The Effect in Renal Function on Patients With Type 1 Cardiorenal Syndrome Treated With Two Strategies of Furosemide.
- Conditions
- Cardiorenal Syndrome
- Interventions
- Registration Number
- NCT04393493
- Lead Sponsor
- Hospital Civil de Guadalajara
- Brief Summary
In double-blind clinical trial, determine renal recovery with two different furosemide strategies in patients with type 1 cardiorenal syndrome.
- Detailed Description
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.
ution + Chlortalidone 50mg VO every 24 hours + Spironolactone 25mg VO every 24 hrs.
With the primary objective of improving renal function measured by serum creatinine, as secondary objectives the efficacy in vascular decongestion and electrolyte alterations.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 80
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description GROUP A Furosemide intravenous solution 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 intravenous solution 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. GROUP B Chlortalidone 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. GROUP B Spironolactone 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.
- Primary Outcome Measures
Name Time Method Number of Participants With Renal Function Recovery Defined as a Return to Individual Baseline Serum Creatinine Values 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)
- Secondary Outcome Measures
Name Time Method Change in Serum Creatinine at Day One of Intervention From Serum Creatinine at 96 Hrs After Intervention Started 96 hours after intervention started Calculated as serum creatinine at day one minus serum creatinine at 96 hrs after intervention started
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 Urine output was collected through an urinary catheter and measured and registered by a nurse. The sum of these registrations from 7 am from one day to 7 am of the next day was considered the 24 hour urinary output
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 Dyspnea improvement was referred by the patient as the clinician asked them "do you feel more or less difficult to breathe?" or if the liters per minute or the fraction of inspired supplementary oxygen necessary to maintain an oxygen saturation \>90% were diminished
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 Dyspnea improvement was referred by the patient as the clinician asked them "do you feel more or less difficult to breathe?" or if the liters per minute or the fraction of inspired supplementary oxygen necessary maintain an oxygen saturation \>90% were diminished
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 Dyspnea improvement was referred by the patient as the clinician asked them "do you feel more or less difficult to breathe?" or if the liters per minute or the fraction of inspired supplementary oxygen necessary maintain an oxygen saturation \>90% were diminished
Number of Patients That Required Renal Replacement Therapy of Any Type During Intervention (4 Days). Up to 96 hours after intervention started The requirement of renal replacement therapy was assessed by the nephrology team in charge
Trial Locations
- Locations (2)
HCG
🇲🇽Guadalajara, Jalisco, Mexico
Hospital Civil de Guadalajara
🇲🇽Guadalajara, Jalisco, Mexico