PEP uP Protocol in Surgical Patients
Stopped early · Phase 4
Conditions studied: Critically Ill
In brief
The main objective of this project is to asses for safety, feasibility and effectiveness of an aggressive feeding protocol, PEP uP (Enhanced Protein-Energy Provision via the Enteral Route Feeding Protocol) in increasing protein and energy delivery to critically ill surgical patients. Our hypothesis is that an aggressive feeding protocol, PEP uP will be safe, acceptable, and effectively increase protein and energy delivery to critically ill surgical patients.
Key facts
- Study ID
- NCT02459275
- Run by
- Clinical Evaluation Research Unit at Kingston General Hospital
- People needed
- 36
- Starts
- 2015-07-01
- Expected to finish
- 2017-09-01
- Last updated by the study team
- 2020-10-27
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age ≥ 18 years
- ICU admission within past 48 hours
- Initiation of tube feeds currently planned by the surgical ICU (SICU) team and primary surgical team
- Admitted by a surgical service to the SICU (not a medical ICU or neurology patient)
- Expected to remain mechanically ventilated for > 24 h and expected to require ICU care for > 72 h after screening
You may not qualify if…
- Pregnancy
- Attending surgeon preference (they must agree to feeding their patient according to the protocol in either arm using the goal rate determined by the SICU team and the nutritionist)
- Contraindication to enteral nutrition (bowel obstruction, bowel discontinuity, proximal enterocutaneous fistula, and short gut syndrome)
- Do not resuscitate (DNR) status or goals of care that specify limitations in medical therapies
- Death expected within 24 hours
Where it is running
- Massachusetts General Hospital — Boston, Massachusetts, United States
- Brigham and Women's Hospital — Boston, Massachusetts, United States
- Jamaica Hospital Medical Center — Jamaica, New York, United States
- Virginia Tech Carilion School of Medicine — Roanoke, Virginia, United States
Full record on ClinicalTrials.gov
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