Diabetes, Heart Failure, Kidney Failure, Acute, Kidney Failure, Chronic
Conditions
Keywords
Acute kidney failure, CT scan, Iodine contrast, Sodium chloride
Brief summary
This phase II, open, non-inferiority, randomized and controlled clinical trial is aimed to ascertain the incidence of contrast nephropathy in outpatients undergoing CT scan with contrast. Patients will be randomized to receive oral prophylaxis with capsules of sodium chloride and free water ingestion or prophylaxis with sodium chloride 0.9% intravenous solution. The total dose (mmol) of sodium chloride will be the same regardless administration via. The contrast will be iodixanol. Patients \>65 years, of both sexes, with at least one of the following criteria: diabetes, stable heart failure or chronic kidney disease (estimated glomerular filtration rate between 30 and 60 ml/min), undergoing CT scan with contrast, and who give written informed consent, will be included in the study. Patients with estimated glomerular filtration rate \<30 ml/min, serum potassium \<3.5 mEq/L, infusion of iodine contrast in the previous 15 days, administration of nephrotoxic drugs in the previous 72 hours or expected in the following hours after contrast infusion, decompensated chronic conditions (heart failure, chronic obstructive pulmonary disease, hypertension), allergy to iodine contrast, or the presence of hyperchloremia or hypernatremia, will be excluded from the study. Contrast nephropathy will be defined as the increase of serum creatinine \>0.3 mg/dL from baseline, or the reduction of estimated glomerular filtration rate (MDRD-4) \>25% from baseline, in the first 48 hours after contrast administration.
Detailed description
This phase II, open, non-inferiority, randomized and controlled clinical trial is aimed to ascertain the incidence of contrast nephropathy in outpatients undergoing CT scan with contrast. Patients will be randomized to receive oral prophylaxis with capsules of sodium chloride and free water ingestion or prophylaxis with sodium chloride 0.9% intravenous solution. In those patients randomly allocated to oral prophylaxis (n=133), patients will receive capsules of sodium chloride and free water ingestion (for each capsule of sodium chloride, patients will take 250 ml of water, assuring a minimum ingestion of 750 ml of water) in the 48 hours prior contrast injection. Patients will take capsules of sodium chloride at a dose of 100 mg/kg during 48 hours previous the injection of contrast (48, 40, 32, 24, 16, and 8 hours), at the moment of contrast injection and 12 hours after the injection of contrast. In those patients randomly allocated to receive sodium chloride 0.9% intravenous solution (n=133), patients will receive at hospital 3 ml/Kg of sodium chloride 0.9%, one hour previous contrast injection and 2 ml/kg during the 4 hours after contrast injection. The total dose (mmol) of sodium chloride will be the same regardless administration via. The contrast will be iodixanol (320 mg of iodine/ml, in 100 ml, at an infusion rate of 2-5 ml/sec). Patients \>65 years, of both sexes, with at least one of the following criteria: diabetes, stable heart failure or chronic kidney disease (estimated glomerular filtration rate between 30 and 60 ml/min), undergoing CT scan with contrast, and who give written informed consent, will be included in the study. Patients with estimated glomerular filtration rate \<30 ml/min, serum potassium \<3.5 mEq/L, infusion of iodine contrast in the previous 15 days, administration of nephrotoxic drugs in the previous 72 hours or expected in the following hours after contrast infusion, decompensated chronic conditions (heart failure, chronic obstructive pulmonary disease, hypertension), allergy to iodine contrast, or the presence of hyperchloremia or hypernatremia, will be excluded from the study. Contrast nephropathy will be defined as the increase of serum creatinine \>0.3 mg/dL from baseline, or the reduction of estimated glomerular filtration rate (MDRD-4) \>25% from baseline, in the first 48 hours after contrast administration.
Interventions
Patients will receive capsules of sodium chloride and free water ingestion (for each capsule of sodium chloride, with 250 ml of water, assuring a minimum ingestion of 750 ml of water) in the 48 hours prior contrast injection. Patients will take capsules of sodium chloride at a dose of 100 mg/kg during 48 hours previous the injection of contrast (48, 40, 32, 24, 16, and 8 hours), at the moment of contrast injection and 12 hours after the injection of contrast.
DRUGIntravenous sodium chloride
Patients will receive at hospital 3 ml/Kg of sodium chloride 0.9%, one hour previous contrast injection and 2 ml/kg during the 4 hours after contrast injection.
Sponsors
Instituto de Salud Carlos III
Ministerio de Sanidad, Servicios Sociales e Igualdad
Hospital Universitario Ramon y Cajal
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients \>65 years, * Both sexes, * With at least one of the following criteria: diabetes or stable heart failure or chronic kidney disease (estimated glomerular filtration rate between 30 and 60 ml/min), * Undergoing CT scan with contrast * Written informed consent.
Exclusion criteria
* Estimated glomerular filtration rate \<30 ml/min, * Serum potassium \<3.5 mEq/L, * Infusion of iodine contrast in the previous 15 days, * Administration of nephrotoxic drugs in the previous 72 hours or expected in the following hours after contrast infusion, * Decompensated chronic conditions (heart failure, chronic obstructive pulmonary disease, hypertension), * Allergy to iodine contrast, * Presence of hyperchloremia or hypernatremia.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Acute Kidney Injury During the First 48 Hours After Contrast Administration | Within 48h after contrast administration | Contrast-Associated Acute Kidney Injury, defined as the increase of serum creatinine \>0.3 mg/dL from baseline, or the reduction of estimated glomerular filtration rate (MDRD-4) \>25%, within 48h after contrast administration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Estimated Glomerular Filtration Rate (eGFR) at 48h From Baseline | 48 hours from contrast administration (baseline) | Estimated glomerular filtration rate (eGFR) according to MDRD-4 at 48 hours from contrast administration (baseline), as an secondary efficacy laboratory assessment. |
| Serum Creatinine at 24h From Baseline | 24 hours from contrast administration (baseline) | Serum creatinine at 24 hours from contrast administration (baseline), as an secondary efficacy laboratory assessment. |
| Serum Creatinine at 48h From Baseline | 48 hours from contrast administration (baseline) | Serum creatinine at 48 hours from contrast administration (baseline), as an secondary efficacy laboratory assessment. |
| Cystatin C at 24h From Baseline | 24 hours from contrast administration (baseline) | Cystatin C at 24 hours from contrast administration (baseline), as an secondary efficacy laboratory assessment. |
| Cystatin C at 48h From Baseline | 48 hours from contrast administration (baseline) | Cystatin C at 48 hours from contrast administration (baseline), as an secondary efficacy laboratory assessment. |
| Albumin-to-creatinine Ratio at 24h From Baseline | 24 hours from contrast administration (baseline) | Albumin-to-creatinine ratio at 24 hours from contrast administration (baseline), as an secondary efficacy laboratory assessment. |
| Estimated Glomerular Filtration Rate (eGFR) at 24h From Baseline | 24 hours from contrast administration (baseline) | Estimated glomerular filtration rate (eGFR) according to MDRD-4 at 24 hours from contrast administration (baseline), as an secondary efficacy laboratory assessment. |
| Urea at 24h From Baseline | 24 hours from contrast administration (baseline) | Urea at 24 hours from contrast administration (baseline), as an secondary efficacy laboratory assessment. |
| Urea at 48h From Baseline | 48 hours from contrast administration (baseline) | Urea at 48 hours from contrast administration (baseline), as an secondary efficacy laboratory assessment. |
| Serum Sodium at 24h From Baseline | 24 hours from contrast administration (baseline) | Serum sodium at 24 hours from contrast administration (baseline), as an secondary efficacy laboratory assessment. |
| Serum Sodium at 48h From Baseline | 48 hours from contrast administration (baseline) | Serum sodium at 48 hours from contrast administration (baseline), as an secondary efficacy laboratory assessment. |
| Serum Potassium at 24h From Baseline | 24 hours from contrast administration (baseline) | Serum potassium at 24 hours from contrast administration (baseline), as an secondary efficacy laboratory assessment. |
| Serum Potassium at 48h From Baseline | 48 hours from contrast administration (baseline) | Serum potassium at 48 hours from contrast administration (baseline), as an secondary efficacy laboratory assessment. |
| Albumin-to-creatinine Ratio at 48h From Baseline | 48 hours from contrast administration (baseline) | Albumin-to-creatinine ratio at 48 hours from contrast administration (baseline), as an secondary efficacy laboratory assessment. |
Countries
Spain
Participant flow
Recruitment details
Participants were recruited at Hospital Universitario Ramón y Cajal, Madrid, Spain, between April 2014 and November 2019.
Pre-assignment details
A total of 271 patients were enrolled in the study, of whom 19 (7.0%) did not meet the criteria for per-protocol analysis and were therefore excluded from the main analysis. The reasons for exclusion included voluntary withdrawal (n=5), hospitalisation for bronchospasm (n=1), missing laboratory tests (n=10), and non-compliance with treatment (n=3). Thus, the main analysis (per-protocol) consisted of n=252 patients, of whom 123 received oral hydration and 129 received intravenous hydration.
Participants by arm
| Arm | Count |
|---|---|
| Oral Sodium Chloride Patients will receive capsules of sodium chloride and free water ingestion (for each capsule of sodium chloride, patients will take 250 ml of water, assuring a minimum ingestion of 750 ml of water) in the 48 hours prior contrast injection. Patients will take capsules of sodium chloride at a dose of 100 mg/kg during 48 hours previous the injection of contrast (48, 40, 32, 24, 16, and 8 hours), at the moment of contrast injection and 12 hours after the injection of contrast.
Oral sodium chloride: Patients will receive capsules of sodium chloride and free water ingestion (for each capsule of sodium chloride, with 250 ml of water, assuring a minimum ingestion of 750 ml of water) in the 48 hours prior contrast injection. Patients will take capsules of sodium chloride at a dose of 100 mg/kg during 48 hours previous the injection of contrast (48, 40, 32, 24, 16, and 8 hours), at the moment of contrast injection and 12 hours after the injection of contrast. | 123 |
| Intravenous Sodium Chloride Patients will receive at hospital 3 ml/Kg of sodium chloride 0.9%, one hour previous contrast injection and 2 ml/kg during the 4 hours after contrast injection.
Intravenous sodium chloride: Patients will receive at hospital 3 ml/Kg of sodium chloride 0.9%, one hour previous contrast injection and 2 ml/kg during the 4 hours after contrast injection. | 129 |
| Total | 252 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 |
| Overall Study | Missing laboratory tests | 5 | 5 |
| Overall Study | Non-compliance with treatment | 3 | 0 |
| Overall Study | Withdrawal by Subject | 3 | 2 |
Baseline characteristics
| Characteristic | Oral Sodium Chloride | Intravenous Sodium Chloride | Total |
|---|---|---|---|
| Age, Continuous | 74.1 years STANDARD_DEVIATION 6.1 | 74.6 years STANDARD_DEVIATION 6.8 | 74.4 years STANDARD_DEVIATION 6.4 |
| Albumin-to-creatinine ratio | 17.4 mg/g | 19.4 mg/g | 19.0 mg/g |
| Body mass index (BMI) | 23.0 Kg/m^2 STANDARD_DEVIATION 3.9 | 23.0 Kg/m^2 STANDARD_DEVIATION 3.7 | 23.0 Kg/m^2 STANDARD_DEVIATION 3.8 |
| B-type natriuretic peptide (BNP) | 56.6 pg/mg | 54.0 pg/mg | 55.9 pg/mg |
| Cancer | 68 Participants | 59 Participants | 127 Participants |
| Chronic kidney disease | 53 Participants | 47 Participants | 100 Participants |
| Current smoker | 5 Participants | 9 Participants | 14 Participants |
| Cystatin C | 1.36 mg/dL STANDARD_DEVIATION 0.39 | 1.41 mg/dL STANDARD_DEVIATION 0.46 | 1.38 mg/dL STANDARD_DEVIATION 0.43 |
| Diabetes | 87 Participants | 97 Participants | 184 Participants |
| Diuretics | 48 Participants | 45 Participants | 93 Participants |
| Estimated glomerular filtration rate (eGFR) according to MDRD-4 | 66.6 mL/min/1.73m^2 STANDARD_DEVIATION 19.4 | 69.0 mL/min/1.73m^2 STANDARD_DEVIATION 19.6 | 67.8 mL/min/1.73m^2 STANDARD_DEVIATION 19.5 |
| Heart failure | 16 Participants | 25 Participants | 41 Participants |
| Heart rate | 71.1 bpm STANDARD_DEVIATION 13.9 | 70.9 bpm STANDARD_DEVIATION 11.1 | 71.0 bpm STANDARD_DEVIATION 12.6 |
| Hemoglobin | 13.6 g/dL STANDARD_DEVIATION 1.8 | 13.7 g/dL STANDARD_DEVIATION 1.7 | 13.6 g/dL STANDARD_DEVIATION 1.8 |
| Hypertension | 94 Participants | 98 Participants | 192 Participants |
| Lipid-lowering agents | 76 Participants | 79 Participants | 155 Participants |
| Non-diuretic antihypertensives | 95 Participants | 97 Participants | 192 Participants |
| Non-insulin antidiabetic drugs | 81 Participants | 86 Participants | 167 Participants |
| Peripheral artery disease | 11 Participants | 8 Participants | 19 Participants |
| Peripheral oxygen saturation (spO2) | 95.8 percentage of hemoglobin saturation STANDARD_DEVIATION 2.4 | 95.4 percentage of hemoglobin saturation STANDARD_DEVIATION 3 | 95.6 percentage of hemoglobin saturation STANDARD_DEVIATION 2.7 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment Spain | 123 participants | 129 participants | 252 participants |
| Serum creatinine | 1.09 mg/dL STANDARD_DEVIATION 0.31 | 1.02 mg/dL STANDARD_DEVIATION 0.29 | 1.06 mg/dL STANDARD_DEVIATION 0.3 |
| Serum potassium | 4.5 mg/dL STANDARD_DEVIATION 0.4 | 4.5 mg/dL STANDARD_DEVIATION 0.5 | 4.5 mg/dL STANDARD_DEVIATION 0.5 |
| Serum sodium | 139.2 mg/dL STANDARD_DEVIATION 2.6 | 139.6 mg/dL STANDARD_DEVIATION 3.1 | 139.4 mg/dL STANDARD_DEVIATION 2.9 |
| Sex: Female, Male Female | 34 Participants | 50 Participants | 84 Participants |
| Sex: Female, Male Male | 89 Participants | 79 Participants | 168 Participants |
| Systolic blood pressure (SBP) | 140.2 mmHg STANDARD_DEVIATION 19.8 | 143.1 mmHg STANDARD_DEVIATION 20.2 | 141.7 mmHg STANDARD_DEVIATION 20 |
| Urea | 49.1 mg/dL STANDARD_DEVIATION 16.2 | 46.7 mg/dL STANDARD_DEVIATION 18.8 | 47.8 mg/dL STANDARD_DEVIATION 17.6 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 134 | 0 / 137 |
| other Total, other adverse events | 31 / 134 | 6 / 137 |
| serious Total, serious adverse events | 0 / 134 | 0 / 137 |
Outcome results
Primary
Number of Participants With Acute Kidney Injury During the First 48 Hours After Contrast Administration
Contrast-Associated Acute Kidney Injury, defined as the increase of serum creatinine \>0.3 mg/dL from baseline, or the reduction of estimated glomerular filtration rate (MDRD-4) \>25%, within 48h after contrast administration
Time frame: Within 48h after contrast administration
Population: Per-protocol population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Oral Sodium Chloride | Number of Participants With Acute Kidney Injury During the First 48 Hours After Contrast Administration | 5 Participants |
| Intravenous Sodium Chloride | Number of Participants With Acute Kidney Injury During the First 48 Hours After Contrast Administration | 4 Participants |
Comparison: Sample size was calculated to assess the non-inferiority of oral compared to intravenous hydration. We expected a primary outcome rate of 7% in the intravenous arm. We considered a priori a difference of no more than 5% in the incidence of CA-AKI in the oral compared to the intravenous arm (non-inferiority margin) to be acceptable. Thus, 266 participants, 133 per arm, were required to ensure at least 80% power at a significance level of α = 2.5% (one-sided).95% CI: [-4.8, 7]
Secondary
Albumin-to-creatinine Ratio at 24h From Baseline
Albumin-to-creatinine ratio at 24 hours from contrast administration (baseline), as an secondary efficacy laboratory assessment.
Time frame: 24 hours from contrast administration (baseline)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Oral Sodium Chloride | Albumin-to-creatinine Ratio at 24h From Baseline | 17.2 mg/g |
| Intravenous Sodium Chloride | Albumin-to-creatinine Ratio at 24h From Baseline | 17.0 mg/g |
p-value: 0.72Wilcoxon (Mann-Whitney)
Secondary
Albumin-to-creatinine Ratio at 48h From Baseline
Albumin-to-creatinine ratio at 48 hours from contrast administration (baseline), as an secondary efficacy laboratory assessment.
Time frame: 48 hours from contrast administration (baseline)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Oral Sodium Chloride | Albumin-to-creatinine Ratio at 48h From Baseline | 17.6 mg/g |
| Intravenous Sodium Chloride | Albumin-to-creatinine Ratio at 48h From Baseline | 18.2 mg/g |
p-value: 0.688Wilcoxon (Mann-Whitney)
Secondary
Cystatin C at 24h From Baseline
Cystatin C at 24 hours from contrast administration (baseline), as an secondary efficacy laboratory assessment.
Time frame: 24 hours from contrast administration (baseline)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oral Sodium Chloride | Cystatin C at 24h From Baseline | 1.38 mg/dL | Standard Deviation 0.44 |
| Intravenous Sodium Chloride | Cystatin C at 24h From Baseline | 1.33 mg/dL | Standard Deviation 0.46 |
p-value: 0.418t-test, 2 sided
Secondary
Cystatin C at 48h From Baseline
Cystatin C at 48 hours from contrast administration (baseline), as an secondary efficacy laboratory assessment.
Time frame: 48 hours from contrast administration (baseline)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oral Sodium Chloride | Cystatin C at 48h From Baseline | 1.36 mg/dL | Standard Deviation 0.43 |
| Intravenous Sodium Chloride | Cystatin C at 48h From Baseline | 1.36 mg/dL | Standard Deviation 0.46 |
p-value: 0.901t-test, 2 sided
Secondary
Estimated Glomerular Filtration Rate (eGFR) at 24h From Baseline
Estimated glomerular filtration rate (eGFR) according to MDRD-4 at 24 hours from contrast administration (baseline), as an secondary efficacy laboratory assessment.
Time frame: 24 hours from contrast administration (baseline)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oral Sodium Chloride | Estimated Glomerular Filtration Rate (eGFR) at 24h From Baseline | 66.4 mL/min/1.73 m^2 | Standard Deviation 18.9 |
| Intravenous Sodium Chloride | Estimated Glomerular Filtration Rate (eGFR) at 24h From Baseline | 68.8 mL/min/1.73 m^2 | Standard Deviation 18.9 |
Comparison: Comparison between means of both arms at 24h from baselinep-value: 0.299t-test, 2 sided
Secondary
Estimated Glomerular Filtration Rate (eGFR) at 48h From Baseline
Estimated glomerular filtration rate (eGFR) according to MDRD-4 at 48 hours from contrast administration (baseline), as an secondary efficacy laboratory assessment.
Time frame: 48 hours from contrast administration (baseline)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oral Sodium Chloride | Estimated Glomerular Filtration Rate (eGFR) at 48h From Baseline | 66.1 mL/min/1.73 m^2 | Standard Deviation 19.7 |
| Intravenous Sodium Chloride | Estimated Glomerular Filtration Rate (eGFR) at 48h From Baseline | 67.9 mL/min/1.73 m^2 | Standard Deviation 19.6 |
Comparison: Comparison between means of both arms at 48h from baselinep-value: 0.477t-test, 2 sided
Secondary
Serum Creatinine at 24h From Baseline
Serum creatinine at 24 hours from contrast administration (baseline), as an secondary efficacy laboratory assessment.
Time frame: 24 hours from contrast administration (baseline)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oral Sodium Chloride | Serum Creatinine at 24h From Baseline | 1.10 mg/dL | Standard Deviation 0.33 |
| Intravenous Sodium Chloride | Serum Creatinine at 24h From Baseline | 1.02 mg/dL | Standard Deviation 0.29 |
p-value: 0.042t-test, 2 sided
Secondary
Serum Creatinine at 48h From Baseline
Serum creatinine at 48 hours from contrast administration (baseline), as an secondary efficacy laboratory assessment.
Time frame: 48 hours from contrast administration (baseline)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oral Sodium Chloride | Serum Creatinine at 48h From Baseline | 1.10 mg/dL | Standard Deviation 0.36 |
| Intravenous Sodium Chloride | Serum Creatinine at 48h From Baseline | 1.04 mg/dL | Standard Deviation 0.31 |
p-value: 0.121t-test, 2 sided
Secondary
Serum Potassium at 24h From Baseline
Serum potassium at 24 hours from contrast administration (baseline), as an secondary efficacy laboratory assessment.
Time frame: 24 hours from contrast administration (baseline)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oral Sodium Chloride | Serum Potassium at 24h From Baseline | 4.4 mg/dL | Standard Deviation 0.4 |
| Intravenous Sodium Chloride | Serum Potassium at 24h From Baseline | 4.4 mg/dL | Standard Deviation 0.5 |
p-value: 0.893t-test, 2 sided
Secondary
Serum Potassium at 48h From Baseline
Serum potassium at 48 hours from contrast administration (baseline), as an secondary efficacy laboratory assessment.
Time frame: 48 hours from contrast administration (baseline)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oral Sodium Chloride | Serum Potassium at 48h From Baseline | 4.4 mg/dL | Standard Deviation 0.4 |
| Intravenous Sodium Chloride | Serum Potassium at 48h From Baseline | 4.5 mg/dL | Standard Deviation 0.5 |
p-value: 0.645t-test, 2 sided
Secondary
Serum Sodium at 24h From Baseline
Serum sodium at 24 hours from contrast administration (baseline), as an secondary efficacy laboratory assessment.
Time frame: 24 hours from contrast administration (baseline)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oral Sodium Chloride | Serum Sodium at 24h From Baseline | 139.4 mg/dL | Standard Deviation 2.6 |
| Intravenous Sodium Chloride | Serum Sodium at 24h From Baseline | 139.3 mg/dL | Standard Deviation 2.6 |
p-value: 0.764t-test, 2 sided
Secondary
Serum Sodium at 48h From Baseline
Serum sodium at 48 hours from contrast administration (baseline), as an secondary efficacy laboratory assessment.
Time frame: 48 hours from contrast administration (baseline)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oral Sodium Chloride | Serum Sodium at 48h From Baseline | 139.2 mg/dL | Standard Deviation 2.7 |
| Intravenous Sodium Chloride | Serum Sodium at 48h From Baseline | 139.4 mg/dL | Standard Deviation 2.6 |
p-value: 0.458t-test, 2 sided
Secondary
Urea at 24h From Baseline
Urea at 24 hours from contrast administration (baseline), as an secondary efficacy laboratory assessment.
Time frame: 24 hours from contrast administration (baseline)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oral Sodium Chloride | Urea at 24h From Baseline | 43.7 mg/dL | Standard Deviation 18.7 |
| Intravenous Sodium Chloride | Urea at 24h From Baseline | 42.2 mg/dL | Standard Deviation 18.2 |
p-value: 0.535t-test, 2 sided
Secondary
Urea at 48h From Baseline
Urea at 48 hours from contrast administration (baseline), as an secondary efficacy laboratory assessment.
Time frame: 48 hours from contrast administration (baseline)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oral Sodium Chloride | Urea at 48h From Baseline | 46.0 mg/dL | Standard Deviation 19.5 |
| Intravenous Sodium Chloride | Urea at 48h From Baseline | 43.5 mg/dL | Standard Deviation 20.1 |
p-value: 0.338t-test, 2 sided