Gastric Ulcer
Conditions
Keywords
stress ulcer, critically ill, gastric acid, gastric aspirates, esomeprazole
Brief summary
This study is being done to see if Nexium I.V. can reduce and control stomach acid in mechanically ventilated, critically ill patients in an Intensive Care Unit setting.
Interventions
DRUGEsomeprazole Sodium
Sponsors
AstraZeneca
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Critically ill male or female subjects 18 years or older who have a baseline gastric aspirate pH less then or equal to 4 * Subjects admitted to an ICU requiring mechanically ventilated * Subjects will have at least one additional stress ulcer risk factor
Exclusion criteria
* Anticipated use of pre-pyloric enteral feeding after screening until the end of study * Physician estimated survival of less then 96 hours * Anticipation of major surgery within 96 hours of study enrollment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of the study is to assess gastric acid suppression by esomeprazole iv in critically ill subjects | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary objective is to assess time to stable pH greater then or equal to 4 from start of drug | — |
Countries
United States
Outcome results
None listed