Comparison of Two Different External Clearance Markers for Measuring Glomerular Filtration Rate (GFR) - Mannitol and Iohexol, in Patients Treated in the Intensive Care Units and in Outpatients With Chronic Kidney Disease.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Measuring GFR with two different external markers, mannitol as new and iohexol as standard marker
研究概览
简要总结
GFR is the best parameter of the real kidney function. Measurements, however are time-consuming and have limited capacity.
Patients treated in the intensive care units often have more than one organ-insufficiency and acute kidney injury (AKI) has an incidence of up to 70 %. GFR changes dynamically and this is one of the reasons why GFR-measurements have limited indications on the ICU. Retention of medicines or their active metabolites, however can lead to side effects, toxicity and or prolonged ICU-stay. Moreover, patients with allergy to actually standard marker, contrast material iohexol, or gravid patients are not candidate for measuring GFR with iohexol.
In this prospective clinical trial two exogen marker substances will be compared, mannitol as a new marker and iohexol as a standard marker for measuring glomerular filtration rate (GFR). Patients in the intensive care units (ICU) and an outpatient group with stable chronic kidney disease (CKD) are included.
The main question is, how reliable mannitol-GFR is compared to iohexol-GFR in a wide range of kidney insufficiency.
GFR measurements are performed with a bolus injection technique. Patients get mannitol and iohexol bolus at time zero and blood samples are taken three times according to local protocols for iohexol clearance measurements.
详细描述
Written inform consent from the patients or their relatives if they can not communicate.
Inclusion criteria:
Patients with acute or acute on chronic kidney failure (AKI, CKD), who are treated in the intensive care units because of any kind of organ insufficiency are enrolled. Stabil circulatory parameters needed with or without vasoactive drugs. Continuous intravenous administration of fluids and drugs without significant changes during the study period.
Exclusion criteria:
Unstable circulation and need for fluid resuscitation. Known extracellular volume expansion as ascites or peripheral edema. Intravenous paracetamol administration between or during the measurement period. Measurement with iohexol as contrast material during the previous days. Missing inform consent. Allergy to contrast material.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with acute or acute on chronic kidney failure (AKI, CKD) on intensive care units because of any kind of organ insufficiency.
- •Stabile circulatory parameters.
- •CKD-patients in outpatient group
排除标准
- •unstable circulation with need for fluid resuscitation.
- •known extracellular volume expansion as ascites or peripheral edema.
- •Intravenous paracetamol administration between or during the measurement period.
- •measurement with iohexol during the previous days.
- •missing inform consent.
结局指标
主要结局
Measuring GFR with two different external markers, mannitol as new and iohexol as standard marker
时间窗: 12 weeks
Bland-Altman statistic is used for result comparison and Accuracy, P30 and P20 is calculated.
次要结局
未报告次要终点
研究者
Katalin Kiss
consultant anesthesiologist
Sahlgrenska University Hospital