RCT: Early Feeding After PEG Placement

Part of paid clinical trials in Roanoke, Virginia.

Sponsor
Carilion Clinic
Study ID
NCT04110613
Status
Recruiting
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Conditions

  • Critical Illness
  • Gastrostomy
  • Malnutrition
  • Mechanical Ventilation
  • Procedural Sequelae
  • Surgery
  • Trauma

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • noFast: Start tube feeds within 1 hour of procedure — DIETARY_SUPPLEMENT
    Earliest possible initiation of tube feeding after bedside PEG tube procedure.

Study Details

Randomized controlled trial to establish evidence on which to base timing of enteral feeding after bedside PEG placement in ventilated Trauma and Surgical ICU patients.

Key Dates

Start date
Sep 19, 2019
Status verified
Oct 2021
Primary completion
Sep 30, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
1,200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Active Comparator: noFast: Start tube feeds within 1 hour of procedure
    The noFAST group will have post-PEG tube feeds initiated \<1 hour after the procedure. Feeds are to be initiated at the rate and with the formula the patient was tolerating prior to the procedure.
  • No Intervention: FAST: Start tube feeds 4 hours after procedure
    The FAST group will have post-PEG tube feeds initiated 4 hours after the procedure. Feeds are to be initiated at the rate and with the formula the patient was tolerating prior to the procedure.

Primary Outcome Measure

Hours fasted [ Time Frame: 24 hours before to 72 hours after the procedure ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Carilion Roanoke Memorial HospitalRoanokeVirginia24014
Michelle Rothrock
[email protected]
540-985-8510
Jordan Darden, PhD
[email protected]
540-529-7792

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By research site
Carilion Roanoke Memorial Hospital· Roanoke, VA

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