When a person's stomach doesn't empty properly, which delivers more feed, feeding into the stomach with the help of drugs to help emptying or feeding directly into the intestine?
- Conditions
- Delayed gastric emptying, refractory to 24h of metoclopramide treatment in mechanically ventilated patients.MedDRA version: 14.1Level: LLTClassification code 10012199Term: Delayed gastric emptyingSystem Organ Class: 100000004856Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
- Registration Number
- EUCTR2012-001374-29-GB
- Lead Sponsor
- orth Bristol NHS Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
1. Mechanically ventilated.
2. Poor gastric emptying defined as 1 or more gastric residual volumes >=250mL in 24h after 3 x 10mg doses of IV metoclopramide in the last 24h.
3. Enteral feeding possible and likely to be required >72h.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50
Exclusion Criteria
1. Moribund or limited active treatment.
2. Enteral nutrition contraindicated (eg. ileus) or limited to less than full requirements (eg. short bowel syndrome).
3. Contraindication to placement of a naso- or oro-intestinal tube (eg. no safe GI access).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: When a person's stomach is not emptying feed properly into the small intestine, which treatment increases the volume of feed delivered and retained (ie. not discarded or vomited):<br>1. Feeding into the stomach and using drugs to help the stomach empty feed into the small intestine or<br>2. Feeding directly into the small intestine.;Secondary Objective: To evaluate whether to conduct a larger trial, comparing intestinal feeding versus stomach feeding plus prokinetic drugs to determine whether:<br>1. Treatments are safe and feasible.<br>2. Protocols work and recruitment rates are sufficient.;Primary end point(s): Percentage of goal feed rate.;Timepoint(s) of evaluation of this end point: days 1-2.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): % success of intestinal tube placement;Timepoint(s) of evaluation of this end point: Duration of nasointestinal feeding; normally day 1-5.