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临床试验/NCT06376461
NCT06376461已完成不适用

Prospective, Multicentre Study to Validate the GastroIntestinal Dysfunction Score (GIDS) and Describe Prevalence, Outcomes, and Management of Phosphate Disorders in Intensive Care Patients

University Hospitals of North Midlands NHS Trust1 个研究点 分布在 1 个国家目标入组 92 人开始时间: 2024年7月26日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
92
试验地点
1
主要终点
28 day outcome

研究概览

简要总结

Part A Multiple organ dysfunction syndrome is one of the main problems in critically ill patients. Several organ dysfunctions are routinely and systematically monitored in patients admitted to intensive care units. Gastrointestinal dysfunction is currently not included in multiple organ dysfunction scores and lacks a standardised approach. At the same time, investigators earlier studies have shown that gastrointestinal dysfunction plays an essential role in the course of illness in intensive care patients. A tool for measuring dysfunction is needed to enable future studies on interventions to improve gastrointestinal function. The GIDS (GastroIntestinal Dysfunction Score) combines different clinical signs and symptoms commonly observed and documented in patients in the ICU into a scoring system, allowing distinguishing between different grades of severity of dysfunction. The investigators will only use observations documented during the patient's stay in the intensive care unit without additional measurements and calculate gastrointestinal (GIDS) and other organ dysfunction scores.

Part B Phosphate is an electrolyte commonly measured and often corrected, while the indications and clear guidance for correction are insufficiently studied. The results of this study will assist in specifying indications for the correction of phosphate levels better and refine the management strategies in the future. Only phosphate levels measured as part of routine care will be documented, no additional samples for study purposes will be taken, and the study will not influence the treatment of phosphate disorders.

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

入选标准

  • Admission to ICU during the study period (the patients already in the ICU at the time the study starts will not be included);
  • Age ≥18 years;
  • In participating centres in part B, serum Pi should be measured daily.

排除标准

  • Age <18 years;
  • Patients with restrictions of care such as "no intubation" or "no RRT" 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

28 day outcome

时间窗: 28 days after ICU admission

28 day all cause mortality

90 day outcome

时间窗: 90 days after ICU admission

90 day all cause mortality

次要结局

  • Hospital length of stay(90 days after admission)
  • ICU length of stay(90 days after admission to ICU)
  • Free of organ support(28 days after admission)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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