Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2025-12-25 @ 1:22 AM
NCT ID:
NCT00975793
Eligibility Criteria:
Inclusion Criteria:
* Suspected or confirmed infection
* The presence of TWO or MORE of the following SIRS criteria:
* Core temperature \< 36.0 degC or \> 38.0 degC
* Heart rate \> 90 beats/minute
* Respiratory rate \> 20 breaths/minute or PaCO2 \< 32 mmHg or the requirement for mechanical ventilation for an acute process
* White blood cell count \> 12.0 or \< 4.0 x109/L or \> 10% immature band forms
* Evidence of either refractory hypotension OR hypoperfusion:
* Refractory hypotension is confirmed by the presence of a systolic blood pressure (SBP) \< 90 mmHg or mean arterial pressure (MAP) \< 65 mmHg after a 1000ml intravenous (IV) fluid challenge within 60 minutes (including IV fluids administered pre-hospital)
* Hypoperfusion is confirmed by the presence of a blood lactate concentration greater than or equal to 4.0 mmol/L
* First dose of IV antimicrobial therapy commenced prior to randomisation
Exclusion Criteria:
* Age \< 18 years
* Contra-indication to superior vena cava (SVC) CVC insertion
* Contra-indication to blood products (e.g. Jehovah's Witness)
* Inability to commence delivery of the EGDT protocol within 1 hour of randomisation or complete 6 hours of EGDT
* Haemodynamic instability due to active bleeding
* Pregnancy (confirmed or suspected)
* In-patient transfer from another acute health care facility
* An underlying disease process with a life expectancy of \< 90 days
* Death is deemed imminent and inevitable
* A "limitation of therapy" order has been documented restricting implementation of the study protocol or the treating clinician deems aggressive care unsuitable
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00975793
Study Brief:
Protocol Section:
NCT00975793