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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
(ICU: Intensive care unit PPIs: Proton pump inhibitors H2RA: H2 receptor antagonist)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 ) |
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| Measure | Description | Time Frame |
|---|---|---|
| The primary variable is the overall incidence of upper GI bleeding in critically ill neurosurgical patients | during the first 14 days (up to 14 days) after the cerebral lesion (trauma, haemorrhage or postoperative). |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of upper GI bleeding with clinically significant complications in critically ill neurosurgical patients | during the first 14 days (up to 14 days) after the cerebral lesion (trauma, haemorrhage or postoperative). |
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Inclusion Criteria:
Exclusion Criteria:
If participating in any clinical trial, the subject cannot take part in this study. Subjects are ineligible if they have below conditions:
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Beijing | Beijing Municipality | China | |||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29499622 | Derived | 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. |
| Label | URL |
|---|---|
| CSR Synopsis | View source |
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| ID | Term |
|---|---|
| D004381 | Duodenal Ulcer |
| ID | Term |
|---|---|
| D010437 | Peptic Ulcer |
| D004378 | Duodenal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
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| Fuzhou |
| Fujian |
| China |
| Research Site | Tangshan | Hebei | China |
| Research Site | Changsha | Hunan | China |
| Research Site | Changchun | Jilin | China |
| Research Site | Jinan | Shandong | China |
| Research Site | Shanghai | Shanghai Municipality | China |
| Research Site | Xi’an | Shanxi | China |
| Research Site | Chengdu | Sichuan | China |
| Research Site | Tianjin | Tianjin Municipality | China |
| Research Site | Hangzhou | Zhejiang | China |
| D004066 |
| Digestive System Diseases |
| D013272 | Stomach Diseases |