GRIP-COMPASS Trial: Computer-driven Glucose and Potassium Regulation Program in Intensive Care Patients With COMparison of PotASSium Targets Within normokAlemic Range
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 1,225
- 试验地点
- 1
- 主要终点
- AFib or AFl in patients who underwent CABG (coronary artery bypass grafting) or valvular surgery.
研究概览
简要总结
Rationale: It is well known that distinctly abnormal blood potassium values can cause serious complications such as cardiac arrhythmias. Although potassium regulation is generally considered important, hardly any research has been done about potassium regulation in intensive care patients. The investigators hypothesize that different potassium target-values, within the as normal accepted range, may have different effects in critically ill patients.
Study design: A prospective trial comparing two different potassium target-values. Potassium will be tightly regulated with the already fully operational GRIP-II computer program.
Study population: 1200 adult patients admitted at the thoracic intensive care unit of the University Medical Center Groningen.
Intervention: Comparison between two variations of standard therapy: potassium target-value of 4.0 mmol/L versus 4.5 mmol/L.
Main study parameters/endpoints: The primary endpoint is the incidence of atrial fibrillation or atrial flutter from ICU-admission to hospital discharge. Secondary endpoints are serum levels of potassium and the other main electrolytes, renal function and renal potassium excretion, the relation with insulin and glucose, the cumulative fluid balance, (ICU) length of stay and mortality.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All adult patients admitted to the thoracic and surgical ICU of the University Medical Center Groningen.
- •Computerized potassium regulation with GRIP-II
排除标准
- •Patients who are not potassium regulated with GRIP-II (patients who take their own meals).
研究组 & 干预措施
Normal-high potassium (NHP)
A potassium target of 4.5 mmol/L.
干预措施: Potassium Chloride (Drug)
Normal-low potassium (NLP)
A potassium target of 4.0 mmol/L.
干预措施: Potassium Chloride (Drug)
结局指标
主要结局
AFib or AFl in patients who underwent CABG (coronary artery bypass grafting) or valvular surgery.
时间窗: First 7d after Intensive Care Unit admission or hospital discharge, whichever is earlier.
Post-surgery AFib and AFl typically occur within days after surgery. AFib and AFl can only be reliably assessed during ICU stay and hospital stay. Therefore this outcome measure is not determined after hospital discharge.
次要结局
- Potassium regulation within 3.5 to 5.0 mmol/L.(From Intensive Care Unit admission to hospital discharge.)
- AFib or AFl in other patients, i.e. patients who did not undergo CABG or valvular surgery.(First 7d after ICU-admission or hospital discharge, whichever is earlier.)
- Biochemical disturbances including electrolytes (Na, K, Mg, Ca), blood gas analysis, lactate, renal function (creatinine, urea).(From ICU-admission to hospital discharge.)
- Cumulative fluid balance.(During ICU-stay.)
- Mortality and (ICU) length of stay.(ICU-mortality and hospital-mortality as well as 90-day mortality.)
- Glucose regulation(During ICU-admission.)
研究者
Miriam Hoekstra
MD
University Medical Center Groningen