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 @ 2:18 AM
Ignite Modification Date:
2025-12-25 @ 2:18 AM
NCT ID:
NCT01847534
Eligibility Criteria:
Inclusion Criteria:
Patients in intensive care who meet all of the following:
* Admitted to intensive care between 48 hours and 72 hours previously
* Mechanically ventilated at the time of enrollment and expected to remain ventilated until the day after tomorrow
* At least 16 years of age
* Have central venous access suitable for PN solution administration
* Have 1 or more organ system failure (respiratory, cardiovascular or renal) related to their acute illness defined as:
1. Partial pressure of oxygen (PaO2) / Fraction of Inspired oxygen (FiO2) ratio ≤ 300 mmHg
2. Currently on 1 or more continuous vasopressor infusion which were started at least 4 hours ago at a minimum dose of :
1. Dopamine greater than 5 mcg/kg/min
2. Noradrenaline ≥ 0.1mcg/kg/min
3. Adrenaline ≥ 0.1 mcg/kg/min
4. Any dose of total vasopressin
5. Milrinone \>0.25mcg/kg/min)
3. Renal dysfunction defined as
In patients without known renal disease:
1. serum creatinine \> 171 mmol/l OR
2. Currently receiving renal replacement therapy
In patients with known renal disease:
3. an absolute increase of \> 50% in creatinine from baseline OR
4. Currently receiving renal replacement therapy
4. Currently has an intracranial pressure monitor or ventricular drain in situ
5. Currently receiving extracorporeal membrane oxygenation
6. Currently has a ventricular assist device
Exclusion Criteria:
* Both EN and PN cannot be delivered at enrollment (i.e. either an enteral tube or a central venous catheter cannot be placed or clinicians feel that EN or PN cannot be safely administered due to any other reason).
* Currently receiving PN
* Standard PN solutions cannot be delivered at enrolment (i.e. clinicians believe that a patient definitely needs a specific parenteral nutrition formulation (e.g. glutamine-supplementation or specific lipid formulation).
* Death is imminent or deemed highly likely in the next 96 hours.
* There is a current treatment limitation in place or the patient is unlikely to survive to 6 months due to underlying illness
* More than 80% of energy requirements have been satisfactorily delivered via the enteral route in the last 24 hours.
* Are known to be pregnant
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Study:
NCT01847534
Study Brief:
Protocol Section:
NCT01847534