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

Not Applicable

Completed

• Conditions: Shock, Septic; Sepsis
• Interventions: Device: NICOM; Other: Usual care

• Registration Number: NCT01453270
• Lead Sponsor: National University Hospital, Singapore

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.

Study Timeline

• Study First Submitted: 2011-10-12
• Study First Submitted QC: 2011-10-12
• Study First Posted: 2011-10-17
• Study Start: 2011-11
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-23
• Last Update Posted: 2014-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 122

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NICOM and PLR	NICOM	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.
Usual care	Usual care	-

Primary Outcome Measures

Name	Time	Method
Lactate clearance >20%	3 hours	Arterial lactate levels will be measured at 0 and 3 hours to determine degree of lactate clearance at 3 hours.

Secondary Outcome Measures

Name	Time	Method
Total hospital cost	At discharge, death or 28 days, whichever occurs earlier

Trial Locations

Locations (1)

National University Hospital; 🇸🇬 Singapore, Singapore