ISRCTN36307479
Completed
未知
A multicentre, randomised controlled trial of the clinical and cost-effectiveness of early, goal-directed, protocolised resuscitation for emerging septic shock
Intensive Care National Audit and Research Centre (ICNARC) (UK)0 sites1,260 target enrollmentNovember 19, 2009
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Severe sepsis/septic shock
- Sponsor
- Intensive Care National Audit and Research Centre (ICNARC) (UK)
- Enrollment
- 1260
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Greater than or equal to 18 years of age, either sex
- •2\. Known or presumed infection
- •3\. Two or more systemic inflammatory response syndrome (SIRS) criteria:
- •3\.1\. Core temperature less than or equal to 36°C or greater than or equal to 38°C
- •3\.2\. Heart rate greater than or equal to 90 beats/min
- •3\.3\. Respiratory rate greater than or equal to 20 breaths/min (or hyperventilation indicated by partial pressure of carbon dioxide in arterial blood \[PaCO2] 4\.3 kPa or mechanical ventilation for an acute process)
- •3\.4\. White blood cell count less than or equal to 4 x 10^9 l or greater than or equal to 12 x 10^9 l (or the presence of greater than 10% immature neutrophils bands)
- •4\. Refractory hypotension or hypoperfusion:
- •4\.1\. Hypotension is confirmed by the presence of systolic blood pressure less than 90 mmHg despite an intravenous (IV) fluid challenge of at least 20 ml/kg within 30 minutes of Emergency Department (ED) arrival (including IV fluids administered by pre\-hospital/Emergency Medical Services \[EMS] personnel)
- •4\.2\. Hypoperfusion is confirmed by a blood lactate concentration greater than or equal to 4 mmol/L)
Exclusion Criteria
- •Current exclusion criteria as of 04/01/2013:
- •1\. Age less than 18 years
- •2\. Known pregnancy
- •3\. Primary diagnosis of:
- •3\.1\. an acute cerebral vascular event
- •3\.2\. acute coronary syndrome
- •3\.3\. acute pulmonary oedema
- •3\.4\. status asthmaticus
- •3\.5\. major cardiac arrhythmia (as part of primary diagnosis)
- •3\.6\. seizure
Outcomes
Primary Outcomes
Not specified
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