A Phase 2 interventional study of Furosemide intravenous solution and Chlortalidone in Cardiorenal Syndrome, sponsored by Hospital Civil de Guadalajara. Completed at 2 sites in Mexico. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-09-14.
Sponsored by Hospital Civil de Guadalajara · Phase 2, Interventional, and Treatment
In double-blind clinical trial, determine renal recovery with two different furosemide strategies in patients with type 1 cardiorenal syndrome.
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:
Group B: Furosemide 80 mg every 24 hrs (morning) intravenously every 24 hrs for 4 consecutive days, additionally:
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.
76 studies on the registry are indexed under Cardio-Renal Syndrome; 22 are open to participants now.
This study's enrollment of 80 is above the median of 60 across 46 interventional studies indexed under Cardio-Renal Syndrome.
Browse Cardio-Renal Syndrome studies →Hospital Civil de Guadalajara is the lead sponsor of 39 studies on the registry; 11 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Drug: 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.
Drug: Furosemide intravenous solution · Drug: Chlortalidone · Drug: Spironolactone
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.
One 50 mg pill administrated every 24 hours in group B
One 50 mg pill administrated every 24 hours in group B
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)
Time frame: Up to 96 hours 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)
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
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
Time frame: 96 hours 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
Time frame: 96 hours after intervention started
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
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
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
Time frame: Up to 96 hours after intervention started
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
Time frame: Up to 3 days after intervention started
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
Time frame: Up to 4 days after intervention started
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
Time frame: Up to 96 hours after intervention started
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
Time frame: 96 hours after intervention started
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
Time frame: 96 hours after intervention started
Number of Patients That Achieved >30% Reduction in Brain Natriuretic Compared With Baseline Levels
Baseline levels were defined as the measurement at hospital admission
Time frame: Up to 96 hours after intervention started
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
Time frame: From the beginning of intervention and before 96 hours after that
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.
Time frame: 96 hours after intervention started
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.
Time frame: 96 hours after intervention started
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.
Time frame: 96 hours after intervention started
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.
Time frame: 96 hours after intervention started
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.
Time frame: 96 hours after intervention started
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.
Time frame: 96 hours after intervention started
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.
Time frame: 96 hours after intervention started
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.
Time frame: 96 hours after intervention started
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.
Time frame: 96 hours after intervention started
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.
Time frame: 96 hours after intervention started
We screened all consecutive patients admitted for acute decompensated heart failure (ADHF) and acute kidney injury (AKI) who were evaluated by the Nephrology service at the Hospital Civil de Guadalajara Fray Antonio Alcalde, an University Hospital, from July 2017 to February 2020.
| Milestone | Stepped Furosemide | Diuretics Combined |
|---|---|---|
| Started | 40 | 40 |
| Completed | 40 | 40 |
| Not completed | 0 | 0 |
| Milestone | Stepped Furosemide | Diuretics Combined |
|---|---|---|
| Started | 40 | 40 |
| Completed | 35 | 33 |
| Not completed | 5 | 7 |
| Withdrew: Early improvement | 5 | 7 |
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)
| Participants | Stepped Furosemide | Diuretics Combined |
|---|---|---|
| Number of Participants With Renal Function Recovery Defined as a Return to Individual Baseline Serum Creatinine Values | 8 | 5 |
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
| ml | Stepped Furosemide | Diuretics Combined |
|---|---|---|
| Change in 24 Hour Urine Output at 96 Hours After Intervention Started From 24 Hour Urine Output One Day Before Intervention Initiation) | 125 (-350 to 1312) | 200 (-625 to 363) |
Calculated as serum creatinine at day one minus serum creatinine at 96 hrs after intervention started
| mg/dl | Stepped Furosemide | Diuretics Combined |
|---|---|---|
| Change in Serum Creatinine at Day One of Intervention From Serum Creatinine at 96 Hrs After Intervention Started | 0.02 (-0.3 to 0.6) | 0.2 (-0.02 to 0.5) |
| Participants | Stepped Furosemide | Diuretics Combined |
|---|---|---|
| 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 | 20 | 24 |
| Participants | Stepped Furosemide | Diuretics Combined |
|---|---|---|
| In Hospital Mortality Defined as Number of Dead Patients From Day One of Intervention and Before Discharge | 4 | 4 |
| Participants | Stepped Furosemide | Diuretics Combined |
|---|---|---|
| Mortality During Follow up Defined as Number of Dead Patients After Discharge | 9 | 12 |
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
| Participants | Stepped Furosemide | Diuretics Combined |
|---|---|---|
| Number of Patients With Dyspnea Improvement as Referred by the Patient or Reduction in Supplementary Oxygen Requirements at 96 Hours After Intervention Started | 27 | 27 |
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
| Participants | Stepped Furosemide | Diuretics Combined |
|---|---|---|
| Number of Patients With Dyspnea Improvement as Referred by the Patient or Reduction in Supplementary Oxygen Requirements Before Day 3 of Intervention | 2 | 7 |
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
| days | Stepped Furosemide | Diuretics Combined |
|---|---|---|
| Number of Days From the Beginning of the Intervention Until Patients Referred Dyspnea Improvement or a Reduction in Supplementary Oxygen Requirements Was Made. | 4 (3 to 4) | 4 (2.2 to 4) |
The requirement of renal replacement therapy was assessed by the nephrology team in charge
| Participants | Stepped Furosemide | Diuretics Combined |
|---|---|---|
| Number of Patients That Required Renal Replacement Therapy of Any Type During Intervention (4 Days). | 7 | 6 |
Calculated as serum copeptin levels at day one minus serum copeptin levels measured at 96 hrs after intervention started
| ng/dl | Stepped Furosemide | Diuretics Combined |
|---|---|---|
| Change in Serum Copeptin Levels at Day One of Intervention From Serum Copeptin Levels Measured at 96 Hrs After Intervention Started. | 1.1 (-20 to 21) | -16 (-26 to 13) |
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
| ng/dl | Stepped Furosemide | Diuretics Combined |
|---|---|---|
| Change in Serum Brain Natriuretic Peptide Levels at Baseline From Serum Brain Natriuretic Peptide Levels at 96 Hours After Intervention Started | -1344 ± 1041 | -1378 ± 1904 |
Baseline levels were defined as the measurement at hospital admission
| Participants | Stepped Furosemide | Diuretics Combined |
|---|---|---|
| Number of Patients That Achieved >30% Reduction in Brain Natriuretic Compared With Baseline Levels | 5 | 7 |
Clinical improvement was referred as remission of symptoms with achievement of 24 hour urine output equal or greater than 3000 milliliters
| Participants | Stepped Furosemide | Diuretics Combined |
|---|---|---|
| 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. | 5 | 7 |
Calculated as serum urea levels at day one of intervention minus serum urea levels at 96 hrs after intervention started.
| mg/dl | Stepped Furosemide | Diuretics Combined |
|---|---|---|
| Change in Serum Urea Levels Measured at Day One of Intervention From Serum Urea Levels Measured at 96 Hrs After Intervention Started. | 13 (-11 to 37) | 18 (-1 to 45) |
Calculated as serum sodium levels at day one of intervention minus serum sodium levels at 96 hrs after intervention started.
| mEq/L | Stepped Furosemide | Diuretics Combined |
|---|---|---|
| Change in Serum Sodium Levels Measured at Day One of Intervention From Serum Sodium Levels Measured at 96 Hrs After Intervention Started. | -1.2 ± 4.7 | 0.2 ± 4.7 |
Calculated as serum potassium levels at day one of intervention minus serum potassium levels at 96 hrs after intervention started.
| mEq/L | Stepped Furosemide | Diuretics Combined |
|---|---|---|
| Change in Serum Potassium Levels Measured at Day One of Intervention From Serum Potassium Levels Measured at 96 Hrs After Intervention Started. | -0.2 ± 0.9 | -0.4 ± 0.8 |
Calculated as serum chloride levels at day one of intervention minus serum chloride levels at 96 hrs after intervention started.
| mEq/L | Stepped Furosemide | Diuretics Combined |
|---|---|---|
| Change in Serum Chloride Levels Measured at Day One of Intervention From Serum Chloride Levels Measured at 96 Hrs After Intervention Started. | -0.6 ± 6.4 | -0.4 ± 4.7 |
Calculated as serum magnesium levels at day one of intervention minus serum magnesium levels at 96 hrs after intervention started.
| mg/dl | Stepped Furosemide | Diuretics Combined |
|---|---|---|
| Change in Serum Magnesium Levels Measured at Day One of Intervention From Serum Magnesium Levels Measured at 96 Hrs After Intervention Started. | 0.07 ± 0.16 | -0.04 ± 0.2 |
Calculated as serum calcium levels at day one of intervention minus serum calcium levels at 96 hrs after intervention started.
| mg/dl | Stepped Furosemide | Diuretics Combined |
|---|---|---|
| Change in Serum Calcium Levels Measured at Day One of Intervention From Serum Calcium Levels Measured at 96 Hrs After Intervention Started. | 0.15 (-0.4 to 0.6) | -0.05 (-0.2 to 0.3) |
Calculated as serum pH value at day one of intervention minus serum pH value at 96 hrs after intervention started.
| units | Stepped Furosemide | Diuretics Combined |
|---|---|---|
| Change in Serum pH Value Measured at Day One of Intervention From Serum pH Value Measured at 96 Hrs After Intervention Started. | 0.03 ± 0.07 | 0.02 ± 0.04 |
Calculated as serum bicarbonate levels at day one of intervention minus bicarbonate levels at 96 hrs after intervention started.
| mEq/L | Stepped Furosemide | Diuretics Combined |
|---|---|---|
| Change in Serum Bicarbonate Levels Measured at Day One of Intervention From Serum Bicarbonate Levels Measured at 96 Hrs After Intervention Started. | 2.9 (0.3 to 5.5) | 3 (1.1 to 4.7) |
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.
| mmHg | Stepped Furosemide | Diuretics Combined |
|---|---|---|
| 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. | 1 (-2 to 6.7) | 3 (-1.5 to 6) |
Calculated as serum lactate levels at day one of intervention minus serum lactate levels at 96 hrs after intervention started.
| mmol/L | Stepped Furosemide | Diuretics Combined |
|---|---|---|
| Change in Serum Lactate Levels Measured at Day One of Intervention From Serum Lactate Levels Measured at 96 Hrs After Intervention Started. | 0 (-0.3 to 0.4) | 0.1 (-0.2 to 0.3) |
Collected over All-cause mortality was assessed at hospitalisation and during follow-up which lasted an average of 182 days. Serious adverse events and other adverse events were assessed during the 4 days that the intervention lasted.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Stepped Furosemide | 13/40 (32.5%) | 4/40 (10%) | 36/40 (90%) |
| Diuretics Combined | 16/40 (40%) | 1/40 (2.5%) | 35/40 (87.5%) |
| Event | Stepped Furosemide | Diuretics Combined |
|---|---|---|
| HypotensionVascular disorders | 4/40 | 1/40 |
| Event | Stepped Furosemide | Diuretics Combined |
|---|---|---|
| HyponatremiaRenal and urinary disorders | 18/40 | 18/40 |
| Metabolic alkalosisRenal and urinary disorders | 12/40 | 12/40 |
| HypokalemiaRenal and urinary disorders | 8/40 | 7/40 |
| Age, Continuous(years) | Stepped Furosemide | Diuretics Combined | Total |
|---|---|---|---|
| Mean | 58 ± 14.5 | 59 ± 14.6 | 59 ± 14.5 |
| Sex: Female, Male(Participants) | Stepped Furosemide | Diuretics Combined | Total |
|---|---|---|---|
| Female | 21 | 22 | 43 |
| Male | 19 | 18 | 37 |
| Ethnicity (NIH/OMB)(Participants) | Stepped Furosemide | Diuretics Combined | Total |
|---|---|---|---|
| Hispanic or Latino | 40 | 40 | 80 |
| Not Hispanic or Latino | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Diabetes(Participants) | Stepped Furosemide | Diuretics Combined | Total |
|---|---|---|---|
| Count of participants | 25 | 30 | 55 |
| Hypertension(Participants) | Stepped Furosemide | Diuretics Combined | Total |
|---|---|---|---|
| Count of participants | 29 | 35 | 64 |
| Baseline serum creatinine(mg/dl) | Stepped Furosemide | Diuretics Combined | Total |
|---|---|---|---|
| Mean | 3.1 (2.2 to 4.7) | 2.8 (2.1 to 4) | 2.9 (2.2 to 4.5) |
| Chronic kidney disease(Participants) | Stepped Furosemide | Diuretics Combined | Total |
|---|---|---|---|
| Count of participants | 16 | 18 | 34 |
| Baseline estimated glomerular filtration rate(ml/min/1.73m^2) | Stepped Furosemide | Diuretics Combined | Total |
|---|---|---|---|
| Mean | 31 (18 to 40) | 28 (16 to 58) | 28 (18 to 49) |
27 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
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Hospital Civil de Guadalajara