Critically IllprokineticsNCT00916591
Prokinetic Drugs and Enteral Nutrition
An observational study of Critically Ill and Enteral Nutrition, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
Trial summary
The purpose of this study is to compare the effect of two drugs that can help in the prevention of regurgitation during the administration of enteral nutrition and define which one is the most effective. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critically Ill, Enteral Nutrition
- How many people
- 60 participants
- Where
- 1 siteBelgium
- Study dates
- Sep 2009to not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Critically ill patients, intubated and mechanically ventilated, 18 years or older
Who may be able to join
- critically ill patients
- intubated
- mechanically ventilated
- 18 or older age
- enterally fed
Who cannot join
- prokinetic drugs before start study
- allergy to study medication
- interactions odf study medication with other drugs
- recent gastro-intestinal surgery
- history of esophagectomy or gastrectomy
- suspicion of gastrointestinal perforation
Show all 10Show fewer
- myasthenia gravis
- liver dysfunction
- less than 7 days in study
- gastro- or jejunostomy
Trial locations and contacts
1 site in 1 country.
Belgium1 site
UZBrussels
Jette, 1090
Nele Van De Winkel, MD, 00324773348, nelevandewinkel@hotmail.com
Nele Van De Winkel, MD
About this study
Official title: Effect of Prokinetic Drugs During the Administration of Enteral Nutrition
The purpose of this study is to compare the effect of two drugs that can help in the prevention of regurgitation during the administration of enteral nutrition and define which one is the most effective.
Read the detailed description
Two prokinetic drugs (metoclopramide and erythromycin) will be compared during the administration of enteral nutrition in critically ill patients. We would like to know which one is the most effective in preventing regurgitation and risk of aspiration, which is a common complication of enteral nutritional support. This will be evaluated by measuring gastric residue every six hours.
- Conditions
- Critically Ill, Enteral Nutrition
- Keywords
- gastroesophageal reflux, respiratory aspiration
- Medical subject headings
- Critical Illness, Gastroesophageal Reflux, Respiratory Aspiration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2009 (estimated)
- Study startSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critically IllStudies of the same condition, open and under way.
- More trials run by Universitair Ziekenhuis BrusselThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00916591
- Sponsor's protocol ID
- UZBrussels
- Other IDs
- 2009-012342-23, 2009
- Acronym
- prokinetics
- Status last verified
- Jun 2009
- First submitted
- 5 Jun 2009
- Last updated
- 9 Jun 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Prokinetic Drugs During the Administration of Enteral Nutrition
- ClinicalTrials.gov ID
- NCT00916591
- Acronym / sponsor ID
- prokinetics / UZBrussels
- Conditions
- Critically Ill, Enteral Nutrition
- Keywords
- gastroesophageal reflux, respiratory aspiration
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Study start
- Sep 2009
- First posted
- 9 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare the effect of two drugs that can help in the prevention of regurgitation during the administration of enteral nutrition and define which one is the most effective.
Detailed description
Two prokinetic drugs (metoclopramide and erythromycin) will be compared during the administration of enteral nutrition in critically ill patients. We would like to know which one is the most effective in preventing regurgitation and risk of aspiration, which is a common complication of enteral nutritional support. This will be evaluated by measuring gastric residue every six hours.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Critically ill patients, intubated and mechanically ventilated, 18 years or older
Key inclusion criteria (5 listed)
- critically ill patients
- intubated
- mechanically ventilated
- 18 or older age
- enterally fed
Key exclusion criteria (10 listed)
- prokinetic drugs before start study
- allergy to study medication
- interactions odf study medication with other drugs
- recent gastro-intestinal surgery
- history of esophagectomy or gastrectomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critically Ill and Enteral Nutrition, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nele Van De Winkel (00324773348, nelevandewinkel@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2009; AzTrials last refreshed its copy on 7 Nov 2026.