Sepsis, Shock, Septic
Conditions
Keywords
Sepsis, Emergency medicine, Cardiac output, Stroke volume, Lactate
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.
Interventions
DEVICENICOM
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.
OTHERUsual 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.
Sponsors
Singapore Clinical Research Institute
National University Hospital, Singapore
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| Total hospital cost | At discharge, death or 28 days, whichever occurs earlier |
Countries
Singapore
Outcome results
None listed