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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GROUP A | Experimental | Furosemide 80 mg every 24 hrs (morning) intravenously every 24 hrs for 4 consecutive days, additionally:
|
|
| GROUP B | Experimental | Furosemide 80 mg every 24 hrs (morning) intravenously every 24 hrs for 4 consecutive days, additionally:
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Change in Serum Brain Natriuretic Peptide Levels at Baseline From Serum Brain Natriuretic Peptide Levels at 96 Hours After Intervention Started |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HCG | Guadalajara | Jalisco | 44240 | Mexico | ||
| Hospital Civil de Guadalajara |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34979962 | Derived | 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. |
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Of 168 patients assessed for eligibility, 80 met inclusion criteria and were randomized to treatment
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Stepped Furosemide | Furosemide 80 mg every 24 hrs (morning) intravenously every 24 hrs for 4 consecutive days, additionally continuous infused furosemide as follows:
|
| FG001 | Diuretics Combined | Furosemide 80 mg every 24 hrs (morning) intravenously every 24 hrs for 4 consecutive days, additionally:
|
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Follow up |
| |||||||||||||
| First 4 Days of Intervention |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Stepped Furosemide | Furosemide 80 mg every 24 hrs (morning) intravenously every 24 hrs for 4 consecutive days, additionally:
|
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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) | Posted | Count of Participants | Participants | Up to 96 hours after intervention started |
|
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.
We assessed serious adverse events and other adverse events through daily clinical evaluation by one member of the nephrology team in charge and daily laboratory testing for serum creatinine, urea, glucose, sodium, potassium, chlorine, calcium, phosphorous, arterial or venous blood gas, and complete blood count.
All cause mortality during follow-up was assessed through monthly phone calls to patients and/or searching at Hospital electronic records.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Stepped Furosemide | Furosemide 80 mg every 24 hrs (morning) intravenously every 24 hrs for 4 consecutive days, additionally continuous infused furosemide as follows:
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypotension | Vascular disorders | Systematic Assessment | Any systolic blood pressure < 90mmHg and/or mean arterial pressure <65 mmHg |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypokalemia | Renal and urinary disorders | Systematic Assessment | Any serum potassium < 3.5 mEq/L during the intervention (4 days) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Jonathan Chavez Iñiguez | hospital civil de guadalajara | 3313299609 | jonarchi_10@hotmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 17, 2020 | Aug 21, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 17, 2020 | Aug 21, 2020 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D059347 | Cardio-Renal Syndrome |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D002752 | Chlorthalidone |
| D013148 | Spironolactone |
| ID | Term |
|---|---|
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
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Its a randomized, controlled, phase II, 2-arm, double-blind clinical trial
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Double-blind clinical trial
| 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 |
|
| 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 |
| 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 |
| 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 |
| Mortality During Follow up Defined as Number of Dead Patients After Discharge | 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 | 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 | 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 | 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 | Up to 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Guadalajara |
| Jalisco |
| 44240 |
| Mexico |
| NOT COMPLETED |
|
|
| BG001 | Diuretics Combined | Furosemide 80 mg every 24 hrs (morning) intravenously every 24 hrs for 4 consecutive days, additionally:
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Diabetes | Hospital medical record of diabetes diagnosis or current use of antidiabetic drugs | Patients without the information required to assess this variable where excluded from the calculation | Count of Participants | Participants |
|
| Hypertension | Hospital medical record of hypertension diagnosis or current use of antihypertensive drugs | Patients without the information required to assess this variable where excluded from the calculation | Count of Participants | Participants |
|
| Baseline serum creatinine | Recorded serum creatinine form at least 3 months ago and up to one year ago | Mean | Inter-Quartile Range | mg/dl |
|
| Chronic kidney disease | Medical record of chronic kidney disease or as defined by KDIGO guidelines. | Patients without the information required to assess this variable where excluded from the calculation | Count of Participants | Participants |
|
| Baseline estimated glomerular filtration rate | Mean | Inter-Quartile Range | ml/min/1.73m^2 |
|
| Acute myocardial infarction | Diagnosis of acute myocardial infarction by the cardiology service at admission. Our Hospital uses troponin levels, electrocardiographic changes and coronary angiography | Patients without the information required to assess this variable where excluded from the calculation | Count of Participants | Participants |
|
| Chronic heart failure | Medical record of chronic heart failure diagnosis or previous echocardiographic study showing reduced left ventricular ejection fraction (<40%) or diastolic disfunction (elevated filling pressures). | Patients without the information required to assess this variable where excluded from the calculation | Count of Participants | Participants |
|
| Hypothyroidism | Medical record of hypothyroidism diagnosis or diagnosed at hospitalisation with thyroid stimulating hormone and free T4 measures. | Patients without the information required to assess this variable where excluded from the calculation | Count of Participants | Participants |
|
| Arrythmia | Medical record of any type of arrythmia or diagnosed at admission. | Patients without the information required to assess this variable where excluded from the calculation | Count of Participants | Participants |
|
| Current smoker | Patient self reported current smoking | Patients without the information required to assess this variable where excluded from the calculation | Count of Participants | Participants |
|
| Heart rate | Mean | Inter-Quartile Range | beats per minute |
|
| Oxygen saturation | Individual average of measurements of one day before intervention started. Measurements made with pulse oximeter | Mean | Inter-Quartile Range | percentage |
|
| Systolic blood pressure | Individual average of measurements of one day before intervention started. Measurements made with a manual aneroid sphygmomanometer | Mean | Standard Deviation | mmHg |
|
| Diastolic blood pressure | Individual average of measurements of one day before intervention started. Measurements made with a manual aneroid sphygmomanometer | Mean | Standard Deviation | mmHg |
|
| Uric acid | First measurement during hospitalisation or most recent previous levels from up to 3 months ago. | Patients without the information required to assess this variable where excluded from the calculation | Mean | Inter-Quartile Range | mg/dl |
|
| Presence of proteinuria in dipstick urinalysis | Measured with the first dipstick urinalysis during hospitalisation | Patients without the information required to assess this variable where excluded from the calculation | Count of Participants | Participants |
|
| Presence of hematuria in dipstick urinalysis | Measured with the first dipstick urinalysis during hospitalisation | Patients without the information required to assess this variable where excluded from the calculation | Count of Participants | Participants |
|
| Serum brain natriuretic peptide | Brain natriuretic peptide measured at admission as part of evaluation of acute heart failure | Patients without the information required to assess this variable where excluded from the calculation | Mean | Standard Deviation | ng/dl |
|
| Serum copeptin | Levels measured at first day of intervention | Patients without the information required to assess this variable where excluded from the calculation | Mean | Inter-Quartile Range | ng/dl |
|
| Use of antibiotics at admission | Antibiotic prescription at admission or at some point during hospitalisation | Patients without the information required to assess this variable where excluded from the calculation | Count of Participants | Participants |
|
| Blood transfusion during hospitalisation | Requirement of blood transfusion at admission or at some point during hospitalisation. The indication was assessed by the clinical team in charge | Patients without the information required to assess this variable where excluded from the calculation | Count of Participants | Participants |
|
| Use of vasopressor drugs | Prescription of vasopressor drugs at admission or during hospitalisation. | Patients without the information required to assess this variable where excluded from the calculation | Count of Participants | Participants |
|
| Use of inotropic drugs | Prescription of inotropic drugs at admission or during hospitalization . | Patients without the information required to assess this variable where excluded from the calculation | Count of Participants | Participants |
|
| 24 hr urinary volume before intervention | 24 hour urine volume measured one day before intervention started. Measurement was made by a nurse and the urine recollection was made through an urine catheter bag | Mean | Inter-Quartile Range | ml/day |
|
| Use of normal saline as reanimation fluid | Prescription of intravenous normal saline as reanimation or hydration fluid at admission or during intervention | Count of Participants | Participants |
|
| Use of Hartmann solution as reanimation fluid | Prescription of intravenous Hartmann solution as reanimation or hydration fluid at admission or during intervention | Patients without the information required to assess this variable where excluded from the calculation | Count of Participants | Participants |
|
| Previous use of diuretics | Patient self report of previous use of any type of diuretic drug in the last 3 months | Count of Participants | Participants |
|
| Admission to internal medicine service | Patients admitted from emergency department by the internal medicine service | Count of Participants | Participants |
|
| Admission to cardiology service | Patients admitted from emergency department by the cardiology service | Count of Participants | Participants |
|
| Admission to intensive care unit | Patients admitted from emergency department by the intensive care unit service | Count of Participants | Participants |
|
| Admission to surgical service | Patients admitted from emergency department by a surgical service | Count of Participants | Participants |
|
| Admission to other hospital service | Admission to other speciality service than the previously specified | Count of Participants | Participants |
|
| Diuretics Combined |
Furosemide 80 mg every 24 hrs (morning) intravenously every 24 hrs for 4 consecutive days, additionally:
|
|
|
| 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 | Posted | Mean | Inter-Quartile Range | ml | 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 | Posted | Mean | Inter-Quartile Range | mg/dl | 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 | Patients without serum creatinine measured at 96hrs were excluded from this analysis. | Posted | Count of Participants | Participants | 96 hours after intervention started |
|
|
|
| Secondary | In Hospital Mortality Defined as Number of Dead Patients From Day One of Intervention and Before Discharge | Posted | Count of Participants | Participants | 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 | Posted | Count of Participants | Participants | 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 | Posted | Count of Participants | Participants | 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 | Posted | Count of Participants | Participants | 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 | Posted | Mean | Inter-Quartile Range | days | 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 | Posted | Count of Participants | Participants | Up to 96 hours after intervention started |
|
|
|
| Other Pre-specified | 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 | Patients without the copeptin measurements made at day one and/or at 96hrs were excluded from this analysis | Posted | Mean | Inter-Quartile Range | ng/dl | 96 hours after intervention started |
|
|
|
| Other Pre-specified | 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 | Patients without baseline brain natriuretic peptide measurements and/or without measurements at 96hrs were excluded from this analysis | Posted | Mean | Standard Deviation | ng/dl | 96 hours after intervention started |
|
|
|
| Other Pre-specified | Number of Patients That Achieved >30% Reduction in Brain Natriuretic Compared With Baseline Levels | Baseline levels were defined as the measurement at hospital admission | Patients without baseline brain natriuretic peptide measurements and/or without measurements at 96hrs were excluded from this analysis | Posted | Count of Participants | Participants | Up to 96 hours after intervention started |
|
|
|
| Other Pre-specified | 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 | Posted | Count of Participants | Participants | From the beginning of intervention and before 96 hours after that |
|
|
|
| Other Pre-specified | 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. | Posted | Mean | Inter-Quartile Range | mg/dl | 96 hours after intervention started |
|
|
|
| Other Pre-specified | 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. | Posted | Mean | Standard Deviation | mEq/L | 96 hours after intervention started |
|
|
|
| Other Pre-specified | 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. | Posted | Mean | Standard Deviation | mEq/L | 96 hours after intervention started |
|
|
|
| Other Pre-specified | 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. | Posted | Mean | Standard Deviation | mEq/L | 96 hours after intervention started |
|
|
|
| Other Pre-specified | 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. | Posted | Mean | Standard Deviation | mg/dl | 96 hours after intervention started |
|
|
|
| Other Pre-specified | 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. | Posted | Mean | Inter-Quartile Range | mg/dl | 96 hours after intervention started |
|
|
|
| Other Pre-specified | 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. | Posted | Mean | Standard Deviation | units | 96 hours after intervention started |
|
|
|
| Other Pre-specified | 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. | Posted | Mean | Inter-Quartile Range | mEq/L | 96 hours after intervention started |
|
|
|
| Other Pre-specified | 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. | Posted | Mean | Inter-Quartile Range | mmHg | 96 hours after intervention started |
|
|
|
| Other Pre-specified | 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. | Posted | Mean | Inter-Quartile Range | mmol/L | 96 hours after intervention started |
|
|
|
| 13 |
| 40 |
| 4 |
| 40 |
| 36 |
| 40 |
| EG001 | Diuretics Combined | Furosemide 80 mg every 24 hrs (morning) intravenously every 24 hrs for 4 consecutive days, additionally:
| 16 | 40 | 1 | 40 | 35 | 40 |
|
|
| Hyponatremia | Renal and urinary disorders | Systematic Assessment | Any serum sodium < 3.5 mEq/L during the intervention (4 days) |
|
| Metabolic alkalosis | Renal and urinary disorders | Systematic Assessment | Any venous or arterial blood gas bicarbonate levels >28 mEq/L during the intervention (4 days) |
|
Not provided
Not provided
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D006333 | Heart Failure |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001555 |
| Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D001577 | Benzophenones |
| D010797 | Phthalimides |
| D007094 | Imides |
| D007659 | Ketones |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D054833 | Isoindoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D007783 | Lactones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| Unknown or Not Reported |
|