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China Survey of Stress Ulcer Bleeding in Critically Ill Neurosurgical Patients

NCT02316990 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1416

Last updated 2017-02-28

No results posted yet for this study

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)

Conditions

  • Stress Ulcers
  • Stress-related Mucosal Disease (SRMD)

Sponsors & Collaborators

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2015-07-31
Completion
2015-07-31

Countries

  • China

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02316990 on ClinicalTrials.gov