The Effect in Renal Function on Patients With Type 1 Cardiorenal Syndrome Treated With Two Strategies of Furosemide.

Cardiorenal Syndrome Clinical Trial

Official title:

The Effect in Renal Function on Patients With Type 1 Cardiorenal Syndrome Treated With Two Strategies of Furosemide. A Randomized Controled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04393493
• Other study ID #: 112/17
• Status: Completed
• Phase: Phase 2
• Start date: July 1, 2017
• Est. completion date: April 1, 2020

Study information

• Verified date: August 2020
• Source: Hospital Civil de Guadalajara
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In double-blind clinical trial, determine renal recovery with two different furosemide strategies in patients with type 1 cardiorenal syndrome.

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 information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: April 1, 2020
• Est. primary completion date: April 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardio-Renal Syndrome
• Cardiorenal Syndrome
• Syndrome

Intervention

Drug:
• Furosemide intravenous solution
Administrated as an 80 mg intravenous bolus every 24 hours in both arms and then as a continuous infusion dosed according to the experimental arm.
• Chlortalidone
One 50 mg pill administrated every 24 hours in group B
• Spironolactone
One 50 mg pill administrated every 24 hours in group B

Locations

Country	Name	City	State
Mexico	HCG	Guadalajara	Jalisco
Mexico	Hospital Civil de Guadalajara	Guadalajara	Jalisco

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Civil de Guadalajara

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Serum Copeptin Levels at Day One of Intervention From Serum Copeptin Levels Measured at 96 Hrs After Intervention Started.	Calculated as serum copeptin levels at day one minus serum copeptin levels measured at 96 hrs after intervention started	96 hours after intervention started
Other	Change in Serum Brain Natriuretic Peptide Levels at Baseline From Serum Brain Natriuretic Peptide Levels at 96 Hours After Intervention Started	Baseline levels were defined as the measurement at hospital admission. Calculated as serum brain natriuretic peptide levels at baseline minus serum brain natriuretic peptide levels at 96 hours after intervention started	96 hours after intervention started
Other	Number of Patients That Achieved >30% Reduction in Brain Natriuretic Compared With Baseline Levels	Baseline levels were defined as the measurement at hospital admission	Up to 96 hours after intervention started
Other	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.	Clinical improvement was referred as remission of symptoms with achievement of 24 hour urine output equal or greater than 3000 milliliters	From the beginning of intervention and before 96 hours after that
Other	Change in Serum Urea Levels Measured at Day One of Intervention From Serum Urea Levels Measured at 96 Hrs After Intervention Started.	Calculated as serum urea levels at day one of intervention minus serum urea levels at 96 hrs after intervention started.	96 hours after intervention started
Other	Change in Serum Sodium Levels Measured at Day One of Intervention From Serum Sodium Levels Measured at 96 Hrs After Intervention Started.	Calculated as serum sodium levels at day one of intervention minus serum sodium levels at 96 hrs after intervention started.	96 hours after intervention started
Other	Change in Serum Potassium Levels Measured at Day One of Intervention From Serum Potassium Levels Measured at 96 Hrs After Intervention Started.	Calculated as serum potassium levels at day one of intervention minus serum potassium levels at 96 hrs after intervention started.	96 hours after intervention started
Other	Change in Serum Chloride Levels Measured at Day One of Intervention From Serum Chloride Levels Measured at 96 Hrs After Intervention Started.	Calculated as serum chloride levels at day one of intervention minus serum chloride levels at 96 hrs after intervention started.	96 hours after intervention started
Other	Change in Serum Magnesium Levels Measured at Day One of Intervention From Serum Magnesium Levels Measured at 96 Hrs After Intervention Started.	Calculated as serum magnesium levels at day one of intervention minus serum magnesium levels at 96 hrs after intervention started.	96 hours after intervention started
Other	Change in Serum Calcium Levels Measured at Day One of Intervention From Serum Calcium Levels Measured at 96 Hrs After Intervention Started.	Calculated as serum calcium levels at day one of intervention minus serum calcium levels at 96 hrs after intervention started.	96 hours after intervention started
Other	Change in Serum pH Value Measured at Day One of Intervention From Serum pH Value Measured at 96 Hrs After Intervention Started.	Calculated as serum pH value at day one of intervention minus serum pH value at 96 hrs after intervention started.	96 hours after intervention started
Other	Change in Serum Bicarbonate Levels Measured at Day One of Intervention From Serum Bicarbonate Levels Measured at 96 Hrs After Intervention Started.	Calculated as serum bicarbonate levels at day one of intervention minus bicarbonate levels at 96 hrs after intervention started.	96 hours after intervention started
Other	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.	Calculated as serum partial pressure of carbon dioxide at day one of intervention minus serum partial pressure of carbon dioxide at 96 hrs after intervention started.	96 hours after intervention started
Other	Change in Serum Lactate Levels Measured at Day One of Intervention From Serum Lactate Levels Measured at 96 Hrs After Intervention Started.	Calculated as serum lactate levels at day one of intervention minus serum lactate levels at 96 hrs after intervention started.	96 hours after intervention started
Primary	Number of Participants With Renal Function Recovery Defined as a Return to Individual Baseline Serum Creatinine Values	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)	Up to 96 hours after intervention started
Secondary	Change in 24 Hour Urine Output at 96 Hours After Intervention Started From 24 Hour Urine Output One Day Before Intervention Initiation)	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	96 hours after intervention started
Secondary	Change in Serum Creatinine at Day One of Intervention From Serum Creatinine at 96 Hrs After Intervention Started	Calculated as serum creatinine at day one minus serum creatinine at 96 hrs after intervention started	96 hours after intervention started
Secondary	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
Secondary	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
Secondary	Mortality During Follow up Defined as Number of Dead Patients After Discharge		From day one after discharge up to an average of 161 days
Secondary	Number of Patients With Dyspnea Improvement as Referred by the Patient or Reduction in Supplementary Oxygen Requirements at 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	Up to 96 hours after intervention started
Secondary	Number of Patients With Dyspnea Improvement as Referred by the Patient or Reduction in Supplementary Oxygen Requirements Before Day 3 of Intervention	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	Up to 3 days after intervention started
Secondary	Number of Days From the Beginning of the Intervention Until Patients Referred Dyspnea Improvement or a Reduction in Supplementary Oxygen Requirements Was Made.	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	Up to 4 days after intervention started
Secondary	Number of Patients That Required Renal Replacement Therapy of Any Type During Intervention (4 Days).	The requirement of renal replacement therapy was assessed by the nephrology team in charge	Up to 96 hours after intervention started