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Completed

NCT Number: NCT04393493

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

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

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Key information

Conditions

Cardiorenal Syndrome Cardio-Renal Syndrome Cardiovascular Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Heart Diseases Heart Failure Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

HCG, Guadalajara, Jalisco, Mexico

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Furosemide intravenous solution

Drug

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

Drug

One 50 mg pill administrated every 24 hours in group B

Spironolactone

Drug

One 50 mg pill administrated every 24 hours in group B

Primary outcomes

  1. Number of Participants With Renal Function Recovery Defined as a Return to Individual Baseline Serum Creatinine Values

    Time frame: 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 outcomes

  1. Change in 24 Hour Urine Output at 96 Hours After Intervention Started From 24 Hour Urine Output One Day Before Intervention Initiation)

    Time frame: 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

  2. Change in Serum Creatinine at Day One of Intervention From Serum Creatinine at 96 Hrs After Intervention Started

    Time frame: 96 hours after intervention started

    Calculated as serum creatinine at day one minus serum creatinine at 96 hrs after intervention started

  3. 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

  4. 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

  5. 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

  6. Number of Patients With Dyspnea Improvement as Referred by the Patient or Reduction in Supplementary Oxygen Requirements at 96 Hours After Intervention Started

    Time frame: 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

  7. Number of Patients With Dyspnea Improvement as Referred by the Patient or Reduction in Supplementary Oxygen Requirements Before Day 3 of Intervention

    Time frame: 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

  8. Number of Days From the Beginning of the Intervention Until Patients Referred Dyspnea Improvement or a Reduction in Supplementary Oxygen Requirements Was Made.

    Time frame: 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

  9. Number of Patients That Required Renal Replacement Therapy of Any Type During Intervention (4 Days).

    Time frame: Up to 96 hours after intervention started

    The requirement of renal replacement therapy was assessed by the nephrology team in charge

Other outcomes

  1. Change in Serum Copeptin Levels at Day One of Intervention From Serum Copeptin Levels Measured at 96 Hrs After Intervention Started.

    Time frame: 96 hours after intervention started

    Calculated as serum copeptin levels at day one minus serum copeptin levels measured at 96 hrs after intervention started

  2. Change in Serum Brain Natriuretic Peptide Levels at Baseline From Serum Brain Natriuretic Peptide Levels at 96 Hours After Intervention Started

    Time frame: 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

  3. Number of Patients That Achieved >30% Reduction in Brain Natriuretic Compared With Baseline Levels

    Time frame: Up to 96 hours after intervention started

    Baseline levels were defined as the measurement at hospital admission

  4. 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.

    Time frame: From the beginning of intervention and before 96 hours after that

    Clinical improvement was referred as remission of symptoms with achievement of 24 hour urine output equal or greater than 3000 milliliters

  5. Change in Serum Urea Levels Measured at Day One of Intervention From Serum Urea Levels Measured at 96 Hrs After Intervention Started.

    Time frame: 96 hours after intervention started

    Calculated as serum urea levels at day one of intervention minus serum urea levels at 96 hrs after intervention started.

  6. Change in Serum Sodium Levels Measured at Day One of Intervention From Serum Sodium Levels Measured at 96 Hrs After Intervention Started.

    Time frame: 96 hours after intervention started

    Calculated as serum sodium levels at day one of intervention minus serum sodium levels at 96 hrs after intervention started.

  7. Change in Serum Potassium Levels Measured at Day One of Intervention From Serum Potassium Levels Measured at 96 Hrs After Intervention Started.

    Time frame: 96 hours after intervention started

    Calculated as serum potassium levels at day one of intervention minus serum potassium levels at 96 hrs after intervention started.

  8. Change in Serum Chloride Levels Measured at Day One of Intervention From Serum Chloride Levels Measured at 96 Hrs After Intervention Started.

    Time frame: 96 hours after intervention started

    Calculated as serum chloride levels at day one of intervention minus serum chloride levels at 96 hrs after intervention started.

  9. Change in Serum Magnesium Levels Measured at Day One of Intervention From Serum Magnesium Levels Measured at 96 Hrs After Intervention Started.

    Time frame: 96 hours after intervention started

    Calculated as serum magnesium levels at day one of intervention minus serum magnesium levels at 96 hrs after intervention started.

  10. Change in Serum Calcium Levels Measured at Day One of Intervention From Serum Calcium Levels Measured at 96 Hrs After Intervention Started.

    Time frame: 96 hours after intervention started

    Calculated as serum calcium levels at day one of intervention minus serum calcium levels at 96 hrs after intervention started.

  11. Change in Serum pH Value Measured at Day One of Intervention From Serum pH Value Measured at 96 Hrs After Intervention Started.

    Time frame: 96 hours after intervention started

    Calculated as serum pH value at day one of intervention minus serum pH value at 96 hrs after intervention started.

  12. Change in Serum Bicarbonate Levels Measured at Day One of Intervention From Serum Bicarbonate Levels Measured at 96 Hrs After Intervention Started.

    Time frame: 96 hours after intervention started

    Calculated as serum bicarbonate levels at day one of intervention minus bicarbonate levels at 96 hrs after intervention started.

  13. 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.

    Time frame: 96 hours 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.

  14. Change in Serum Lactate Levels Measured at Day One of Intervention From Serum Lactate Levels Measured at 96 Hrs After Intervention Started.

    Time frame: 96 hours after intervention started

    Calculated as serum lactate levels at day one of intervention minus serum lactate levels at 96 hrs after intervention started.

Sponsors and collaborators

Lead sponsor

Hospital Civil de Guadalajara

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
May 19, 2020
Registry last updated
Sep 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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