China Survey of Stress Ulcer Bleeding in Critically Ill Neurosurgical Patients

NCT02316990 | Completed

• 1 other identifier: D1843R00056
• Study Type: observational
• Target: 1,416
• Locations: 1 country
• Sites: 11

Brief 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\[1\]. 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

• 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)

Conditions

Stress Ulcers; Stress-related Mucosal Disease (SRMD)

Outcome Measures

Primary Outcomes (1)

• 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).

Secondary Outcomes (1)

• 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).

Study Arms (1)

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 )

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (11)

Research Site

Beijing, Beijing Municipality, China

Location

Research Site

Fuzhou, Fujian, China

Location

Research Site

Tangshan, Hebei, China

Location

Research Site

Changsha, Hunan, China

Location

Research Site

Changchun, Jilin, China

Location

Research Site

Jinan, Shandong, China

Location

Research Site

Shanghai, Shanghai Municipality, China

Location

Research Site

Xi’an, Shanxi, China

Location

Research Site

Chengdu, Sichuan, China

Location

Research Site

Tianjin, Tianjin Municipality, China

Location

Research Site

Hangzhou, Zhejiang, China

Location

Related Publications (1)

• 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.

  PMID: 29499622 DERIVED

Related Links

• CSR Synopsis

MeSH Terms

Conditions

Duodenal Ulcer

Condition Hierarchy (Ancestors)

Peptic Ulcer; Duodenal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Stomach Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2014
• First Posted: December 15, 2014
• Study Start: January 1, 2015
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: February 28, 2017

Record last verified: 2017-02

Locations

CN (11)