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

Primary Purpose

Cardiorenal Syndrome

Status
Completed
Phase
Phase 2
Locations
Mexico
Study Type
Interventional
Intervention
Furosemide intravenous solution
Chlortalidone
Spironolactone
Sponsored by
Hospital Civil de Guadalajara
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiorenal Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • HCG
  • Hospital Civil de Guadalajara

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

GROUP A

GROUP B

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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
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
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
In Hospital Mortality Defined as Number of Dead Patients From Day One of Intervention and Before Discharge
Mortality During Follow up Defined as Number of Dead Patients After Discharge
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
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
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
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

Full Information

First Posted
August 22, 2017
Last Updated
August 21, 2020
Sponsor
Hospital Civil de Guadalajara
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1. Study Identification

Unique Protocol Identification Number
NCT04393493
Brief Title
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

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
July 1, 2017 (Actual)
Primary Completion Date
April 1, 2020 (Actual)
Study Completion Date
April 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Civil de Guadalajara

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiorenal Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Its a randomized, controlled, phase II, 2-arm, double-blind clinical trial
Masking
ParticipantInvestigator
Masking Description
Double-blind clinical trial
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GROUP A
Arm Type
Experimental
Arm Description
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
Arm Title
GROUP B
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Furosemide intravenous solution
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Chlortalidone
Intervention Description
One 50 mg pill administrated every 24 hours in group B
Intervention Type
Drug
Intervention Name(s)
Spironolactone
Intervention Description
One 50 mg pill administrated every 24 hours in group B
Primary Outcome Measure Information:
Title
Number of Participants With Renal Function Recovery Defined as a Return to Individual Baseline Serum Creatinine Values
Description
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)
Time Frame
Up to 96 hours after intervention started
Secondary Outcome Measure Information:
Title
Change in 24 Hour Urine Output at 96 Hours After Intervention Started From 24 Hour Urine Output One Day Before Intervention Initiation)
Description
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
Time Frame
96 hours after intervention started
Title
Change in Serum Creatinine at Day One of Intervention From Serum Creatinine at 96 Hrs After Intervention Started
Description
Calculated as serum creatinine at day one minus serum creatinine at 96 hrs after intervention started
Time Frame
96 hours after intervention started
Title
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
Time Frame
96 hours after intervention started
Title
In Hospital Mortality Defined as Number of Dead Patients From Day One of Intervention and Before Discharge
Time Frame
From day one of intervention up to discharge, an average of 1 week
Title
Mortality During Follow up Defined as Number of Dead Patients After Discharge
Time Frame
From day one after discharge up to an average of 161 days
Title
Number of Patients With Dyspnea Improvement as Referred by the Patient or Reduction in Supplementary Oxygen Requirements at 96 Hours After Intervention Started
Description
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
Time Frame
Up to 96 hours after intervention started
Title
Number of Patients With Dyspnea Improvement as Referred by the Patient or Reduction in Supplementary Oxygen Requirements Before Day 3 of Intervention
Description
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
Time Frame
Up to 3 days after intervention started
Title
Number of Days From the Beginning of the Intervention Until Patients Referred Dyspnea Improvement or a Reduction in Supplementary Oxygen Requirements Was Made.
Description
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
Time Frame
Up to 4 days after intervention started
Title
Number of Patients That Required Renal Replacement Therapy of Any Type During Intervention (4 Days).
Description
The requirement of renal replacement therapy was assessed by the nephrology team in charge
Time Frame
Up to 96 hours after intervention started
Other Pre-specified Outcome Measures:
Title
Change in Serum Copeptin Levels at Day One of Intervention From Serum Copeptin Levels Measured at 96 Hrs After Intervention Started.
Description
Calculated as serum copeptin levels at day one minus serum copeptin levels measured at 96 hrs after intervention started
Time Frame
96 hours after intervention started
Title
Change in Serum Brain Natriuretic Peptide Levels at Baseline From Serum Brain Natriuretic Peptide Levels at 96 Hours After Intervention Started
Description
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
Time Frame
96 hours after intervention started
Title
Number of Patients That Achieved >30% Reduction in Brain Natriuretic Compared With Baseline Levels
Description
Baseline levels were defined as the measurement at hospital admission
Time Frame
Up to 96 hours after intervention started
Title
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.
Description
Clinical improvement was referred as remission of symptoms with achievement of 24 hour urine output equal or greater than 3000 milliliters
Time Frame
From the beginning of intervention and before 96 hours after that
Title
Change in Serum Urea Levels Measured at Day One of Intervention From Serum Urea Levels Measured at 96 Hrs After Intervention Started.
Description
Calculated as serum urea levels at day one of intervention minus serum urea levels at 96 hrs after intervention started.
Time Frame
96 hours after intervention started
Title
Change in Serum Sodium Levels Measured at Day One of Intervention From Serum Sodium Levels Measured at 96 Hrs After Intervention Started.
Description
Calculated as serum sodium levels at day one of intervention minus serum sodium levels at 96 hrs after intervention started.
Time Frame
96 hours after intervention started
Title
Change in Serum Potassium Levels Measured at Day One of Intervention From Serum Potassium Levels Measured at 96 Hrs After Intervention Started.
Description
Calculated as serum potassium levels at day one of intervention minus serum potassium levels at 96 hrs after intervention started.
Time Frame
96 hours after intervention started
Title
Change in Serum Chloride Levels Measured at Day One of Intervention From Serum Chloride Levels Measured at 96 Hrs After Intervention Started.
Description
Calculated as serum chloride levels at day one of intervention minus serum chloride levels at 96 hrs after intervention started.
Time Frame
96 hours after intervention started
Title
Change in Serum Magnesium Levels Measured at Day One of Intervention From Serum Magnesium Levels Measured at 96 Hrs After Intervention Started.
Description
Calculated as serum magnesium levels at day one of intervention minus serum magnesium levels at 96 hrs after intervention started.
Time Frame
96 hours after intervention started
Title
Change in Serum Calcium Levels Measured at Day One of Intervention From Serum Calcium Levels Measured at 96 Hrs After Intervention Started.
Description
Calculated as serum calcium levels at day one of intervention minus serum calcium levels at 96 hrs after intervention started.
Time Frame
96 hours after intervention started
Title
Change in Serum pH Value Measured at Day One of Intervention From Serum pH Value Measured at 96 Hrs After Intervention Started.
Description
Calculated as serum pH value at day one of intervention minus serum pH value at 96 hrs after intervention started.
Time Frame
96 hours after intervention started
Title
Change in Serum Bicarbonate Levels Measured at Day One of Intervention From Serum Bicarbonate Levels Measured at 96 Hrs After Intervention Started.
Description
Calculated as serum bicarbonate levels at day one of intervention minus bicarbonate levels at 96 hrs after intervention started.
Time Frame
96 hours after intervention started
Title
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.
Description
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.
Time Frame
96 hours after intervention started
Title
Change in Serum Lactate Levels Measured at Day One of Intervention From Serum Lactate Levels Measured at 96 Hrs After Intervention Started.
Description
Calculated as serum lactate levels at day one of intervention minus serum lactate levels at 96 hrs after intervention started.
Time Frame
96 hours after intervention started

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
HCG
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44240
Country
Mexico
Facility Name
Hospital Civil de Guadalajara
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44240
Country
Mexico

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34979962
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.
Results Reference
derived

Learn more about this trial

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

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