Clinical trial NCT01453270: Emergency Department Management of Sepsis Patients: A Goal-Oriented Non-Invasive Sepsis Trial
Official title: Emergency Department Management of Sepsis Patients: A Goal-Oriented Non-Invasive Sepsis Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sepsis
Shock, Septic
Keywords: Sepsis
Emergency medicine
Cardiac output
Stroke volume
Lactate
Lead sponsor: National University Hospital, Singapore
Sponsor class: OTHER
Collaborators: name: Singapore Clinical Research Institute
First posted: 2011-10-17
Enrollment: 122
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Lactate clearance >20%
timeFrame: 3 hours
Secondary outcomes:
measure: Total hospital cost
timeFrame: At discharge, death or 28 days, whichever occurs earlier
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National University Hospital
Study officials:
affiliation: National University Health System, Singapore
name: Win Sen Kuan, MBBS
role: PRINCIPAL_INVESTIGATOR
affiliation: National University Health System, Singapore
name: Irwani Ibrahim, MBBS
role: PRINCIPAL_INVESTIGATOR
affiliation: National University Health System, Singapore
name: Benjamin SH Leong, MBBS
role: PRINCIPAL_INVESTIGATOR
affiliation: National University Health System, Singapore
name: Malcolm Mahadevan, MBBS
role: STUDY_CHAIR
affiliation: Duke-NUS Graduate Medical School
name: Yin Bun Cheung, PhD
role: PRINCIPAL_INVESTIGATOR
References: