The Energy Dose Study

Phase 2 Terminated 12 enrolled Emory University National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · collab

RandomizedParallel-groupTriple-blindSupportive care

Summary

The investigators have designed this single-center Randomized Clinical Trial (RCT) to prospectively compare, for the first time, the clinical efficacy of different energy doses in intensive care unit (ICU) patients requiring parenteral nutrition (PN) due to intestinal failure/dysfunction. This study intends to enroll a total of 60 patients (20 per energy dose group) to generate critical preliminary data needed to inform subsequent appropriately powered Phase III multicenter trials.

Timeline

Start: 2011-07
Primary completion: 2014-12-02
Completion: 2014-12-02

Outcome

Outcome not reported

Stopped (Enrollment): “This study was halted pending additional funding and ultimately was terminated due to difficulties with ongoing recruitment, etc.”

Drugs

Evaluation	Drug	Modality	Dose	Route
Background	Clevidipine	Small molecule	—	—
Background	Propofol	Small molecule	—	—

Indications

No indication recorded.