Nutritional Adequacy Therapeutic Enhancement in the Critically Ill. The NUTRIATE Study
Status:
Terminated
Trial end date:
2016-07-08
Target enrollment:
Participant gender:
Summary
This is a multi-center, parallel group, placebo-controlled and active-compared, randomized
study to assess the ability of GSK962040 to enhance the delivery of enteral feed to
critically ill subjects that are predisposed to developing feeding intolerance (e.g.,
percentage of goal volume); enhance gastric emptying in this population; and provide
preliminary evidence of the drug's effect on outcomes of therapy (length of stay in the
Intensive Care Unit [ICU], time on ventilator, ICU acquired infections, and 60-day
mortality). Other aims are evaluation of GSK962040 safety, tolerability and pharmacokinetics
upon repeat dosing in a critically ill population.
After meeting eligibility criteria, male and female subjects will be randomized to either
receive GSK962040 (50 milligram [mg]) once daily (OD) via naso-gastric (NG) or orogastric
(OG) feeding tube (oral solution), or placebo by the same route. If subjects develop
intolerance to enteral feeding at any point up to Dose 5 of study medication (inclusive),
study treatments will switch such that those originally receiving GSK962040 will receive
metoclopramide (10 mg, intravenous [iv], every 6 hours) and those subjects originally
randomized to receive placebo will receive GSK962040 (50 mg, via NG, OD). Additionally, if
subjects develop intolerance prior to any treatment, they will be randomized to receive
either GSK962040 (50 mg, via NG, OD) or metoclopramide (10 mg, iv, every 6 hours).
The study will consist of a screening/baseline assessment, a treatment period (up to 7 days
in duration), and a 4-day post treatment safety follow-up assessment. The duration of each
subject's participation in the study from screening to follow-up safety assessment will be up
to approximately 2 weeks. In addition, mortality will be assessed 60 days after admission to
the ICU.