PEP uP Protocol in Surgical Patients

NCT02459275 | Terminated Phase 4 Results DMC FDA Drug

• 1 other identifier: PEP uP Surgical RCT
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Critically Ill

Keywords

feeding protocol; enteral nutrition protocol; critically ill; surgical ICU; enteral nutrition; nutrition therapy

Outcome Measures

Primary Outcomes (2)

• Total Amount of Protein Received

  The total amount of protein received from either EN or parenteral nutrition (PN), inclusive of propofol, divided by the amount prescribed as per the baseline assessment and expressed as a percentage.

  12 days

• Total Amount of Energy

  The total amount of energy received from either EN or parenteral nutrition (PN), inclusive of propofol, divided by the amount prescribed as per the baseline assessment and expressed as a percentage.

  12 days

Secondary Outcomes (4)

• Time to Initiation of Enteral Nutrition

  12 days

• ICU Length of Stay

  up to 60 days

• Mortality

  up to 60 days

• Hospital Length of Stay

  up to 60 days

Study Arms (2)

PEP uP Protocol

EXPERIMENTAL

Participants will receive the PEP uP protocol with the pro motility agent. The intervention will be provided until the tube feeds are stopped or patient is fed meals orally and will be tracked until hospital discharge or 60 days which ever occur first.

Other: PEP uP Protocol; Drug: Metoclopramide

Standard of Care

NO INTERVENTION

Standard formula polymeric tube feeds started at a rate of 20 ml/hour. Gastric residual volume (GRV) will be checked every 4 hours. GRV is reinfused to the patient each time it is checked. GRV threshold is 200-500 ml. If the patient is tolerating tube feeds as determined by measuring the GRV, the rate is advanced by 20 ml/hour every 4 hours up to the goal rate. Participants will be followed until the tube feeds are stopped or patient is fed meals orally and will be tracked until hospital discharge or 60 days which ever occur first.

Interventions

PEP uP Protocol OTHER

Semi-elemental tube feeds are started at the hourly goal rate as determined by the 24 hour volume goal. Protein supplements will be started at the initiation of tube feeds to target a daily delivery of 2 g/kg/day.

PEP uP Protocol

Metoclopramide DRUG

Metoclopramide 10mg Intravenous (IV) every 6 hours (q6h) or 5mg IV q6h for renal failure will be started empirically concomitant with EN initiation. Gastric Residual Volume (GRV) will be checked every 4 hours and will be reinfused to the patient each time it is checked.

Also known as: Reglan

PEP uP Protocol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Clinical Evaluation Research Unit at Kingston General Hospital: lead
• Nestle Health Science: collaborator

Study Sites (4)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Jamaica Hospital Medical Center

Jamaica, New York, 11418, United States

Location

Virginia Tech Carilion School of Medicine

Roanoke, Virginia, 24016, United States

Location

Related Publications (4)

• 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.

  PMID: 20429886 BACKGROUND

• Heyland DK, Murch L, Cahill N, McCall M, Muscedere J, Stelfox HT, Bray T, Tanguay T, Jiang X, Day AG. Enhanced protein-energy provision via the enteral route feeding protocol in critically ill patients: results of a cluster randomized trial. Crit Care Med. 2013 Dec;41(12):2743-53. doi: 10.1097/CCM.0b013e31829efef5.

  PMID: 23982032 BACKGROUND

• 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. Epub 2014 Apr 18.

  PMID: 24748597 BACKGROUND

• McCall M, Cahill N, Murch L, Sinuff T, Bray T, Tanguay T, Heyland DK. Lessons Learned From Implementing a Novel Feeding Protocol: Results of a Multicenter Evaluation of Educational Strategies. Nutr Clin Pract. 2014 Aug;29(4):510-517. doi: 10.1177/0884533614531047. Epub 2014 Apr 22.

  PMID: 24757062 BACKGROUND

Related Links

• Critical Care Nutrition website including information on the PEP uP Protocol

MeSH Terms

Conditions

Critical Illness

Interventions

Metoclopramide

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; para-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Chlorobenzoates; Hydroxybenzoate Ethers; Hydroxybenzoates; Hydroxy Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenyl Ethers; Phenols

Results Point of Contact

• Title: Dr. D. Dante Yeh
• Organization: University of Miami

dxy154@med.miami.edu

305-585-1822

Study Officials

• Daren K Heyland, MD

  Clinical Evaluation Research Unit

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Daniel Dante Yeh, MD

Study Record Dates

• First Submitted: May 27, 2015
• First Posted: June 2, 2015
• Study Start: July 1, 2015
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: October 27, 2020
• Results First Posted: October 27, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)