Enteral NutritionNCT03098537
Effects of Enteral Nutrition on Stress Ulcer Hemorrage. Multicenter Randomized Controlled Trial
A study testing enteral nutrition + proton pump inhibitor and enteral nutrition only in people with Enteral Nutrition and Gastro Intestinal Bleeding, run by TC Erciyes University at 1 site in Turkey (Türkiye).
Trial summary
Enteral nutrition can provides prophylaxis against stress ulcer bleeding in critically ill patients and there may be no need to use acid suppressing drugs for stress ulcer bleeding prophylaxis in these patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Enteral Nutrition, Gastro Intestinal Bleeding, Stress Ulcer Prophylaxis
- What is being tested?
- enteral nutrition + proton pump inhibitor and enteral nutrition only
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2016to 1 Dec 2017
- Phase
- Interventional
- 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
Who may be able to join
- Age 18 years or older
- Admission to ICU
- Expected to stay in ICU >24 hours
- No contraindications to EN within the first 24 hours after admission to the intensive care unit
Who cannot join
- Evidence of active GI bleeding during current hospitalization prior to study entry
- Coagulopathy (PLT<50.000, INR>1.5, aPTT>2xcontrol)
- Patients receiving acid suppressing drugs prior to admission
- Pregnancy or lactation
- History/documented gastric ulcer
- Burn>30% body surface area
Show all 12Show fewer
- Head injury or increased intracranial pressure
- Partial or complete gastrectomy
- Shock
- Multi-system trauma
- Exposure to gastric irritant drugs
- Patients not giving informed consent
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Erciyes University Medical School
Kayseri, 38039
Kudret Dogru, MD, +90 352 207 6666 ext. 20000, kdogru@erciyes.edu.tr
Emine Alp, MD, +90 352 207 6666 ext. 20000, ealp@erciyes.edu.tr
About this study
Official title: Effects of Enteral Nutrition on Stress Ulcer Hemorrage. Multicenter Randomized Controlled
Enteral nutrition can provides prophylaxis against stress ulcer bleeding in critically ill patients and there may be no need to use acid suppressing drugs for stress ulcer bleeding prophylaxis in these patients. Half of the patients on enteral nutrition will not receive any acid suppressing drugs while other half receives it. They will be followed for gastrointestinal bleeding.
Read the detailed description
Mucosal erosions can occur on luminal surface of stomach in approximately 75-100% patients during the first 24 hours of intensive care unit admission. These erosions often cause bleeding with penetrating superficial capillaries. Clinically significant bleeding (Significant decrease in blood pressure or decrease in hemoglobin level of more than 2 g / dL) appears to be less than 5% in ICU patients.
Enteral nutrition (EN) has protective effects against stress ulcer bleeding by neutralizing the acidic pH in the stomach lumen, providing a structural and functional integrity of the mucosal surface and trophic effect on the GI mucosa. These effects have been shown in some studies. The above-mentioned studies are inadequate for clinicians to make suggestions for relation between enteral nutrition and stress ulcer hemorrhage.
The risk factors for stress ulcer hemorrhage are mechanical ventilation, coagulopathy and burns.
Proton pump inhibitors (PPI) and histamine receptor blockers (H2RB) are the main drugs used for stress ulcer bleeding prophylaxis.
Studies have shown that 90% of patients admitted to intensive care units receive prophylaxis for stress ulcer bleeding.
Drugs (H2RB, PPI) used for prophylaxis against stress ulcer bleeding have some undesirable harmful effects in critical illnesses. These drugs, which suppress gastric acid secretion, can cause hospital-associated pneumonia and Clostridium difficile enterocolitis.
The studies, for clinical proposals are generally performed in the 1980s and early 1990s. Oral intake was stopped in most of the critically ill patients and early enteral nutrition was not widely used at the time of these major studies performed. Patients who are receiving EN have been shown to develop less stress ulcer bleeding in some studies. In a limited number of animal studies, enteral feeding has been shown to protect stress-related mucosal damage in the gastric mucosa.
- Conditions
- Enteral Nutrition, Gastro Intestinal Bleeding, Stress Ulcer Prophylaxis, Proton Pump Inhibitor
- Being tested
- enteral nutrition + proton pump inhibitor, enteral nutrition only
- Medical subject headings
- Gastrointestinal Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
enteral nutrition + proton pump inhibitorDrug
Critically ill patients receiving any form of enteral nutrition will be included into the study. The patients will be randomized either enteral nutrition only group or enteral nutrition and proton pump inhibitors group. This group will receive enteral nutrition and proton pump inhibitor
enteral nutrition onlyOther
Critically ill patients receiving any form of enteral nutrition will be included into the study. The patients will be randomized either enteral nutrition only group or enteral nutrition and proton pump inhibitors group. This group will receive only enteral nutrition.
| Study group | Role | What they receive |
|---|---|---|
| Enteral nutrion only | Active comparator | Not described Receives: Other: enteral nutrition only |
| Enteral nutrion + proton pump inhibitor | Other | Not described Receives: Drug: enteral nutrition + proton pump inhibitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
GI bleeding
Overt GI bleeding (presence of coffee ground emesis hematemesis, melena or hematochezia.
Significant GI bleeding, defined by 3-point decrease in hematocrit within 24 hours accompanied by 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 up to four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2017
- Study start1 Aug 2016
- Primary completion1 Aug 2017 (estimated)
- Study completion1 Dec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Enteral NutritionStudies of the same condition, open and under way.
- More trials run by TC Erciyes UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kursat Gundogan, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03098537
- Sponsor's protocol ID
- 2016/427
- Status last verified
- Mar 2017
- First submitted
- 20 Mar 2017
- Last updated
- 31 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cook DJ, Fuller HD, Guyatt GH, Marshall JC, Leasa D, Hall R, Winton TL, Rutledge F, Todd TJ, Roy P, et al. Risk factors for gastrointestinal bleeding in critically ill patients. Canadian Critical Care Trials Group. N Engl J Med. 1994 Feb 10;330(6):377-81. doi: 10.1056/NEJM199402103300601.
PubMed 8284001Raff T, Germann G, Hartmann B. The value of early enteral nutrition in the prophylaxis of stress ulceration in the severely burned patient. Burns. 1997 Jun;23(4):313-8. doi: 10.1016/s0305-4179(97)89875-0.
PubMed 9248640Ephgrave KS, Kleiman-Wexler RL, Adair CG. Enteral nutrients prevent stress ulceration and increase intragastric volume. Crit Care Med. 1990 Jun;18(6):621-4. doi: 10.1097/00003246-199006000-00009.
PubMed 2111755Shorr LD, Sirinek KR, Page CP, Levine BA. The role of glucose in preventing stress gastric mucosal injury. J Surg Res. 1984 Apr;36(4):384-8. doi: 10.1016/0022-4804(84)90115-x.
PubMed 6546772Pingleton SK, Hadzima SK. Enteral alimentation and gastrointestinal bleeding in mechanically ventilated patients. Crit Care Med. 1983 Jan;11(1):13-6. doi: 10.1097/00003246-198301000-00005.
PubMed 6401236Cook DJ, Reeve BK, Guyatt GH, Heyland DK, Griffith LE, Buckingham L, Tryba M. Stress ulcer prophylaxis in critically ill patients. Resolving discordant meta-analyses. JAMA. 1996 Jan 24-31;275(4):308-14.
PubMed 8544272Daley RJ, Rebuck JA, Welage LS, Rogers FB. Prevention of stress ulceration: current trends in critical care. Crit Care Med. 2004 Oct;32(10):2008-13. doi: 10.1097/01.ccm.0000142398.73762.20.
PubMed 15483408Pisegna JR. Pharmacology of acid suppression in the hospital setting: focus on proton pump inhibition. Crit Care Med. 2002 Jun;30(6 Suppl):S356-61. doi: 10.1097/00003246-200206001-00003.
PubMed 12072661Lin PC, Chang CH, Hsu PI, Tseng PL, Huang YB. The efficacy and safety of proton pump inhibitors vs histamine-2 receptor antagonists for stress ulcer bleeding prophylaxis among critical care patients: a meta-analysis. Crit Care Med. 2010 Apr;38(4):1197-205. doi: 10.1097/CCM.0b013e3181d69ccf.
PubMed 20173630Herzig SJ, Howell MD, Ngo LH, Marcantonio ER. Acid-suppressive medication use and the risk for hospital-acquired pneumonia. JAMA. 2009 May 27;301(20):2120-8. doi: 10.1001/jama.2009.722.
PubMed 19470989Cunningham R, Dale B, Undy B, Gaunt N. Proton pump inhibitors as a risk factor for Clostridium difficile diarrhoea. J Hosp Infect. 2003 Jul;54(3):243-5. doi: 10.1016/s0195-6701(03)00088-4.
PubMed 12855243Dial S, Alrasadi K, Manoukian C, Huang A, Menzies D. Risk of Clostridium difficile diarrhea among hospital inpatients prescribed proton pump inhibitors: cohort and case-control studies. CMAJ. 2004 Jul 6;171(1):33-8. doi: 10.1503/cmaj.1040876.
PubMed 15238493
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Enteral Nutrition on Stress Ulcer Hemorrage. Multicenter Randomized Controlled
- ClinicalTrials.gov ID
- NCT03098537
- Acronym / sponsor ID
- 2016/427
- Conditions
- Enteral Nutrition, Gastro Intestinal Bleeding, Stress Ulcer Prophylaxis, Proton Pump Inhibitor
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- 1 Aug 2016 (actual)
- Primary completion
- 1 Aug 2017 (estimated)
- Study completion
- 1 Dec 2017 (estimated)
- First posted
- 31 Mar 2017 (actual)
- 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.
Enteral nutrition can provides prophylaxis against stress ulcer bleeding in critically ill patients and there may be no need to use acid suppressing drugs for stress ulcer bleeding prophylaxis in these patients. Half of the patients on enteral nutrition will not receive any acid suppressing drugs while other half receives it. They will be followed for gastrointestinal bleeding.
Detailed description
Mucosal erosions can occur on luminal surface of stomach in approximately 75-100% patients during the first 24 hours of intensive care unit admission. These erosions often cause bleeding with penetrating superficial capillaries. Clinically significant bleeding (Significant decrease in blood pressure or decrease in hemoglobin level of more than 2 g / dL) appears to be less than 5% in ICU patients.
Enteral nutrition (EN) has protective effects against stress ulcer bleeding by neutralizing the acidic pH in the stomach lumen, providing a structural and functional integrity of the mucosal surface and trophic effect on the GI mucosa. These effects have been shown in some studies. The above-mentioned studies are inadequate for clinicians to make suggestions for relation between enteral nutrition and stress ulcer hemorrhage.
The risk factors for stress ulcer hemorrhage are mechanical ventilation, coagulopathy and burns.
Proton pump inhibitors (PPI) and histamine receptor blockers (H2RB) are the main drugs used for stress ulcer bleeding prophylaxis.
Studies have shown that 90% of patients admitted to intensive care units receive prophylaxis for stress ulcer bleeding.
Drugs (H2RB, PPI) used for prophylaxis against stress ulcer bleeding have some undesirable harmful effects in critical illnesses. These drugs, which suppress gastric acid secretion, can cause hospital-associated pneumonia and Clostridium difficile enterocolitis.
The studies, for clinical proposals are generally performed in the 1980s and early 1990s. Oral intake was stopped in most of the critically ill patients and early enteral nutrition was not widely used at the time of these major studies performed. Patients who are receiving EN have been shown to develop less stress ulcer bleeding in some studies. In a limited number of animal studies, enteral feeding has been shown to protect stress-related mucosal damage in the gastric mucosa.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enteral nutrion only | Active comparator | Other: enteral nutrition only |
| Enteral nutrion + proton pump inhibitor | Other | Drug: enteral nutrition + proton pump inhibitor |
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 ICU
- Expected to stay in ICU >24 hours
- No contraindications to EN within the first 24 hours after admission to the intensive care unit
Key exclusion criteria (12 listed)
- Evidence of active GI bleeding during current hospitalization prior to study entry
- Coagulopathy (PLT<50.000, INR>1.5, aPTT>2xcontrol)
- Patients receiving acid suppressing drugs prior to admission
- Pregnancy or lactation
- History/documented gastric ulcer
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 |
|---|---|---|
| enteral nutrition + proton pump inhibitorCritically ill patients receiving any form of enteral nutrition will be included into the study. The patients will be randomized either enteral nutrition only group or enteral nutrition and proton pump inhibitors group. This group will receive enteral nutrition and proton pump inhibitor | Drug | Enteral nutrion + proton pump inhibitor |
| enteral nutrition onlyCritically ill patients receiving any form of enteral nutrition will be included into the study. The patients will be randomized either enteral nutrition only group or enteral nutrition and proton pump inhibitors group. This group will receive only enteral nutrition. | Other | Enteral nutrion only |
Primary outcome
GI bleeding
Time frame: Subjects will be followed from date of randomization until discharge from the ICU or cessation of enteral nutrition up to four weeks
Overt GI bleeding (presence of coffee ground emesis hematemesis, melena or hematochezia. Significant GI bleeding, defined by 3-point decrease in hematocrit within 24 hours accompanied by overt GI bleeding or by an unexplained 6-point decrease in hematocrit during any 48 hour period.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2017.
- Background: PubMed 8284001Cook DJ, Fuller HD, Guyatt GH, Marshall JC, Leasa D, Hall R, Winton TL, Rutledge F, Todd TJ, Roy P, et al. Risk factors for gastrointestinal bleeding in critically ill patients. Canadian Critical Care Trials Group. N Engl J Med. 1994 Feb 10;330(6):377-81. doi: 10.1056/NEJM199402103300601.
- Background: PubMed 9248640Raff T, Germann G, Hartmann B. The value of early enteral nutrition in the prophylaxis of stress ulceration in the severely burned patient. Burns. 1997 Jun;23(4):313-8. doi: 10.1016/s0305-4179(97)89875-0.
- Background: PubMed 2111755Ephgrave KS, Kleiman-Wexler RL, Adair CG. Enteral nutrients prevent stress ulceration and increase intragastric volume. Crit Care Med. 1990 Jun;18(6):621-4. doi: 10.1097/00003246-199006000-00009.
- Background: PubMed 6546772Shorr LD, Sirinek KR, Page CP, Levine BA. The role of glucose in preventing stress gastric mucosal injury. J Surg Res. 1984 Apr;36(4):384-8. doi: 10.1016/0022-4804(84)90115-x.
- Background: PubMed 6401236Pingleton SK, Hadzima SK. Enteral alimentation and gastrointestinal bleeding in mechanically ventilated patients. Crit Care Med. 1983 Jan;11(1):13-6. doi: 10.1097/00003246-198301000-00005.
- Background: PubMed 8544272Cook DJ, Reeve BK, Guyatt GH, Heyland DK, Griffith LE, Buckingham L, Tryba M. Stress ulcer prophylaxis in critically ill patients. Resolving discordant meta-analyses. JAMA. 1996 Jan 24-31;275(4):308-14.
- Background: PubMed 15483408Daley RJ, Rebuck JA, Welage LS, Rogers FB. Prevention of stress ulceration: current trends in critical care. Crit Care Med. 2004 Oct;32(10):2008-13. doi: 10.1097/01.ccm.0000142398.73762.20.
- Background: PubMed 12072661Pisegna JR. Pharmacology of acid suppression in the hospital setting: focus on proton pump inhibition. Crit Care Med. 2002 Jun;30(6 Suppl):S356-61. doi: 10.1097/00003246-200206001-00003.
- Background: PubMed 20173630Lin PC, Chang CH, Hsu PI, Tseng PL, Huang YB. The efficacy and safety of proton pump inhibitors vs histamine-2 receptor antagonists for stress ulcer bleeding prophylaxis among critical care patients: a meta-analysis. Crit Care Med. 2010 Apr;38(4):1197-205. doi: 10.1097/CCM.0b013e3181d69ccf.
- Background: PubMed 19470989Herzig SJ, Howell MD, Ngo LH, Marcantonio ER. Acid-suppressive medication use and the risk for hospital-acquired pneumonia. JAMA. 2009 May 27;301(20):2120-8. doi: 10.1001/jama.2009.722.
- Background: PubMed 12855243Cunningham R, Dale B, Undy B, Gaunt N. Proton pump inhibitors as a risk factor for Clostridium difficile diarrhoea. J Hosp Infect. 2003 Jul;54(3):243-5. doi: 10.1016/s0195-6701(03)00088-4.
- Background: PubMed 15238493Dial S, Alrasadi K, Manoukian C, Huang A, Menzies D. Risk of Clostridium difficile diarrhea among hospital inpatients prescribed proton pump inhibitors: cohort and case-control studies. CMAJ. 2004 Jul 6;171(1):33-8. doi: 10.1503/cmaj.1040876.
- Individual participant dataSharing planned: No
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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?
A study testing enteral nutrition + proton pump inhibitor and enteral nutrition only in people with Enteral Nutrition and Gastro Intestinal Bleeding, run by TC Erciyes University at 1 site in Turkey (Türkiye).
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 12 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 31 Mar 2017. 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 Turkey (Türkiye). 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 Kurat Gundogan, MD (+90 352 207 6666 ext. 21919, kgundogan@erciyes.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GI bleeding (time frame: Subjects will be followed from date of randomization until discharge from the ICU or cessation of enteral nutrition up to four weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03098537, which also lists 12 linked publications.
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 31 Mar 2017.