Hemodynamic resuscitation and monitoring in early sepsis(HERMES Study)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- 1.ICU Mortality
研究概览
简要总结
“Hemodynamic Resuscitation and Monitoring in EarlySepsis (HERMES Study)†involves recording of patient’smedical data related to that has been collected as part of his/her routinemedical care in ICU.
Presentlythere is no data from Indian ICUs on the way patients in early sepsis areresuscitated and monitored. There may exist a wide variation in clinicalpractice. We would like to conduct an observational study in various levels ofIndian ICUs, to prospectively collect data on adult patients admitted to ICUwith early sepsis in a 60-day window period. We would like to study thehemodynamic resuscitation and monitoring performed in these patients. Inaddition, we would like to identify factors associated with improved outcomesand achieving the goals of the sepsis bundles in one, three and six hours.
The objectives of the study are as follows
- To capture the patient characteristics and hemodynamic resuscitation and monitoring practices in patients presenting with early sepsis and hypotension to Indian ICUs
- To determine various factors associated with improved survival in patients with septic shock
- To determine factors associated with achieving the resuscitation goals of the sepsis bundle within1 hour, 3 hours and 6 hours in patients with septic shock
We plan torecruit 50 -100 centers nationwide. Each center will be asked to collect datafrom at least 10 patients in a maximum time window of 60 days. A conveniencesample of minimum 500 patients presenting to ICU with suspected sepsis andhypotension will be taken.
Eachcenter will select a start date anytime between 1 st August to 1st October 2019and will collect data within 60 days of the start date. The study will endanytime between 30th September and 29th November 2019, depending on the startdate. All consecutive patients in the 60-day period will be screened and thoseeligible will be enrolled.
There willbe no direct patient contact or intervention. Local coordinators will guaranteethe integrity of data collection and ensure timely completion of CRFs.
This is an ISCCM Research Committee fundedstudy. The ISCCM will fund the PI institution for all expenses related softwaredevelopment, website hosting, secretarial assistance and miscellaneous expensesrelated to the conduct of the study, data analysis and publication (againstactual bills). No funding will be given to the investigators from the variousparticipating centres for contributing data.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Adult patients (≥ 18 years old)
- •Presenting to ICU with suspected sepsis
- •Presence of hypotension (Systolic BP ≤ 90 mmHg / Mean arterial pressure (MAP) ≤ 65mmhg or patient with Systolic BP > 90 mmHg / MAP >65mmHg on vasopressor.
排除标准
- •Patient likely to be in shock due to reason other than sepsis (e.g. cardiogenic, hemorrhagic shock etc.)
- •Decision taken for not intubating / ventilating /aggressive resuscitation prior to ICU admission
- •Patient transferred from another hospital admitted for more than 7days
- •Patient transferred from another ICU.
结局指标
主要结局
1.ICU Mortality
时间窗: Once after completion of study.
2.Sepsis resuscitation goals achieved in 1 hour
时间窗: Once after completion of study.
次要结局
- Hospital mortality(Once after completion of study.)
- 28-day mortality(Once after completion of study.)
- Sepsis resuscitation goals achieved in 3 hour(Once after completion of study.)
- Sepsis resuscitation goals achieved in 6 hour(Once after completion of study)