China Survey of Stress Ulcer Bleeding in Critically Ill Neurosurgical Patients (SUP)

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)

Study Overview

• Status: Completed
• Conditions: Stress Ulcers; Stress-related Mucosal Disease (SRMD)

• Study Type: Observational
• Enrollment (Actual): 1416

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	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).

Secondary Outcome Measures

Outcome Measure	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).

Collaborators and Investigators

• Sponsor: AstraZeneca

Publications and helpful links

General 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.

Helpful Links

• CSR Synopsis

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: December 11, 2014
• First Submitted That Met QC Criteria: December 11, 2014
• First Posted (Estimate): December 15, 2014

Study Record Updates

• Last Update Posted (Actual): February 28, 2017
• Last Update Submitted That Met QC Criteria: February 27, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Ulcer
• Other Study ID Numbers: D1843R00056