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:
2025-12-24 @ 3:40 PM
Ignite Modification Date:
2025-12-24 @ 3:40 PM
NCT ID:
NCT01934192
Eligibility Criteria:
Inclusion Criteria:
* Age \& Gender: Male or female between 18 and 85 years of age inclusive, at the time of obtaining the informed consent.
* First admitted to participating ICU within the previous 48 hours.
* Intubated and invasively mechanically ventilated
* Indicated to receive early EN or are already receiving EN (subject must be on EN prior to receiving study treatment)
* Have at least one of the following
* Clinical evidence of cardiovascular dysfunction defined as the need for vasopressor agents (e.g. norepinephrine, epinephrine, vasopressin), \>5 microgram/kg/min of dopamine, or \>/= 50 microgram/min phenylephrine) for greater than or equal to 2 hours;
* Poly-trauma with an injury severity score (ISS) \>=15 points
* Acute traumatic or non-traumatic brain injury Glasgow Coma Scale (GCS) \<=12, prior to the initiation of sedation.
Exclusion Criteria:
* Subjects who are not expected to be in the ICU and alive for at least 48 hrs from point of screening.
* Subjects with acute hepatitis (e.g. acute hepatitis B or C) or severe chronic liver disease (e.g. Child Pugh class C cirrhosis) will be excluded
* Liver function tests: If Alanine aminotransferase (ALT) \>=8x upper limit of normal (ULN); OR If ALT \>5-8x ULN and bilirubin \>2\<=3 ULN or bilirubin \>3x ULN (Include only if bilirubin \<1.5xULN); OR If ALT \<=5xULN and Bilirubin \>3xULN (Include only if ALT \<=3xULN and Bilirubin \>2 \<=3xULN)
* Subjects who have received a gastric prokinetic agent in the previous 12 hours (e.g., erythromycin, azithromycin, metoclopramide, domperidone).
* QT duration corrected for heart rate (QTc) \>480 ms. QTcF is the recommended correction factor for all sites. If QT duration corrected for heart rate by Fridericia's formula (QTcF) is not possible to obtain or calculate, QT duration corrected for heart rate by Bazett's formula (QTcB) or machine or manual over read, may be obtained after consultation with the medical monitor. The QT correction formula used to determine inclusion and discontinuation should be the same throughout the study.
* Use of strong Cyp3A4 inhibitors
* Subjects who require renal replacement therapy or with an estimated glomerular filtration rate (GFR) of \<30 mL/min byCockroft-Gault calculation).
* Subjects who have a history of or who have undergone major esophageal or gastric surgery on this admission (major lower abdominal surgery will not result in exclusion unless this carries a contraindication to enteral feeding).
* Subjects with an absolute contraindication to enteral nutrition e.g. subjects with ongoing bowel obstruction or perforation.
* Subject has a gastric pacemaker
* Pregnant or lactating females
* History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation.
* Concurrent enrollment in other interventional study involving a novel (i.e.unapproved or experimental) chemical or biopharmaceutical entity.
* Previous randomization in this study
* Subjects for whom the reason for admission to ICU was an overdose (deliberate or accidental; medicinal product or not).
* Exclusion to re-randomization:
* Subjects with an untreated pheochromocytoma.
* Subjects with a past history of a seizure disorder (e.g., epilepsy) and is currently receiving anti-epileptic treatment for their seizure disorder, ongoing refractory, or sustained seizure disorder (prophylactic use for head injury/isolated new seizure maintained on anti-seizure meds in ICU acceptable).
* Subjects taking drugs likely to cause extrapyramidal reactions.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT01934192
Study Brief:
Protocol Section:
NCT01934192