ACTRN12616000481471已完成3 期
A multi-centre, cluster randomised, crossover, registry trial comparing the safety and efficacy of proton pump inhibitors with histamine-2 receptor blockers for ulcer prophylaxis in intensive care patients requiring invasive mechanical intervention.
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 26,797
研究概览
简要总结
- Research question The PEPTIC study compared two types of medicine that are commonly used for preventing stress ulcers in Intensive Care Unit (ICU) patients who require life support, to understand which medicine led to the lowest risk of death, bleeding from the gut), prolonged life support, and Clostridioides difficile infection (a serious infection of the bowel). 2. Background information Patients who require treatment in the Intensive Care Unit (ICU) can develop stomach ulcers which are known as ‘stress ulcers’. ICU patients are routinely given two different types of medicine -proton pump inhibitors (PPI) and histamine H2 receptor blockers (H2RB), to prevent these ulcers, we did not know which treatment was best. This study compared the two most common standard treatments (PPI and H2RB)- in a cluster crossover study (where whole ICUs were randomly assigned to one treatment for 6 months, then swapped over to the other treatment). 3. Participant characteristics Patients from 50 ICUs in Australia, NZ, Canada, Ireland and United Kingdom participated. 13415 patients were assigned to the PPI group and 13356 patients were assigned to the H2RB group. 4. Key results The results found there was no statistically significant difference in mortality (death) 90 days after ICU admission, between the two groups of patients. Gut bleeding was lower in the PPI group of patient and there was no difference between the two groups for Clostridioides difficile infection or prolonged life support. 5. Limitations There was a large amount of cross-over between the 2 treatment arms of the study (PPI in the H2RB arm of the study and H2RB in the PPI arm) and doctors were allowed to use any type of PPI or H2RB and how they gave it. Doctors, nurses and research staff were aware of treatment assignment (unblinded) and individual-level drug data were not assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Prevention
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •All patients aged 18 years or older who are mechanically ventilated within 24 hours of ICU admission.
排除标准
- •Patients who are admitted to ICU with upper GI bleeding (APACHE III admission diagnostic codes 303, 305, and 1403)
研究者
相似试验
终止
4 期
Effectiveness of Two Protocols for Corporal Decolonization in Patients Colonized by Methicillin Resistant Staphylococcus Aureus (MRSA)MRSA - Methicillin Resistant Staphylococcus Aureus InfectionMRSA ColonizationNCT01400308B. Braun Medical SA99
招募中
不适用
Study Comparing SBS and LRTI for Treatment of CMC ArthritisArthritisNCT05111405Fraser Orthopaedic Research Society138
已完成
3 期
Evaluation of Xiaflex: Trial of Effectivenss iN Dupuytren'sDupuytren's DiseaseNCT02725528McMaster University22
已完成
1 期
PK, PD, Safety, and Efficacy of SAIT101 Versus MabThera® Versus Rituxan® in Patients With Rheumatoid ArthritisRheumatoid ArthritisNCT02819726Archigen Biotech Limited294
已完成
不适用
Clinical Performance and Safety Comparison of Stay Safe Link® With Stay Safe® in Patient on CAPD (CAPD-3)Continuous Ambulatory Peritoneal DialysisNCT03177031Penang Hospital, Malaysia472