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

Sepsis Clinical Trial

— AGONIST  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01453270
• Other study ID #: AGONIST
• Status: Completed
• Phase: N/A
• First received: October 12, 2011
• Last updated: September 23, 2014
• Start date: November 2011
• Est. completion date: March 2014

Study information

• Verified date: September 2014
• Source: National University Hospital, Singapore
• Contact: n/a
• Is FDA regulated: No
• Health authority: Singapore: Domain Specific Review Boards
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Emergencies
• Sepsis
• Shock, Septic
• Toxemia

Intervention

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:
• 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.

Locations

Country	Name	City	State
Singapore	National University Hospital	Singapore

Sponsors (2)

Lead Sponsor	Collaborator
National University Hospital, Singapore	Singapore Clinical Research Institute

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lactate clearance >20%	Arterial lactate levels will be measured at 0 and 3 hours to determine degree of lactate clearance at 3 hours.	3 hours	No
Secondary	Total hospital cost		At discharge, death or 28 days, whichever occurs earlier	No