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Pharmacokinetics/pharmacodynamics analysis of esomeprazole for stress ulcer prophylaxis in ICU patients

Pharmacokinetics/pharmacodynamics analysis of esomeprazole for stress ulcer prophylaxis in ICU patients

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300072876
Enrollment
Unknown
Registered
2023-06-27
Start date
2023-07-01
Completion date
Unknown
Last updated
2024-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

stress ulcer

Interventions

experimental group:Esomeprazole 40 mg in saline 100 ml q12h ivgtt

Sponsors

Zhongda Hospital Southeast University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Patients aged 18-80 years, regardless of gender; 2. Patients with indications for stress ulcer prevention; 3. Patients who were treated with esomeprazole; 4. ICU patients with gastric tube indwelling, fasting > 12 hours, and expected to remain fasted > 72 hours; 5. Patients or family members voluntarily participated in this clinical trial and signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Patients with known or suspected allergy or contraindication to the study drug; 2. Patients with expected survival 4; 6. Patients who may require surgical treatment during the study drug treatment ; 7. Patients with hemodynamic instability (difficult to maintain MAP >= 65 mmHg despite norepinephrine >= 1 ug/kg/min or more); 8. Patients who have used esomeprazole within 12h prior to enrollment and used drugs affecting gastric juice PH within 24 hours prior to enrollment; 9. Use of some drugs affecting the blood concentration of the study drug within the last 1 week, such as clarithromycin, erythromycin, fluconazole, voriconazole, etc.; 10. Application of high-dose steroids or non-steroidal anti-inflammatory drugs within the last 2 weeks; 11. Patients who participated in any clinical trial as a subject within 1 month prior to the screening period; 12. Pregnant or lactating women; 13. Other conditions that are judged by the investigator as unsuitable for inclusion.

Design outcomes

Primary

MeasureTime frame
Pharmacokinetic profile of esomeprazole in critically ill patients;

Secondary

MeasureTime frame
pH value of gastric juice;CYP2C19 enzyme activity;

Countries

China

Contacts

Public ContactXian Zha

Zhongda Hospital Southeast University

15951960629@163.com+86 159 5196 0629

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026