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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?

Delivering adequate nutrition to critically ill patients suffering delayed gastric emptying: RCT of nasointestinal feeding versus nasogastric feeding plus prokinetics. - Nasointestinal versus nasogastric feeding plus prokinetics

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2012-001374-29-GB
Enrollment
Unknown
Registered
2012-10-16
Start date
2012-11-30
Completion date
Unknown
Last updated
2015-08-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Delayed gastric emptying, refractory to 24h of metoclopramide treatment in mechanically ventilated patients. MedDRA version: 14.1 Level: LLT Classification code 10012199 Term: Delayed gastric emptying System Organ Class: 100000004856

Interventions

Trade Name: Erythromycin Product Name: metoclopramide Pharmaceutical Form: Injection INN or Proposed INN: metoclopramide CAS Number: 7232-21-5 Current Sponsor code: n/a Other descriptive name: maxolon

Sponsors

North Bristol NHS Trust
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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).

Design outcomes

Primary

MeasureTime frame
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): 1. Feeding into the stomach and using drugs to help the stomach empty feed into the small intestine or 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: 1. Treatments are safe and feasible. 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

MeasureTime frame
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.—

Countries

United Kingdom

Contacts

Public ContactTaylor

Stephen

stephen.taylor@nbt.nhs.uk01173406581

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026