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 @ 1:46 AM
Ignite Modification Date:
2025-12-25 @ 1:46 AM
NCT ID:
NCT03048994
Eligibility Criteria:
Inclusion Criteria
* All adult patients (\>18 years old) admitted to ICU plus
* Severe sepsis defined as 2 or more or the following
* Temperature \>38oC or \< 36oC
* Heart rate \> 90 beats per min
* Respiratory rate \>20 breaths per min or PaCO2 \<32 mmHg
* White cell count \> 12,000/microL or \< 4,000/microL
* PLUS presence or presumed presence of infection
* PLUS evidence of organ dysfunction as defined by either of the following
* Hemodynamic: Hypotension = systolic blood pressure (SBP) 40 mm Hg or mean arterial pressure (MAP) \< 65 mm Hg; or on vasopressors
* Hyperlactatemia: Serum lactate \>/= 2 mmol/L (18 mg/dL)
* Renal: Acute increase in serum creatinine to \> 176.8 mmol/L (2.0 mg/dL) or urine output \< 0.5 mL/kg/hour for \> 2 hours
* Lung: Acute lung injury with PaO2/FiO2 \</=300mmHg
* Liver: Acute increase in bilirubin to \>/= 34.2 umol/L (2 mg/dL)
* Thrombocytopenia: Acute decrease in platelet count to \< 100,000 cells/mm3
* Coagulopathy: International normalized ratio (INR) \> 1.5 or a partial thromboplastin time (aPTT) \> 60 secs which is not due to anticoagulant therapy
* Exclusion criteria
* \>48hr from admission to ICU
* Patients who are not expected to survive \>48hrs by the managing team
* Refusal to consent to study
* Allergic to glutamine or its constituents
* Absolute contraindication to enteral nutrition or the need to initiate parenteral nutrition
* Patients with a primary admission diagnosis of burns (\>30% body surface area)
* Patients whose weight \<40kg or \>200kg
* Previous randomization to this study
* Enrolled in a related ICU interventional nutrition study
* Pregnant patients or lactating mothers with the intent to breastfeed
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
99 Years
Study:
NCT03048994
Study Brief:
Protocol Section:
NCT03048994