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Completed

NCT Number: NCT01453270

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

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).

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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National University Hospital

Singapore, 119074

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NICOM

Device

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.

Usual Care

Other

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.

Primary outcomes

  1. Lactate clearance >20%

    Time frame: 3 hours

    Arterial lactate levels will be measured at 0 and 3 hours to determine degree of lactate clearance at 3 hours.

Secondary outcomes

  1. Total hospital cost

    Time frame: At discharge, death or 28 days, whichever occurs earlier

Sponsors and collaborators

Lead sponsor

National University Hospital, Singapore

Other

Collaborators

  • Singapore Clinical Research Institute

Registry information

Acronym: AGONIST

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Oct 17, 2011
Registry last updated
Sep 25, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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