Recruiting

Early Feeding

Sponsor:

Carilion Clinic

Code:

NCT04110613

Conditions

Critical Illness

Malnutrition

Gastrostomy

Procedural Sequelae

Trauma

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

noFast: Start tube feeds within 1 hour of procedure

Study Details

Brief summary:

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.

Conditions

Critical Illness

Malnutrition

Gastrostomy

Procedural Sequelae

Trauma

Study ID

NCT04110613

Start date

Sep 19, 2019

Status verified date

Oct, 2021

Completion date

Sep 30, 2026

Anticipated

Primary completion date

Sep 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Adult subjects over 18 years of age
  • Negative pregnancy test for women participants of child-bearing age
  • Mechanically ventilated surgical and trauma patients with clinical indication for PEG tube placement
  • Tolerating tube feeds at goal prior to procedure

Exclusion Criteria:

  • Patients with aberant gastrointestinal anatomy
  • Patients with gastrointestinal motility disorders
  • Patients with feeding intolerance prior to PEG tube procedure
  • Pregnant women, children, or other vulnerable populations
  • Clinical contraindications for PEG tube placement
  • PEG performed in setting other than ICU at bedside

Study Design

Enrollment

1200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

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.

Interventions

noFast: Start tube feeds within 1 hour of procedure

Earliest possible initiation of tube feeding after bedside PEG tube procedure.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Katie L. Bower, MD

540-981-7434klbower@vt.edu

Jordan Darden, PhD

540-529-7792jadarden@carilionclinic.org

Locations

Carilion Roanoke Memorial Hospital

Recruiting

Roanoke, Virginia, United States, 24014

Contacts

Michelle Rothrock

540-985-8510mlrothrock@carilionclinic.org

Jordan Darden, PhD

540-529-7792jadarden@carilionclinic.org

More Information

Sponsor

Carilion Clinic

Last update posted

Oct 26, 2021

Last verified

Oct, 2021

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Carilion Clinic on 2021-10-26.