Stress Ulcers Clinical Trial
Official title:
China Survey of Stress Ulcer Bleeding in Critically Ill Neurosurgical Patients
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)
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02467621 -
Stress Ulcer Prophylaxis in the Intensive Care Unit
|
Phase 4 |