중환자실에 입원한 수술 후 환자에서 Esomeprazole 40 mg 정맥 투여의 유효성과 안전성
중환자실 입원 수술 후 환자에서 에소메프라졸 40mg 정맥투여의 유효성 및 안전성 (EPIC-ICU)
Critically ill patients admitted to intensive care units (ICUs) are predisposed to upper gastrointestinal (GI) bleeding secondary to stress-related mucosal damage. The two most significant independent risk factors for stress ulceration and subsequent GI bleeding in this setting are mechanical ventilation and coagulopathy.1,2 Observational data indicate that proton pump inhibitors (PPIs) remain the most frequently employed prophylactic agents in the ICU.3
Comparative studies evaluating the efficacy of PPIs have shown a positive correlation between their pharmacokinetic properties and acid-suppressive activity. Among available PPIs, esomeprazole demonstrates superior pharmacokinetic characteristics, translating into more effective acid control in clinical use.7,8 In fact, one study reported that the area under the curve (AUC) for esomeprazole was nearly twice that of omeprazole at equivalent doses (14), supporting its enhanced acid-suppressive effect and prolonged maintenance of intragastric pH > 4.9
연구 개요
상세 설명
Esomeprazole, a PPI, has demonstrated robust efficacy in the management of gastroesophageal reflux disease (GERD).4 An intravenous (IV) formulation has been developed to facilitate administration in patients for whom oral therapy is not feasible. A study assessed the safety profile after 1 and 4 weeks, as well as the efficacy after 4 weeks of treatment with esomeprazole 40 mg once daily. Their findings indicated that esomeprazole, administered either as an IV bolus, IV infusion, or orally for 1 week followed by 3 weeks of oral dosing, was well tolerated and effectively promoted mucosal healing.5 Similarly, another studyreported significant improvements in symptom control, with mean reductions in heartburn (91.6%), acid regurgitation (96%), belching (96.8%), epigastric pain (88.4%), and dysphagia (84.7%). Based on both investigator and patient global assessments, 89.2% of cases were rated as having an excellent to good therapeutic response.6
Comparative studies evaluating the efficacy of PPIs have shown a positive correlation between their pharmacokinetic properties and acid-suppressive activity. Among available PPIs, esomeprazole demonstrates superior pharmacokinetic characteristics, translating into more effective acid control in clinical use.7,8 In fact, one study reported that the area under the curve (AUC) for esomeprazole was nearly twice that of omeprazole at equivalent doses (14), supporting its enhanced acid-suppressive effect and prolonged maintenance of intragastric pH > 4.9
In view of this evidence, the present study was designed to evaluate the efficacy of IV esomeprazole for intragastric pH control in post-surgical patients admitted to the ICU, as well as to assess its safety and tolerability in this population
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: G V RAO, MBBS,MAMS,FRCS
- 전화번호: +91-9182645727
- 이메일: gvraoaig@gmail.com
연구 장소
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Telangana
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Hyderabad, Telangana, 인도, 500032
- 모병
- AIG Hospitals
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연락하다:
- AIG Hospitals
- 전화번호: +91 4042444222
- 이메일: info@aighospitals.com
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
50
설명
Inclusion Criteria:
- Adult patients aged 18-75 years admitted to an ICU post-surgery.
- Non-esophagogastric post-surgical patients.
- An anticipated ICU stay for at least 72 hours.
- Willing to provide consent.
Exclusion Criteria:
- Allergy to the study medications or excipients
- Need for enteral feeding
- Estimated survival of <96 hours
- Pregnant and breastfeeding females.
- History of severe thrombocytopenia, coagulopathy, Child-Pugh Class C liver disease, or organ transplant requiring immunosuppressive therapy.
- On other PPIs and/or NSAIDs for last 48 hrs.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: COHORT
- 시간 관점: PROSPECTIVE
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
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Single Prospective Observational Cohort - Post-surgical ICU Patients
Eligible post-surgical ICU patients will be enrolled into a single prospective observational cohort after providing written informed consent. All patients will receive Esomeprazole 40 mg intravenous as part of routine post-operative ICU care. Gastric pH impedance monitoring, endoscopic evaluations, and clinical assessments will be performed at predefined time points to observe gastric acid control, reflux parameters, safety, and tolerability. No randomization, blinding, or comparator group is involved. |
Esomeprazole 40 mg IV will be administered following extubation (~12 hours post-surgery) and subsequently at 24-hour intervals (Day 2 and Day 3) as per routine ICU clinical practice. The drug is not assigned for research purposes but is prescribed as standard care. The study will only observe and record gastric pH parameters, reflux episodes, endoscopic findings, safety, and tolerability. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Proportion of time intragastric pH ≥4 during the 72 hours post dosing
기간: From enrollment to the end of treatment at 72 hours
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Proportion of time intragastric pH ≥4 during the 72 hours post dosing |
From enrollment to the end of treatment at 72 hours
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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• To assess the safety and tolerability of IV Esomeprazole in this patient population, including the incidence of stress ulcers and reflux episodes.
기간: From enrollment to the end of treatment at 72 hours
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• Incidence of stress ulcers and reflux episodes with the help of Proportion of time intragastric pH > 5 and > 6 and Mean intragastric pH on days 1, 2, and 3 post dosing (0-24, 0-48, and 48-72 hrs.) |
From enrollment to the end of treatment at 72 hours
|
공동 작업자 및 조사자
수사관
- 수석 연구원: G V RAO, MBBS,MAMS,FRCS, Asian Institute Of Gastroenterology Private Limited
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- EPIC-ICU
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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