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 @ 3:47 AM
Ignite Modification Date:
2025-12-25 @ 3:47 AM
NCT ID:
NCT03677102
Eligibility Criteria:
Inclusion Criteria:
* patients 16 years or greater who meet all of the following:
* require fluid resuscitation for refractory hypotension (systolic blood pressure \<90 mmHg or mean arterial blood pressure\<65 mmHg after 1 Litre bolus over 1 hour or less or organ hypo-perfusion (serum lactate \>4 mmol/L)
* have a clinical suspicion of infection
* are within 6 hours of hospital admission or critical care response team consultation
* are anticipated to require ICU admission
Exclusion Criteria:
* intracranial bleed or intracranial hypertension during the index hospital admission
* 10% of body surface area acute burn injury
* bleeding/hemorrhage as likely cause of hypotension
* a lack of commitment to life support
* have previously enrolled in FISSH, or a confounding trial (e.g. a trial examining the effect of other intravenous fluids in septic shock patients)
* been transferred from another hospital or facility \>6 hours since presentation to first hospital
* pre-established end stage renal disease (ESRD) or are receiving hemodialysis (intermittent or continuous) at time of enrolment, or
* been admitted to ICU directly from the operating room or post anaesthetic care unit
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Study:
NCT03677102
Study Brief:
Protocol Section:
NCT03677102