Gastrointestinal HemorrhageNCT01477320
Enteral Nutrition as Stress Ulcer Prophylaxis in Critically Ill Patients.
A study testing Pantoprazole 40 mg IV daily and tube feed. in people with Gastrointestinal Hemorrhage and Clostridium Difficile Colitis, run by Mohamed Saad at 1 site in United States.
Trial summary
study is to determine if proton pump inhibitors plus enteral nutrition is superior to enteral nutrition alone as a stress ulcer prophylaxis strategy in critically ill patients in terms of incidence of overt and significant GI bleeding related to stress gastropathy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrointestinal Hemorrhage, Clostridium Difficile Colitis
- What is being tested?
- Pantoprazole 40 mg IV daily and tube feed.
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 124 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to Jul 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- Age 18 years or older
- Admission to the medical ICU at University of Louisville Hospital or Jewish Hospital
- Expected need for mechanical ventilation > 48 hours
- No contraindication to EN within the first 24 hours after admission to the ICU
Who cannot join
- Evidence of active GI bleeding during current hospitalization prior to study entry
- Admission to ICU with primary diagnosis of burn injury
- Closed head injury or increased intracranial pressure
- Partial or complete gastrectomy
- Pregnancy or lactation
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Louisville hospital
Louisville, Kentucky, 40202
About this study
Official title: Enteral Nutrition as Stress Ulcer Prophylaxis in Critically Ill Patients. Prospective, Double-blind, Randomized, Placebo-controlled Study.
study is to determine if proton pump inhibitors plus enteral nutrition is superior to enteral nutrition alone as a stress ulcer prophylaxis strategy in critically ill patients in terms of incidence of overt and significant GI bleeding related to stress gastropathy.
- Being tested
- Pantoprazole 40 mg IV daily and tube feed., Placebo and tube feed
- Keywords
- Enteral Nutrition, Stress Ulcer Prophylaxis, Critically Ill Patients, Overt and significant GI bleeding, Stress gastropathy, Clostridium Difficile pseudomembranous colitis, Vital AF, Small peptide fish oil structured lipids, Fructose oligosaccharide
- Medical subject headings
- Gastrointestinal Hemorrhage, Enterocolitis, Pseudomembranous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pantoprazole 40 mg IV daily and tube feed.Drug
Also called Tube feed formula:(Vital AF "Advanced Formula" 1.2 Cal(TM),Abbott,Columbus,OH)
Patients randomized to the control group "active Comparator" will receive tube feed plus an Pantoprazole 40 mg IV daily.
Placebo and tube feedOther
Also called Tube feed formula:(Vital AF "Advanced Formula" 1.2 Cal(TM),Abbott,Columbus,OH)
Patients randomized to Placebo group "placebo Comparator" will receive tube feed plus an Placebo.
| Study group | Role | What they receive |
|---|---|---|
| Pantoprazole 40mg IV daily and tube feed | Active comparator | Not described Receives: Drug: Pantoprazole 40 mg IV daily and tube feed. |
| Placebo and tube feed. | Placebo comparator | Not described Receives: Other: Placebo and tube feed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects With GI Bleeding
- Incidence of overt GI bleeding (as defined by the presence of coffee ground emesis, hematemesis of bright red blood, melena, or hematochezia) seen with Proton Pump Inhibitor (PPI) and EN versus EN alone in critically ill patients.
- Incidence of significant GI bleeding, defined by a 3-point decrease in hematocrit within 24 hours accompanied by signs of overt GI bleeding, or by an unexplained 6-point decrease in hematocrit during any 48 hour period.
Measured: Subjects will be followed from date of randomization until discharge from the ICU or cessation of Enteral Nutrition (EN) and successful initiation of oral feeds up to 100 weeks.
Secondary outcomes (1)
Number of Subjects With ICU-acquired C. Difficile Pseudomembranous Colitis.
Measured: Subjects will be followed until discharge from the ICU or cessation of EN and successful initiation of oral feeds up to 100 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2011 (estimated)
- Study startSep 2013
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Gastrointestinal HemorrhageStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mohamed Saad
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott Nutrition, University of Louisville
- Responsible party
- Sponsor-investigator, Mohamed Saad, University of Louisville
- Investigators
- Mohamed Saad, MD, Principal investigator, University of Louisville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01477320
- Sponsor's protocol ID
- 11.0170
- Status last verified
- Dec 2017
- First submitted
- 4 Oct 2011
- Last updated
- 16 Jan 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enteral Nutrition as Stress Ulcer Prophylaxis in Critically Ill Patients. Prospective, Double-blind, Randomized, Placebo-controlled Study.
- ClinicalTrials.gov ID
- NCT01477320
- Acronym / sponsor ID
- 11.0170
- Keywords
- Enteral Nutrition, Stress Ulcer Prophylaxis, Critically Ill Patients, Overt and significant GI bleeding, Stress gastropathy, Clostridium Difficile pseudomembranous colitis, Vital AF, Small peptide fish oil structured lipids
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Mohamed SaadUniversity, hospital or other
- Collaborators
- Abbott Nutrition, University of Louisville
- Study start
- Sep 2013
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 22 Nov 2011 (estimated)
- Results
- Posted 16 Jan 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
study is to determine if proton pump inhibitors plus enteral nutrition is superior to enteral nutrition alone as a stress ulcer prophylaxis strategy in critically ill patients in terms of incidence of overt and significant GI bleeding related to stress gastropathy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pantoprazole 40mg IV daily and tube feed | Active comparator | Drug: Pantoprazole 40 mg IV daily and tube feed. |
| Placebo and tube feed. | Placebo comparator | Other: Placebo and tube feed |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 years or older
- Admission to the medical ICU at University of Louisville Hospital or Jewish Hospital
- Expected need for mechanical ventilation > 48 hours
- No contraindication to EN within the first 24 hours after admission to the ICU
Key exclusion criteria (5 listed)
- Evidence of active GI bleeding during current hospitalization prior to study entry
- Admission to ICU with primary diagnosis of burn injury
- Closed head injury or increased intracranial pressure
- Partial or complete gastrectomy
- Pregnancy or lactation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pantoprazole 40 mg IV daily and tube feed.Also: Tube feed formula:(Vital AF "Advanced Formula" 1.2 Cal(TM),Abbott,Columbus,OH)Patients randomized to the control group "active Comparator" will receive tube feed plus an Pantoprazole 40 mg IV daily. | Drug | Pantoprazole 40mg IV daily and tube feed |
| Placebo and tube feedAlso: Tube feed formula:(Vital AF "Advanced Formula" 1.2 Cal(TM),Abbott,Columbus,OH)Patients randomized to Placebo group "placebo Comparator" will receive tube feed plus an Placebo. | Other | Placebo and tube feed. |
Primary outcome
Number of Subjects With GI Bleeding
Time frame: Subjects will be followed from date of randomization until discharge from the ICU or cessation of Enteral Nutrition (EN) and successful initiation of oral feeds up to 100 weeks.
1. Incidence of overt GI bleeding (as defined by the presence of coffee ground emesis, hematemesis of bright red blood, melena, or hematochezia) seen with Proton Pump Inhibitor (PPI) and EN versus EN alone in critically ill patients. 2. Incidence of significant GI bleeding, defined by a 3-point decrease in hematocrit within 24 hours accompanied by signs of overt GI bleeding, or by an unexplained 6-point decrease in hematocrit during any 48 hour period.
1 secondary outcome
Number of Subjects With ICU-acquired C. Difficile Pseudomembranous Colitis.
Time frame: Subjects will be followed until discharge from the ICU or cessation of EN and successful initiation of oral feeds up to 100 weeks.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Mohamed Saad, MD principal investigator
University of Louisville
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pantoprazole 40 mg IV daily and tube feed. in people with Gastrointestinal Hemorrhage and Clostridium Difficile Colitis, run by Mohamed Saad at 1 site in United States.
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 4 inclusion and 5 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: finished, as of the sponsor's last update on 16 Jan 2018. 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 United States. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 16 Jan 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Subjects With GI Bleeding (time frame: Subjects will be followed from date of randomization until discharge from the ICU or cessation of Enteral Nutrition (EN) and successful initiation of oral feeds up to 100 weeks.). It is what the study was designed to measure, not a finding.
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 16 Jan 2018.