NCT04393493已完成2 期
The Effect in Renal Function on Patients With Type 1 Cardiorenal Syndrome Treated With Two Strategies of Furosemide. A Randomized Controled Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Number of Participants With Renal Function Recovery Defined as a Return to Individual Baseline Serum Creatinine Values
研究概览
简要总结
In double-blind clinical trial, determine renal recovery with two different furosemide strategies in patients with type 1 cardiorenal syndrome.
详细描述
In a patient with type 1 cardiorenal syndrome, we tried to compare two Furosemide strategies: both with a morning bolus, and randomized in two groups:
Group A: Furosemide 80 mg every 24 hrs (morning) intravenously every 24 hrs for 4 consecutive days, additionally:
- Day 1 furosemide 100mg / day infused with 100cc of Hartmann solution
- Day 2 Furosemide 200mg / day infused with 100cc of Hartmann solution
- Day 3 Furosemide 300mg / day infused with 100cc of Hartmann solution
- Day 4 Furosemide 400mg / day infused with 100cc of Hartmann solution
Group B: Furosemide 80 mg every 24 hrs (morning) intravenously every 24 hrs for 4 consecutive days, additionally:
- Day 1 furosemide 100mg / day infused with 100cc of Hartmann solution + Chlortalidone 50mg VO every 24 hours + Spironolactone 50mg VO every 24 hrs.
- Day 2 furosemide 100mg / day infused with 100cc of Hartmann solution + Chlortalidone 50mg VO every 24 hours + Spironolactone 50mg VO every 24 hrs.
- Day 3 furosemide 100mg / day infused with 100cc of Hartmann solution + Chlortalidone 50mg VO every 24 hours + Spironolactone 50mg VO every 24 hrs.
- Day 4 furosemide 100mg / day infused with 100cc of Hartmann solution + Chlortalidone 50mg VO every 24 hours + Spironolactone 50mg VO every 24 hrs.
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
- Double (Participant, Investigator)
盲法说明
Double-blind clinical trial
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
- •Comply with both clinical diagnosis of acute kidney injury by serum creatinine according to the Kidney Disease Improving Global Outcomes (KDIGO) 2012 guidelines and acute decompensate heart failure as clinical assessed by the clinical team in charge.
- •Have agreed and signed informed consent
排除标准
- •Patient in chronic dialysis either peritoneal dialysis or hemodialysis.
- •History of being a renal transplant recipient
- •History of acute kidney injury according to the KDIGO 2012 guidelines and / or renal replacement therapy in the last 3 months
- •Pregnancy
- •Impossibility to administer medication by the oral route
研究组 & 干预措施
GROUP A
Experimental
Furosemide 80 mg every 24 hrs (morning) intravenously every 24 hrs for 4 consecutive days, additionally:
- Day 1 furosemide 100mg / day infused with 100cc of Hartmann solution
- Day 2 Furosemide 200mg / day infused with 100cc of Hartmann solution
- Day 3 Furosemide 300mg / day infused with 100cc of Hartmann solution
- Day 4 Furosemide 400mg / day infused with 100cc of Hartmann solution
干预措施: Furosemide intravenous solution (Drug)
GROUP B
Experimental
Furosemide 80 mg every 24 hrs (morning) intravenously every 24 hrs for 4 consecutive days, additionally:
- Day 1 furosemide 100mg / day infused with 100cc of Hartmann solution + Chlortalidone 50mg VO every 24 hours + Spironolactone 50mg VO every 24 hrs.
- Day 2 furosemide 100mg / day infused with 100cc of Hartmann solution + Chlortalidone 50mg VO every 24 hours + Spironolactone 50mg VO every 24 hrs.
- Day 3 furosemide 100mg / day infused with 100cc of Hartmann solution + Chlortalidone 50mg VO every 24 hours + Spironolactone 50mg VO every 24 hrs.
- Day 3 furosemide 100mg / day infused with 100cc of Hartmann solution + Chlortalidone 50mg VO every 24 hours + Spironolactone 50mg VO every 24 hrs.
干预措施: Furosemide intravenous solution (Drug)
GROUP B
Experimental
Furosemide 80 mg every 24 hrs (morning) intravenously every 24 hrs for 4 consecutive days, additionally:
- Day 1 furosemide 100mg / day infused with 100cc of Hartmann solution + Chlortalidone 50mg VO every 24 hours + Spironolactone 50mg VO every 24 hrs.
- Day 2 furosemide 100mg / day infused with 100cc of Hartmann solution + Chlortalidone 50mg VO every 24 hours + Spironolactone 50mg VO every 24 hrs.
- Day 3 furosemide 100mg / day infused with 100cc of Hartmann solution + Chlortalidone 50mg VO every 24 hours + Spironolactone 50mg VO every 24 hrs.
- Day 3 furosemide 100mg / day infused with 100cc of Hartmann solution + Chlortalidone 50mg VO every 24 hours + Spironolactone 50mg VO every 24 hrs.
干预措施: Chlortalidone (Drug)
GROUP B
Experimental
Furosemide 80 mg every 24 hrs (morning) intravenously every 24 hrs for 4 consecutive days, additionally:
- Day 1 furosemide 100mg / day infused with 100cc of Hartmann solution + Chlortalidone 50mg VO every 24 hours + Spironolactone 50mg VO every 24 hrs.
- Day 2 furosemide 100mg / day infused with 100cc of Hartmann solution + Chlortalidone 50mg VO every 24 hours + Spironolactone 50mg VO every 24 hrs.
- Day 3 furosemide 100mg / day infused with 100cc of Hartmann solution + Chlortalidone 50mg VO every 24 hours + Spironolactone 50mg VO every 24 hrs.
- Day 3 furosemide 100mg / day infused with 100cc of Hartmann solution + Chlortalidone 50mg VO every 24 hours + Spironolactone 50mg VO every 24 hrs.
干预措施: Spironolactone (Drug)
结局指标
主要结局
Number of Participants With Renal Function Recovery Defined as a Return to Individual Baseline Serum Creatinine Values
时间窗: Up to 96 hours after intervention started
Comparing patient's baseline serum creatinine (previous serum creatinine of 3 months ago and up to a year ago) with creatinine measurements every 24 hours during intervention (4 days)
次要结局
- Change in 24 Hour Urine Output at 96 Hours After Intervention Started From 24 Hour Urine Output One Day Before Intervention Initiation)(96 hours after intervention started)
- Change in Serum Creatinine at Day One of Intervention From Serum Creatinine at 96 Hrs After Intervention Started(96 hours after intervention started)
- An Elevation of at Least 0.3 mg/dl of Serum Creatinine From Day One of Intervention Compared With Serum Creatinine at 96hrs After Intervention Started(96 hours after intervention started)
- In Hospital Mortality Defined as Number of Dead Patients From Day One of Intervention and Before Discharge(From day one of intervention up to discharge, an average of 1 week)
- Mortality During Follow up Defined as Number of Dead Patients After Discharge(From day one after discharge up to an average of 161 days)
- Number of Patients With Dyspnea Improvement as Referred by the Patient or Reduction in Supplementary Oxygen Requirements at 96 Hours After Intervention Started(Up to 96 hours after intervention started)
- Number of Patients With Dyspnea Improvement as Referred by the Patient or Reduction in Supplementary Oxygen Requirements Before Day 3 of Intervention(Up to 3 days after intervention started)
- Number of Days From the Beginning of the Intervention Until Patients Referred Dyspnea Improvement or a Reduction in Supplementary Oxygen Requirements Was Made.(Up to 4 days after intervention started)
- Number of Patients That Required Renal Replacement Therapy of Any Type During Intervention (4 Days).(Up to 96 hours after intervention started)
研究者
Jonathan Samuel Chavez Iñiguez
MD
Hospital Civil de Guadalajara
研究点 (2)
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