Fluid administration and fluid overload in the intensive care unit(FLUID-ICU)-an international inception cohort study
概览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Copenhagen University Hospital,Denmark
- 入组人数
- 1,000
- 试验地点
- 3
- 主要终点
- Number of patients with fluid overload
概览
简要总结
Study Title- Fluid administration and fluid overload in the intensive care unit (FLUID-ICU) -an international inception cohort study
What is the study about?
This study looks at how fluids are given to patients in the Intensive Care Unit (ICU) and whether too much fluid (called "fluid overload") can make patients sicker.
Why is this important?
Patients in the ICU often need fluids through an IV to help them stay hydrated and keep their blood pressure stable. But if they get too much fluid, it can cause problems like trouble breathing, kidney issues, and even increase the chance of dying.
What will the researchers do?
Researchers will collect information from many ICUs around the world. They will look at all the fluids given to adult patients who are suddenly admitted to the ICU over a 14-day period. They will gather data from medical records daily until the patient leaves the ICU or for up to 28 days.
What are the goals?
- Primary Goal: To find out how many patients in the ICU get fluid overload.
- Secondary Goals: To see how often fluids are removed from patients, how many days patients have fluid overload, how many days patients live without needing life support, how many days patients are out of the hospital, and the death rate within 90 days of being admitted to the ICU.
How will this help?
By understanding how fluids are managed in the ICU, doctors can improve the way they give fluids to patients. This can help prevent fluid overload and improve patient outcomes, potentially leading to better care practices in the future.
What are the risks?
This study is observational, which means researchers are just watching and recording what happens without changing any treatments. Therefore, it poses no risk or burden to the patients.
Ethical considerations:
The study will follow all ethical guidelines, ensure patient confidentiality, and obtain necessary approvals from ethical committees and authorities in each participating country.
Conclusion:
The findings from this study will provide important information on fluid management in ICUs worldwide and guide future research to improve patient care.
This summary provides an easy-to-understand overview of a complex medical study aimed at improving the care and outcomes of critically ill patients.
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- age more than or equal to 18 years of age 2) Acute admission to the ICU- patients admitted acutely to the participating ICUs due to acute or unexpected critical illness.
排除标准
- •Patients previously included in the FLUID-ICU study 2) Patients with planned ICU admission.
- •Patients with major burns- Patients with acute burn injury of more than 10 percent of the body surface area leading to the present ICU admission.
结局指标
主要结局
Number of patients with fluid overload
时间窗: from study enrollment to ICU discharge or till day 28 whichever will be earlier
次要结局
- Number of patients with fluid overload upon ICU admission-baseline(at the time of ICU admission)
- Number of patients developing fluid overload during the ICU stay(from study enrollment to ICU discharge or till day 28 whichever will be earlier)
- Number of days with fluid overload during the ICU stay(from study enrollment to ICU discharge or till day 28 whichever will be earlier)
- Number of patients being treated with ‘active fluid removal’ such as use of diuretics, or renal replacement therapy(from study enrollment to ICU discharge or till day 28 whichever will be earlier)
- Days alive without life-support within 28 days from ICU admission(till 28 days from ICU admission)
- Days alive and out of hospital within 90 days from ICU admission(till 90 days from the date of ICU admission)
- Mortality within 90 days from ICU admission(till 90 days from the date of ICU admission)
研究者
Dr Sheila N Myatra
Tata Memorial Hospital, Mumbai