Critically Ill Clinical Trial
— PEPuPOfficial title:
A Multicenter, Cluster Randomized Trial of Enhanced Protein-Energy Provision Via the Enteral Route Feeding Protocol in Critically Ill Patients: The PEP uP Protocol
NCT number | NCT01167595 |
Other study ID # | PEPuP cRCT |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | September 2010 |
Est. completion date | November 2011 |
Verified date | April 2021 |
Source | Clinical Evaluation Research Unit at Kingston General Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Critically ill patients are consistently underfed. Feeding protocols are standardized system tools used to guide nutrition practices, but to date have failed to improve delivery of nutrition. The PEP uP Protocol is a new enhanced feeding protocol. Twenty North American Intensive Care Units (ICUs) will assess baseline nutrition practices. Ten ICUs will be randomized to implement the PEP uP Protocol and educational intervention, and ten will be randomized to continue usual care. Nutrition practices will be reevaluated 6 months after baseline. The investigators hypothesize that the PEP uP Protocol will increase delivery of nutrition, and may ultimately lead to improved survival of critical illness.
Status | Completed |
Enrollment | 1059 |
Est. completion date | November 2011 |
Est. primary completion date | November 2011 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Critically ill adults (i.e. >18 years of age) - Mechanically ventilated before or within the first 6 hours of admission to ICU Exclusion Criteria: - Nutrition (either EN or Parenteral Nutrition (PN)) started before admission to ICU - Not intubated within 6 hours of admission to ICU - Receiving non-invasive ventilation (i.e. mask ventilation) during the first 6 hours of ICU stay - Moribund (as evidenced by death within 48 hours of admission to ICU) |
Country | Name | City | State |
---|---|---|---|
Canada | Rouge Valley Health System - Ajax and Pickering Site | Ajax | Ontario |
Canada | William Osler Health Centre - Brampton Civic Campus | Brampton | Ontario |
Canada | Foothills Medical Centre | Calgary | Alberta |
Canada | William Osler Health Centre - Etobicoke Campus | Etobicoke | Ontario |
Canada | St Joseph's Healthcare | Hamilton | Ontario |
Canada | The Credit Valley Hospital | Mississauga | Ontario |
Canada | Pasqua Hospital | Regina | Saskatchewan |
Canada | Rouge Valley Health System - Centenary Site | Scarborough | Ontario |
Canada | St Paul's Hospital | Vancouver | British Columbia |
United States | Henry Ford Macomb Hospital | Clinton Township | Michigan |
United States | Nassau University Medical Center | East Meadow | New York |
United States | Lakes Region General Hospital | Laconia | New Hampshire |
United States | Medical Center of the Rockies | Loveland | Colorado |
United States | Phoenix Veterans Affairs Health Care System | Phoenix | Arizona |
United States | Vassar Brothers Medical Center | Poughkeepsie | New York |
United States | South Texas Veterans Health Care System Audie L. Murphy Division | San Antonio | Texas |
United States | CoxHealth | Springfield | Missouri |
United States | Washington Health Center | Washington | District of Columbia |
Lead Sponsor | Collaborator |
---|---|
Clinical Evaluation Research Unit at Kingston General Hospital | Nestlé |
United States, Canada,
Heyland DK, Cahill NE, Dhaliwal R, Wang M, Day AG, Alenzi A, Aris F, Muscedere J, Drover JW, McClave SA. Enhanced protein-energy provision via the enteral route in critically ill patients: a single center feasibility trial of the PEP uP protocol. Crit Care. 2010;14(2):R78. doi: 10.1186/cc8991. Epub 2010 Apr 29. — View Citation
Heyland DK, Dhaliwal R, Lemieux M, Wang M, Day AG. Implementing the PEP uP Protocol in Critical Care Units in Canada: Results of a Multicenter, Quality Improvement Study. JPEN J Parenter Enteral Nutr. 2015 Aug;39(6):698-706. doi: 10.1177/0148607114531787. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of Prescribed Calories From Energy | Total calories received from enteral nutrition/total prescription up to 12 evaluable ICU days | first 12 days | |
Primary | Percentage of Prescribed Protein | Total protein received from enteral nutrition/total prescription up to 12 evaluable ICU days | first 12 days | |
Secondary | Timeliness of Initiation of EN | Time of the initiation of EN from ICU admit | 60 days | |
Secondary | Percentage of Participants With Vomiting | 60 days | ||
Secondary | Percentage of Participants With Pneumonia | 60 days |
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