China Survey of Stress Ulcer Bleeding in Critically Ill Neurosurgical Patients

Stress Ulcers Clinical Trial

— SUP  

Official title:

China Survey of Stress Ulcer Bleeding in Critically Ill Neurosurgical Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02316990
• Other study ID #: D1843R00056
• Status: Completed
• Phase: N/A
• First received: December 11, 2014
• Last updated: February 27, 2017
• Start date: January 2015
• Est. completion date: July 2015

Study information

• Verified date: February 2017
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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]. 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

1. Primary objective: To estimate the overall incidence of upper gastrointestinal (GI) bleeding in critically ill neurosurgical patients in China.

2. 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1416
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• If participating in any clinical trial, the subject cannot take part in this study. Subjects are ineligible if they have below conditions:

1. Those who were likely to swallow blood (for example, those with severe facial trauma or epistaxis;

2. Patients with previous total gastrectomy;

3. Known upper GI lesions that might bleed (e.g., varices, polyps, tumours, etc);

4. Evidence of active GI bleeding including oesophageal and gastric variceal bleeding, Peptic Ulcer Disease (PUD)

Related Conditions & MeSH terms

• Critical Illness
• Stress Ulcers
• Stress-related Mucosal Disease (SRMD)
• Ulcer

Locations

Country	Name	City	State
China	Research Site	Beijing	Beijing
China	Research Site	Changchun	Jilin
China	Research Site	Changsha	Hunan
China	Research Site	Chengdu	Sichuan
China	Research Site	Fuzhou	Fujian
China	Research Site	Hangzhou	Zhejiang
China	Research Site	Jinan	Shandong
China	Research Site	Shanghai	Shanghai
China	Research Site	Tangshan	Hebei
China	Research Site	Tianjin	Tianjin
China	Research Site	Xi'an	Shanxi

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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).

External Links

•   CSR Synopsis