Clinical trial NCT04393493: The Effect in Renal Function on Patients With Type 1 Cardiorenal Syndrome Treated With Two Strategies of Furosemide.
Official title: The Effect in Renal Function on Patients With Type 1 Cardiorenal Syndrome Treated With Two Strategies of Furosemide. A Randomized Controled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cardiorenal Syndrome
Lead sponsor: Hospital Civil de Guadalajara
Sponsor class: OTHER
First posted: 2020-05-19
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Its a randomized, controlled, phase II, 2-arm, double-blind clinical trial
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Number of Participants With Renal Function Recovery Defined as a Return to Individual Baseline Serum Creatinine Values
timeFrame: Up to 96 hours after intervention started
Secondary outcomes:
measure: Change in 24 Hour Urine Output at 96 Hours After Intervention Started From 24 Hour Urine Output One Day Before Intervention Initiation)
timeFrame: 96 hours after intervention started
measure: Change in Serum Creatinine at Day One of Intervention From Serum Creatinine at 96 Hrs After Intervention Started
timeFrame: 96 hours after intervention started
measure: 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
timeFrame: 96 hours after intervention started
measure: In Hospital Mortality Defined as Number of Dead Patients From Day One of Intervention and Before Discharge
timeFrame: From day one of intervention up to discharge, an average of 1 week
measure: Mortality During Follow up Defined as Number of Dead Patients After Discharge
timeFrame: From day one after discharge up to an average of 161 days
measure: Number of Patients With Dyspnea Improvement as Referred by the Patient or Reduction in Supplementary Oxygen Requirements at 96 Hours After Intervention Started
timeFrame: Up to 96 hours after intervention started
measure: Number of Patients With Dyspnea Improvement as Referred by the Patient or Reduction in Supplementary Oxygen Requirements Before Day 3 of Intervention
timeFrame: Up to 3 days after intervention started
measure: Number of Days From the Beginning of the Intervention Until Patients Referred Dyspnea Improvement or a Reduction in Supplementary Oxygen Requirements Was Made.
timeFrame: Up to 4 days after intervention started
measure: Number of Patients That Required Renal Replacement Therapy of Any Type During Intervention (4 Days).
timeFrame: Up to 96 hours after intervention started
Other outcomes:
measure: Change in Serum Copeptin Levels at Day One of Intervention From Serum Copeptin Levels Measured at 96 Hrs After Intervention Started.
timeFrame: 96 hours after intervention started
measure: Change in Serum Brain Natriuretic Peptide Levels at Baseline From Serum Brain Natriuretic Peptide Levels at 96 Hours After Intervention Started
timeFrame: 96 hours after intervention started
measure: Number of Patients That Achieved >30% Reduction in Brain Natriuretic Compared With Baseline Levels
timeFrame: Up to 96 hours after intervention started
measure: Number of Patients Whose Interventions Were Stopped Because Clinical Improvement Was Achieved Before 96 Hours as Assessed by de Clinical Judgement of the Medical Team in Charge.
timeFrame: From the beginning of intervention and before 96 hours after that
measure: Change in Serum Urea Levels Measured at Day One of Intervention From Serum Urea Levels Measured at 96 Hrs After Intervention Started.
timeFrame: 96 hours after intervention started
measure: Change in Serum Sodium Levels Measured at Day One of Intervention From Serum Sodium Levels Measured at 96 Hrs After Intervention Started.
timeFrame: 96 hours after intervention started
measure: Change in Serum Potassium Levels Measured at Day One of Intervention From Serum Potassium Levels Measured at 96 Hrs After Intervention Started.
timeFrame: 96 hours after intervention started
measure: Change in Serum Chloride Levels Measured at Day One of Intervention From Serum Chloride Levels Measured at 96 Hrs After Intervention Started.
timeFrame: 96 hours after intervention started
measure: Change in Serum Magnesium Levels Measured at Day One of Intervention From Serum Magnesium Levels Measured at 96 Hrs After Intervention Started.
timeFrame: 96 hours after intervention started
measure: Change in Serum Calcium Levels Measured at Day One of Intervention From Serum Calcium Levels Measured at 96 Hrs After Intervention Started.
timeFrame: 96 hours after intervention started
measure: Change in Serum pH Value Measured at Day One of Intervention From Serum pH Value Measured at 96 Hrs After Intervention Started.
timeFrame: 96 hours after intervention started
measure: Change in Serum Bicarbonate Levels Measured at Day One of Intervention From Serum Bicarbonate Levels Measured at 96 Hrs After Intervention Started.
timeFrame: 96 hours after intervention started
measure: Change in Serum Partial Pressure of Carbon Dioxide Measured at Day One of Intervention From Serum Partial Pressure of Carbon Dioxide Measured at 96 Hrs After Intervention Started.
timeFrame: 96 hours after intervention started
measure: Change in Serum Lactate Levels Measured at Day One of Intervention From Serum Lactate Levels Measured at 96 Hrs After Intervention Started.
timeFrame: 96 hours after intervention started
Locations:
city: Guadalajara
country: Mexico
facility: HCG
state: Jalisco
city: Guadalajara
country: Mexico
facility: Hospital Civil de Guadalajara
state: Jalisco
Study officials:
References:
citation: Chavez-Iniguez JS, Ibarra-Estrada M, Sanchez-Villaseca S, Romero-Gonzalez G, Font-Yanez JJ, De la Torre-Quiroga A, de Quevedo AA, Romero-Munoz A, Maggiani-Aguilera P, Chavez-Alonso G, Gomez-Fregoso J, Garcia-Garcia G. The Effect in Renal Function and Vascular Decongestion in Type 1 Cardiorenal Syndrome Treated with Two Strategies of Diuretics, a Pilot Randomized Trial. BMC Nephrol. 2022 Jan 3;23(1):3. doi: 10.1186/s12882-021-02637-y.