TAK-954 in Critically Ill Participants With Enteral Feeding Intolerance (EFI)

Stopped early · Phase 2

Conditions studied: Critical Illness, Enteral Nutrition, Enteral Feeding Intolerance

In brief

The purpose of this study is to assess the treatment effect of intravenous TAK-954 in improving the average daily protein adequacy received through enteral nutrition in critically-ill participants developing EFI.

Key facts

Study ID

NCT03477903

Run by

Millennium Pharmaceuticals, Inc.

People needed

1

Starts

2018-08-25

Expected to finish

2018-08-29

Last updated by the study team

2019-09-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Has at least a size 12-(french size) Fr nasogastric or orogastric tube with its tip at least 10 centimeter (cm) below the esophagogastric junction confirmed radiologically (the tip of the tube must be in the body or the antrum of the stomach and not in the fundus).
• Is intubated and mechanically ventilated in the ICU.
• Is expected to remain alive, mechanically ventilated, and receive continuous enteral feeding for >=48 hours following randomization.
• Have EFI, defined as a single GRV measurement of >=250 mL with vomiting/retching within the last 24 hours, or a single GRV measurement of >=500 mL with or without vomiting/retching within the last 24 hours.

You may not qualify if…

• Is under consideration for withdrawal of life-sustaining treatments within the next 72 hours.
• Has had major esophageal or gastric surgery or direct luminal trauma on this admission (participants with lower abdominal surgery are not excluded unless enteral feeding is contraindicated).
• Has mechanical bowel obstruction, short bowel syndrome, or the presence of an active gastric pacemaker.
• Have pre-existing hepatic disease that meets Child-Pugh Class B (moderate; total score 7 to 9 points) or C (severe; total score 10 to 15 points).
• Has been admitted primarily for treatment of a drug overdose.
• Has a presence of a post-pyloric tube in place at Randomization that may be used for enteral nutrition.
• Is receiving parenteral nutrition (PN) at Screening.
• Is in diabetic ketoacidosis or non-ketotic hyperosmolar coma.
• Has a different nutrient requirement than allowed in feeding protocol.(outside a range of 1.2 to 2 gram per kilogram per day [g/kg/day] of proteins and up to 1.5 kilocalorie per milliliter [kcal/mL]).

Where it is running

• Joseph M Still Burn Centers — Augusta, Georgia, United States
• Eastern Idaho Medical Consultants — Idaho Falls, Idaho, United States
• Illinois Lung & Critical Care Institute — Peoria, Illinois, United States
• University of Kentucky Health Care — Lexington, Kentucky, United States
• Anne Arundel Medical Center — Annapolis, Maryland, United States
• Truman Medical Center Hospital Hill — Kansas City, Missouri, United States
• Creighton University — Omaha, Nebraska, United States
• Englewood Hospital and Medical Center — Englewood, New Jersey, United States
• New York-Presbyterian Columbia University Medical Center — New York, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma, United States
• The University of Texas Health Science Center at Houston — Houston, Texas, United States
• Froedtert Hospital — Wauwatosa, Wisconsin, United States
• Royal North Shore Hospital — St Leonards, New South Wales, Australia
• Royal Brisbane and Women's Hospital — Brisbane, Queensland, Australia
• Logan Hospital — Meadowbrook, Queensland, Australia
• Mater Hospital Brisbane — South Brisbane, Queensland, Australia
• Royal Adelaide Hospital — Adelaide, South Australia, Australia
• Flinders Medical Centre — Bedford Park, South Australia, Australia
• Monash Medical Centre — Clayton, Victoria, Australia
• The Northern Hospital — Epping, Victoria, Australia
• Frankston Hospital — Frankston, Victoria, Australia
• The Royal Melbourne Hospital — Parkville, Victoria, Australia
• Royal Columbian Hospital — New Westminster, British Columbia, Canada

Full record on ClinicalTrials.gov

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