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Dietary Supplement

Early Tube Feeding After Gastrostomy Surgery (PEG Trial)

N/A

Recruiting

Led By Katie L Bower, MD

Research Sponsored by Carilion Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Negative pregnancy test for women participants of child-bearing age

Tolerating tube feeds at goal prior to procedure

Must not have

Clinical contraindications for PEG tube placement

Patients with feeding intolerance prior to PEG tube procedure

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 hours before to 72 hours after the procedure

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing when to start feeding patients through a PEG tube after surgery, to see what works best.

Who is the study for?

This trial is for adults over 18 who are on mechanical ventilation in the ICU due to trauma or surgery and need a PEG tube for feeding. They must have been tolerating tube feeds before the procedure. It's not for those with gut motility issues, feed intolerance, abnormal GI anatomy, or if the PEG isn't placed at an ICU bedside.

What is being tested?

The study tests whether starting tube feeding within one hour after placing a PEG (feeding) tube is beneficial for ventilated patients in surgical and trauma ICUs. This randomized controlled trial aims to find the best timing for enteral nutrition under these conditions.

What are the potential side effects?

Since this trial involves early feeding through a PEG tube, potential side effects may include abdominal discomfort, bloating, diarrhea, aspiration pneumonia or complications related to the PEG placement like infection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am not pregnant.

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I am managing my tube feeds well before the procedure.

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I am on a ventilator and need a tube placed in my stomach for feeding due to surgery or injury.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot have a PEG tube placed due to health reasons.

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I have had trouble eating before getting a feeding tube.

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I have a disorder that affects how food moves through my stomach and intestines.

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My feeding tube placement was not done in the ICU.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 hours before to 72 hours after the procedure

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 hours before to 72 hours after the procedure

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 hours before to 72 hours after the procedure for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Hours fasted

Secondary study objectives

Calorie deficit

Complications

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: FAST: Start tube feeds 4 hours after procedureActive Control1 Intervention

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.

Group II: noFast: Start tube feeds within 1 hour of procedureActive Control1 Intervention

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.

0 / 7Eligibility criteria met