occurs earlier ] [ Designated as safety issue: No ]

Enrollment: 122
Study Start Date: November 2011
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Device: NICOM
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.

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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01453270

Locations
Singapore
National University Hospital
Singapore, Singapore, 119074
Sponsors and Collaborators
National University Hospital, Singapore
Singapore Clinical Research Institute
Investigators
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
  More Information

No publications provided

Responsible Party: National University Hospital, Singapore
ClinicalTrials.gov Identifier: NCT01453270     History of Changes
Other Study ID Numbers: AGONIST
Study First Received: October 12, 2011
Last Updated: September 23, 2014
Health Authority: Singapore: Domain Specific Review Boards

Keywords provided by National University Hospital, Singapore:
Sepsis
Emergency medicine
Cardiac output
Stroke volume
Lactate

Additional relevant MeSH terms:
Emergencies
Sepsis
Toxemia
Shock, Septic
Disease Attributes
Pathologic Processes
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Shock

ClinicalTrials.gov processed this record on October 19, 2014