The Predictive Performance of Renal Ultrasonographic Perfusion Measures on Changes in Renal Clearance in Response to Fluid Therapy.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Changes in renal function in response to a standardised fluid bolus.
研究概览
简要总结
The study will examine the ability of renal ultrasound (Doppler and Contrast Enhanced Ultrasound (CEUS)) in distinguishing ICU patients who exhibit increases in glomerular filtration rate (GFR) in response to fluid loading, from those for whom fluid loading is without benefit of directly harmful.
详细描述
The study will examine the ability of renal ultrasound (Doppler and Contrast Enhanced Ultrasound (CEUS)) in distinguishing ICU patients who exhibit increases in GFR in response to fluid loading, from those for whom fluid loading is without benefit of directly harmful.
Patients available for inclusion will receive a baseline administration of Tc-99-DTPA for precise determination of GFR/renal function by blood and urine samples.
Baseline values of ultrasound measures will be obtained, including renal arterial, renal venous, portal venous and hepatic venous Doppler measures and renal contrast enhanced ultrasound (CEUS) will also be recorded.
After two hours, baseline values of GFR are finished. The patient is then exposed to passive leg raising and ultrasound measures are repeated, including renal arterial, renal venous, portal venous and hepatic venous Doppler measures.
The participant then receives a standardised fluid bolus of 7 ml/kg (ideal body weight) Once the fluid bolus administration is complete, renal ultrasound is repeated, including renal arterial, renal venous, portal venous, hepatic venous Doppler measures and renal CEUS.
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
- •Patients ≥ 18 years admitted to the ICU, Aarhus University Hospital.
- •Patients who are assessed by their attending physician as having need for fluid therapy.
排除标准
- •Insufficient ultrasound imaging of the kidneys.
- •Pregnancy.
- •Intolerance to any ultrasound contrast agent or isotopes, including intolerance for human albumin.
- •Prior enrolment in a conflicting research study.
- •Known morphological kidney disease.
- •Need for dialysis.
- •Need for extracorporeal membrane oxygenation (ECMO).
- •Prior participation.
- •Severe pulmonary hypertension (systolic pulmonary pressure > 90 mmHg)
研究组 & 干预措施
ICU patients
ICU patients who are assessed by their attending physician as having need for fluid therapy and are planned to receive IV crystalloid fluid due to oliguria and/or to improve GFR.
干预措施: IV crystalloid fluid bolus (Drug)
结局指标
主要结局
Changes in renal function in response to a standardised fluid bolus.
时间窗: 6 hours
Renal function is measures as Tc-99-Diethylenetriaminepentaacetic acid (DTPA) clearance.
次要结局
- Renal venous flow classification(6 hours)
- Contrast enhanced ultrasound 5(6 hours)
- Renal venous stasis index(6 hours)
- Renal arterial resistive index(6 hours)
- Contrast enhanced ultrasound 3(6 hours)
- Portal venous pulsatility fraction(6 hours)
- Contrast enhanced ultrasound 1(6 hours)
- Contrast enhanced ultrasound 2(6 hours)
- Renal venous impedance index(6 hours)
- Contrast enhanced ultrasound 4(6 hours)
- Continuous recordings of hemodynamic variables 1(6 hours)
- Continuous recordings of hemodynamic variables 2(6 hours)
研究者
Johan Fridolf Hermansen
Principal Investigator
Aarhus University Hospital