Stress UlcersSUPNCT02316990
China Survey of Stress Ulcer Bleeding in Critically Ill Neurosurgical Patients
An observational study of Stress Ulcers and Stress-related Mucosal Disease (SRMD), run by AstraZeneca at 11 sites in China.
Trial summary
Stress ulcers or stress-related mucosal disease (SRMD) is defined as "acute superficial inflammation lesions of the gastric mucosa induced when an individual is subject to abnormally elevated physiologic demands."[1] Studies have shown that SRMD occurred in 75%-100% ICU patients[1]. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Stress Ulcers, Stress-related Mucosal Disease (SRMD)
- How many people
- 1,416 participants
- Where
- 11 sitesChina
- Study dates
- Jan 2015to Jul 2015
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The subject population that will be included in the NIS are the consecutive discharged patients ≥18 years old who were hospitalized to Neurosurgical departments and whose GCS≤10[4] within 24 hours of lesion/admission. The subjects will be focused on brain trauma, cerebral haemorrhage or postoperative brain tumour population.
Who may be able to join
- The subject population that will be included in the NIS are the consecutive discharged patients ≥18 years old who were hospitalized to Neurosurgical departments. Those whose Glasgow Coma Scale (GCS) ≤10[4] within 24 hours of lesion/admission will be defined as critically ill patients. Three kinds of cases will be included: brain trauma critically ill patients, cerebral haemorrhage critically ill patients or postoperative brain tumour critically ill patients.
Who cannot join
- If participating in any clinical trial, the subject cannot take part in this study. Subjects are ineligible if they have below conditions:
- Those who were likely to swallow blood (for example, those with severe facial trauma or epistaxis;
- Patients with previous total gastrectomy;
- Known upper GI lesions that might bleed (e.g., varices, polyps, tumours, etc);
- Evidence of active GI bleeding including oesophageal and gastric variceal bleeding, Peptic Ulcer Disease (PUD)
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
China11 sites
Research Site
Beijing, Beijing Municipality
Research Site
Changchun, Jilin
Research Site
Changsha, Hunan
Research Site
Chengdu, Sichuan
Research Site
Fuzhou, Fujian
Research Site
Hangzhou, Zhejiang
Research Site
Jinan, Shandong
Research Site
Shanghai, Shanghai Municipality
Research Site
Tangshan, Hebei
Research Site
Tianjin, Tianjin Municipality
Research Site
Xi’an, Shanxi
About this study
Stress ulcers or stress-related mucosal disease (SRMD) is defined as "acute superficial inflammation lesions of the gastric mucosa induced when an individual is subject to abnormally elevated physiologic demands."[1] Studies have shown that SRMD occurred in 75%-100% ICU patients[1]. Gastrointestinal bleeding due to SRMD is an important complication in critically ill patients. The frequency of clinically important bleeding ranged from 5.3% to 33%.[2] The mortality in ICU patients with stress related bleeding approaches 50%, which is much higher than the patients without bleeding (9%). [3] In 1999, the American Society of Health-System Pharmacists (ASHP) published guidelines on the use of stress ulcer prophylaxis in medical, surgical, respiratory, and pediatric ICU patients [2]. PPIs and H2RA are widely used in China current clinical practice for the prevention of stress ulcer bleeding. However, there is no epidemiology data to show the risk factors for stress ulcer bleeding and the bleeding rate of Chinese neurosurgical critically ill patients who are usually suffering from brain trauma, cerebral haemorrhage or brain tumour operation. Information is needed to know about the characteristics in Chinese critically ill neurosurgical patients.
Objectives of this Non-Interventional Study Primary
Read more
- Primary objective: To estimate the overall incidence of upper gastrointestinal (GI) bleeding in critically ill neurosurgical patients in China.
- Main secondary objective
- To estimate the incidence of upper GI bleeding with clinically significant complications in critically ill neurosurgical patients in China.
- To estimate the incidence of any overt upper GI bleeding without clinically significant complications in critically ill neurosurgical patients in China.
- To assess time to upper GI bleeding after a cerebral lesion.
- To investigate potential risk factors associated with upper GI bleeding, and assess how common certain risk factors occurred in upper GI bleeding patients.
- To assess the overall incidence of upper GI bleeding in critically ill patients by different risk factors for upper GI bleeding.
- To investigate the drugs, the route of administration, the doses and the duration commonly used for stress ulcer prophylaxis.
- To investigate the proportion of ICU patients with nasogastric tube, and the duration of nasogastric tube. (ICU: Intensive care unit PPIs: Proton pump inhibitors H2RA: H2 receptor antagonist)
- Medical subject headings
- Duodenal Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| patients ≥18 ,Neurosurgical departments and whose GCS≤10[4] | The subject population that will be included in the NIS are the consecutive discharged patients ≥18 years old who were hospitalized to Neurosurgical departments and whose GCS≤10[4] within 24 hours of lesion/admission.(GCS: Glasgow Coma Scale NIS: Non-Interventional Study ) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary variable is the overall incidence of upper GI bleeding in critically ill neurosurgical patients
Measured: during the first 14 days (up to 14 days) after the cerebral lesion (trauma, haemorrhage or postoperative).
Secondary outcomes (1)
The incidence of upper GI bleeding with clinically significant complications in critically ill neurosurgical patients
Measured: during the first 14 days (up to 14 days) after the cerebral lesion (trauma, haemorrhage or postoperative).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2014 (estimated)
- Study startJan 2015
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stress UlcersStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 1,416 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02316990
- Sponsor's protocol ID
- D1843R00056
- Acronym
- SUP
- Status last verified
- Feb 2017
- First submitted
- 11 Dec 2014
- Last updated
- 28 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Wei J, Jiang R, Li L, Kang D, Gao G, You C, Zhang J, Gao L, Huang Q, Luo D, Zhao G, Zhang H, Wang S, Wang R. Stress-related upper gastrointestinal bleeding in adult neurocritical care patients: a Chinese multicenter, retrospective study. Curr Med Res Opin. 2019 Feb;35(2):181-187. doi: 10.1080/03007995.2018.1448261. Epub 2018 May 30.
PubMed 29499622
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- China Survey of Stress Ulcer Bleeding in Critically Ill Neurosurgical Patients
- ClinicalTrials.gov ID
- NCT02316990
- Acronym / sponsor ID
- SUP / D1843R00056
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,416 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jan 2015
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 15 Dec 2014 (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.
Stress ulcers or stress-related mucosal disease (SRMD) is defined as "acute superficial inflammation lesions of the gastric mucosa induced when an individual is subject to abnormally elevated physiologic demands."[1] Studies have shown that SRMD occurred in 75%-100% ICU patients[1]. Gastrointestinal bleeding due to SRMD is an important complication in critically ill patients. The frequency of clinically important bleeding ranged from 5.3% to 33%.[2] The mortality in ICU patients with stress related bleeding approaches 50%, which is much higher than the patients without bleeding (9%). [3] In 1999, the American Society of Health-System Pharmacists (ASHP) published guidelines on the use of stress ulcer prophylaxis in medical, surgical, respiratory, and pediatric ICU patients [2]. PPIs and H2RA are widely used in China current clinical practice for the prevention of stress ulcer bleeding. However, there is no epidemiology data to show the risk factors for stress ulcer bleeding and the bleeding rate of Chinese neurosurgical critically ill patients who are usually suffering from brain trauma, cerebral haemorrhage or brain tumour operation. Information is needed to know about the characteristics in Chinese critically ill neurosurgical patients.
Objectives of this Non-Interventional Study Primary
- Primary objective: To estimate the overall incidence of upper gastrointestinal (GI) bleeding in critically ill neurosurgical patients in China.
- Main secondary objective
- To estimate the incidence of upper GI bleeding with clinically significant complications in critically ill neurosurgical patients in China.
- To estimate the incidence of any overt upper GI bleeding without clinically significant complications in critically ill neurosurgical patients in China.
- To assess time to upper GI bleeding after a cerebral lesion.
- To investigate potential risk factors associated with upper GI bleeding, and assess how common certain risk factors occurred in upper GI bleeding patients.
- To assess the overall incidence of upper GI bleeding in critically ill patients by different risk factors for upper GI bleeding.
- To investigate the drugs, the route of administration, the doses and the duration commonly used for stress ulcer prophylaxis.
- To investigate the proportion of ICU patients with nasogastric tube, and the duration of nasogastric tube. (ICU: Intensive care unit PPIs: Proton pump inhibitors H2RA: H2 receptor antagonist)
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients ≥18 ,Neurosurgical departments and whose GCS≤10[4] | – | –The subject population that will be included in the NIS are the consecutive discharged patients ≥18 years old who were hospitalized to Neurosurgical departments and whose GCS≤10[4] within 24 hours of lesion/admission.(GCS: Glasgow Coma Scale NIS: Non-Interventional Study ) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The subject population that will be included in the NIS are the consecutive discharged patients ≥18 years old who were hospitalized to Neurosurgical departments and whose GCS≤10[4] within 24 hours of lesion/admission. The subjects will be focused on brain trauma, cerebral haemorrhage or postoperative brain tumour population.
Key inclusion criteria (1 listed)
- The subject population that will be included in the NIS are the consecutive discharged patients ≥18 years old who were hospitalized to Neurosurgical departments. Those whose Glasgow Coma Scale (GCS) ≤10[4] within 24 hours of lesion/admission will be defined as critically ill patients. Three kinds of cases will be included: brain trauma critically ill patients, cerebral haemorrhage critically ill patients or postoperative brain tumour critically ill patients.
Key exclusion criteria (5 listed)
- If participating in any clinical trial, the subject cannot take part in this study. Subjects are ineligible if they have below conditions:
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
The primary variable is the overall incidence of upper GI bleeding in critically ill neurosurgical patients
Time frame: during the first 14 days (up to 14 days) after the cerebral lesion (trauma, haemorrhage or postoperative).
1 secondary outcome
The incidence of upper GI bleeding with clinically significant complications in critically ill neurosurgical patients
Time frame: during the first 14 days (up to 14 days) after the cerebral lesion (trauma, haemorrhage or postoperative).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2017.
- Derived from this study: PubMed 29499622Wei J, Jiang R, Li L, Kang D, Gao G, You C, Zhang J, Gao L, Huang Q, Luo D, Zhao G, Zhang H, Wang S, Wang R. Stress-related upper gastrointestinal bleeding in adult neurocritical care patients: a Chinese multicenter, retrospective study. Curr Med Res Opin. 2019 Feb;35(2):181-187. doi: 10.1080/03007995.2018.1448261. Epub 2018 May 30.
- CSR SynopsisLink provided by the sponsor.
Related trials for Stress Ulcers
RecruitingObservational study
Association of Prophylactic Use of Stress Ulcer Drugs and Clinical Outcomes in Patients With Acute Anterior Circulation Thrombectomy
Acute Ischemic Stroke
RecruitingObservational study
Efficacy and Safety of Esomeprazole 40 mg IV in Post-Surgical Patients Admitted to the ICU
Stress Ulcers, Reflux Episodes
Recruiting
Effect of Stress Ball Applied During Surgical Debridement/Dressing on Pain, Distress, and Physiological Parameters in Patients With Diabetic Foot Ulcers
Diabetic Foot Ulcer Associated With Type II Diabetes Mellitus
Not yet recruiting
A Mindfulness-based Stress Reduction Program for IBD
Inflammatory Bowel Disease (Crohn&Amp;#39;s Disease and Ulcerative Colitis)
Recruiting
Evaluating the Efficacy of Pulsating Electromagnetic Field Therapy by CRAD ULCER X-01 for Diabetic Foot Ulcers
Diabetic Foot Ulcer, Diabetes Mellitus (DM)
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.
The record lists no contact. Use the official record to reach the sponsor.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stress Ulcers and Stress-related Mucosal Disease (SRMD), run by AstraZeneca at 11 sites in China.
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 1 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 28 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The primary variable is the overall incidence of upper GI bleeding in critically ill neurosurgical patients (time frame: during the first 14 days (up to 14 days) after the cerebral lesion (trauma, haemorrhage or postoperative).). 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 NCT02316990, which also lists 1 linked publication.
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 28 Feb 2017.