Prospective, Multicentre Study to Validate the GastroIntestinal Dysfunction Score (GIDS) and Describe Prevalence, Outcomes, and Management of Phosphate Disorders in Intensive Care Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,681
- 试验地点
- 1
- 主要终点
- 90 days mortality
研究概览
简要总结
This study will address two specific research questions simultaneously:
- validation of the GastroIntestinal (GI) Dysfunction score (GIDS).
- description of epidemiology, risk factors, and management of phosphate disorders.
The aim is to recruit 20 ICUs and 1500 ICU patients. Sites will recruit all consecutive adult patients to a maximum of 120 patients or a maximum recruitment period of 8 weeks, whichever comes first. Daily data collection on gastrointestinal signs and symptoms as well as phosphate values and management will be collected during ICU stay for maximum of 7 days. 28 and 90 day mortality and days free of organ support will be the main outcomes. Secondary outcomes include prevalence of hypo- and hyperphosphatemia and description of their management.
详细描述
Patient population All consecutive adult patients that are admitted to participating ICU during a recruitment period of maximum 8 weeks.
Duration of the study for the individual patient:
- Study period of a maximum of 7 days
- Follow-up period of a maximum of 90 days All patients will be included in the Part A of the study validating GIDS, patients from sites with routine serum phosphate measurements will be included also in the Part B of the study where additional data on serum phosphate levels and management of phosphate disorders will be collected. There will be no additional measurements due to study participation, daily routine is documented.
Baseline characteristics will be collected at ICU admission/study inclusion Daily data include routine data on organ dysfunctions and organ support therapies and specific data on phosphate where available.
Outcome data include 28 and 90 days mortality, and days free of organ support by day 28.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Admission to ICU during the study period
- •Age ≥18 years
排除标准
- •Age <18 years;
- •Patients with restrictions of care such as "no intubation" or "no renal replacement therapy" on ICU admission and patients admitted for treatment as organ donors;
- •Continuous chronic home ventilation for neuromuscular disease;
- •Declined participation or informed consent (if the local ethics committee requests the latter for this non-interventional study);
- •Readmission to ICU during the study period
结局指标
主要结局
90 days mortality
时间窗: 90 days
Survival status at 90 days after ICU admission
28 days mortality
时间窗: 28 days
Survival status at 28 days after ICU admission
次要结局
- Incidence of phosphate disorders during seven days of ICU stay(7 days)
- Days free of organ support(28 days)
- The amount of phosphate administered(7 days)
- Change in serum phosphate level in response to phosphate supplementation(7 days)
- Prevalence of phosphate disorders at ICU admission(Day of ICU admission (day 1))
研究者
Annika Reintam Blaser
Associate Professor
University of Tartu