Trial Outcomes & Findings for Sodium Chloride and Contrast Nephropathy (NCT NCT03476460)
NCT ID: NCT03476460
Last Updated: 2025-03-20
Results Overview
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
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
271 participants
Primary outcome timeframe
Within 48h after contrast administration
Results posted on
2025-03-20
Participant Flow
Participants were recruited at Hospital Universitario Ramón y Cajal, Madrid, Spain, between April 2014 and November 2019.
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.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
134
|
137
|
|
Overall Study
COMPLETED
|
123
|
129
|
|
Overall Study
NOT COMPLETED
|
11
|
8
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
2
|
|
Overall Study
Non-compliance with treatment
|
3
|
0
|
|
Overall Study
Missing laboratory tests
|
5
|
5
|
|
Overall Study
Adverse Event
|
0
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Oral Sodium Chloride
n=123 Participants
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.
|
Intravenous Sodium Chloride
n=129 Participants
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.
|
Total
n=252 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
74.1 years
STANDARD_DEVIATION 6.1 • n=123 Participants
|
74.6 years
STANDARD_DEVIATION 6.8 • n=129 Participants
|
74.4 years
STANDARD_DEVIATION 6.4 • n=252 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=123 Participants
|
50 Participants
n=129 Participants
|
84 Participants
n=252 Participants
|
|
Sex: Female, Male
Male
|
89 Participants
n=123 Participants
|
79 Participants
n=129 Participants
|
168 Participants
n=252 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Spain
|
123 participants
n=123 Participants
|
129 participants
n=129 Participants
|
252 participants
n=252 Participants
|
|
Hypertension
|
94 Participants
n=123 Participants
|
98 Participants
n=129 Participants
|
192 Participants
n=252 Participants
|
|
Diabetes
|
87 Participants
n=123 Participants
|
97 Participants
n=129 Participants
|
184 Participants
n=252 Participants
|
|
Current smoker
|
5 Participants
n=123 Participants
|
9 Participants
n=129 Participants
|
14 Participants
n=252 Participants
|
|
Cancer
|
68 Participants
n=123 Participants
|
59 Participants
n=129 Participants
|
127 Participants
n=252 Participants
|
|
Chronic kidney disease
|
53 Participants
n=123 Participants
|
47 Participants
n=129 Participants
|
100 Participants
n=252 Participants
|
|
Heart failure
|
16 Participants
n=123 Participants
|
25 Participants
n=129 Participants
|
41 Participants
n=252 Participants
|
|
Peripheral artery disease
|
11 Participants
n=123 Participants
|
8 Participants
n=129 Participants
|
19 Participants
n=252 Participants
|
|
Estimated glomerular filtration rate (eGFR) according to MDRD-4
|
66.6 mL/min/1.73m^2
STANDARD_DEVIATION 19.4 • n=123 Participants
|
69.0 mL/min/1.73m^2
STANDARD_DEVIATION 19.6 • n=129 Participants
|
67.8 mL/min/1.73m^2
STANDARD_DEVIATION 19.5 • n=252 Participants
|
|
Serum creatinine
|
1.09 mg/dL
STANDARD_DEVIATION 0.31 • n=123 Participants
|
1.02 mg/dL
STANDARD_DEVIATION 0.29 • n=129 Participants
|
1.06 mg/dL
STANDARD_DEVIATION 0.30 • n=252 Participants
|
|
Cystatin C
|
1.36 mg/dL
STANDARD_DEVIATION 0.39 • n=123 Participants
|
1.41 mg/dL
STANDARD_DEVIATION 0.46 • n=129 Participants
|
1.38 mg/dL
STANDARD_DEVIATION 0.43 • n=252 Participants
|
|
Albumin-to-creatinine ratio
|
17.4 mg/g
n=123 Participants
|
19.4 mg/g
n=129 Participants
|
19.0 mg/g
n=252 Participants
|
|
Urea
|
49.1 mg/dL
STANDARD_DEVIATION 16.2 • n=123 Participants
|
46.7 mg/dL
STANDARD_DEVIATION 18.8 • n=129 Participants
|
47.8 mg/dL
STANDARD_DEVIATION 17.6 • n=252 Participants
|
|
Serum sodium
|
139.2 mg/dL
STANDARD_DEVIATION 2.6 • n=123 Participants
|
139.6 mg/dL
STANDARD_DEVIATION 3.1 • n=129 Participants
|
139.4 mg/dL
STANDARD_DEVIATION 2.9 • n=252 Participants
|
|
Serum potassium
|
4.5 mg/dL
STANDARD_DEVIATION 0.4 • n=123 Participants
|
4.5 mg/dL
STANDARD_DEVIATION 0.5 • n=129 Participants
|
4.5 mg/dL
STANDARD_DEVIATION 0.5 • n=252 Participants
|
|
B-type natriuretic peptide (BNP)
|
56.6 pg/mg
n=123 Participants
|
54.0 pg/mg
n=129 Participants
|
55.9 pg/mg
n=252 Participants
|
|
Hemoglobin
|
13.6 g/dL
STANDARD_DEVIATION 1.8 • n=123 Participants
|
13.7 g/dL
STANDARD_DEVIATION 1.7 • n=129 Participants
|
13.6 g/dL
STANDARD_DEVIATION 1.8 • n=252 Participants
|
|
Non-diuretic antihypertensives
|
95 Participants
n=123 Participants
|
97 Participants
n=129 Participants
|
192 Participants
n=252 Participants
|
|
Non-insulin antidiabetic drugs
|
81 Participants
n=123 Participants
|
86 Participants
n=129 Participants
|
167 Participants
n=252 Participants
|
|
Lipid-lowering agents
|
76 Participants
n=123 Participants
|
79 Participants
n=129 Participants
|
155 Participants
n=252 Participants
|
|
Diuretics
|
48 Participants
n=123 Participants
|
45 Participants
n=129 Participants
|
93 Participants
n=252 Participants
|
|
Body mass index (BMI)
|
23.0 Kg/m^2
STANDARD_DEVIATION 3.9 • n=123 Participants
|
23.0 Kg/m^2
STANDARD_DEVIATION 3.7 • n=129 Participants
|
23.0 Kg/m^2
STANDARD_DEVIATION 3.8 • n=252 Participants
|
|
Systolic blood pressure (SBP)
|
140.2 mmHg
STANDARD_DEVIATION 19.8 • n=123 Participants
|
143.1 mmHg
STANDARD_DEVIATION 20.2 • n=129 Participants
|
141.7 mmHg
STANDARD_DEVIATION 20.0 • n=252 Participants
|
|
Heart rate
|
71.1 bpm
STANDARD_DEVIATION 13.9 • n=123 Participants
|
70.9 bpm
STANDARD_DEVIATION 11.1 • n=129 Participants
|
71.0 bpm
STANDARD_DEVIATION 12.6 • n=252 Participants
|
|
Peripheral oxygen saturation (spO2)
|
95.8 percentage of hemoglobin saturation
STANDARD_DEVIATION 2.4 • n=123 Participants
|
95.4 percentage of hemoglobin saturation
STANDARD_DEVIATION 3.0 • n=129 Participants
|
95.6 percentage of hemoglobin saturation
STANDARD_DEVIATION 2.7 • n=252 Participants
|
PRIMARY outcome
Timeframe: Within 48h after contrast administrationPopulation: Per-protocol population
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
Outcome measures
| Measure |
Oral Sodium Chloride
n=123 Participants
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.
|
Intravenous Sodium Chloride
n=129 Participants
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.
|
|---|---|---|
|
Number of Participants With Acute Kidney Injury During the First 48 Hours After Contrast Administration
|
5 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Oral Sodium Chloride
n=123 Participants
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.
|
Intravenous Sodium Chloride
n=129 Participants
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.
|
|---|---|---|
|
Estimated Glomerular Filtration Rate (eGFR) at 24h From Baseline
|
66.4 mL/min/1.73 m^2
Standard Deviation 18.9
|
68.8 mL/min/1.73 m^2
Standard Deviation 18.9
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Oral Sodium Chloride
n=123 Participants
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.
|
Intravenous Sodium Chloride
n=129 Participants
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.
|
|---|---|---|
|
Estimated Glomerular Filtration Rate (eGFR) at 48h From Baseline
|
66.1 mL/min/1.73 m^2
Standard Deviation 19.7
|
67.9 mL/min/1.73 m^2
Standard Deviation 19.6
|
SECONDARY outcome
Timeframe: 24 hours from contrast administration (baseline)Serum creatinine at 24 hours from contrast administration (baseline), as an secondary efficacy laboratory assessment.
Outcome measures
| Measure |
Oral Sodium Chloride
n=123 Participants
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.
|
Intravenous Sodium Chloride
n=129 Participants
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.
|
|---|---|---|
|
Serum Creatinine at 24h From Baseline
|
1.10 mg/dL
Standard Deviation 0.33
|
1.02 mg/dL
Standard Deviation 0.29
|
SECONDARY outcome
Timeframe: 48 hours from contrast administration (baseline)Serum creatinine at 48 hours from contrast administration (baseline), as an secondary efficacy laboratory assessment.
Outcome measures
| Measure |
Oral Sodium Chloride
n=123 Participants
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.
|
Intravenous Sodium Chloride
n=129 Participants
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.
|
|---|---|---|
|
Serum Creatinine at 48h From Baseline
|
1.10 mg/dL
Standard Deviation 0.36
|
1.04 mg/dL
Standard Deviation 0.31
|
SECONDARY outcome
Timeframe: 24 hours from contrast administration (baseline)Cystatin C at 24 hours from contrast administration (baseline), as an secondary efficacy laboratory assessment.
Outcome measures
| Measure |
Oral Sodium Chloride
n=123 Participants
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.
|
Intravenous Sodium Chloride
n=129 Participants
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.
|
|---|---|---|
|
Cystatin C at 24h From Baseline
|
1.38 mg/dL
Standard Deviation 0.44
|
1.33 mg/dL
Standard Deviation 0.46
|
SECONDARY outcome
Timeframe: 48 hours from contrast administration (baseline)Cystatin C at 48 hours from contrast administration (baseline), as an secondary efficacy laboratory assessment.
Outcome measures
| Measure |
Oral Sodium Chloride
n=123 Participants
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.
|
Intravenous Sodium Chloride
n=129 Participants
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.
|
|---|---|---|
|
Cystatin C at 48h From Baseline
|
1.36 mg/dL
Standard Deviation 0.43
|
1.36 mg/dL
Standard Deviation 0.46
|
SECONDARY outcome
Timeframe: 24 hours from contrast administration (baseline)Albumin-to-creatinine ratio at 24 hours from contrast administration (baseline), as an secondary efficacy laboratory assessment.
Outcome measures
| Measure |
Oral Sodium Chloride
n=123 Participants
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.
|
Intravenous Sodium Chloride
n=129 Participants
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.
|
|---|---|---|
|
Albumin-to-creatinine Ratio at 24h From Baseline
|
17.2 mg/g
Interval 8.3 to 72.0
|
17.0 mg/g
Interval 9.3 to 65.5
|
SECONDARY outcome
Timeframe: 48 hours from contrast administration (baseline)Albumin-to-creatinine ratio at 48 hours from contrast administration (baseline), as an secondary efficacy laboratory assessment.
Outcome measures
| Measure |
Oral Sodium Chloride
n=123 Participants
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.
|
Intravenous Sodium Chloride
n=129 Participants
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.
|
|---|---|---|
|
Albumin-to-creatinine Ratio at 48h From Baseline
|
17.6 mg/g
Interval 9.0 to 69.2
|
18.2 mg/g
Interval 9.0 to 50.1
|
SECONDARY outcome
Timeframe: 24 hours from contrast administration (baseline)Urea at 24 hours from contrast administration (baseline), as an secondary efficacy laboratory assessment.
Outcome measures
| Measure |
Oral Sodium Chloride
n=123 Participants
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.
|
Intravenous Sodium Chloride
n=129 Participants
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.
|
|---|---|---|
|
Urea at 24h From Baseline
|
43.7 mg/dL
Standard Deviation 18.7
|
42.2 mg/dL
Standard Deviation 18.2
|
SECONDARY outcome
Timeframe: 48 hours from contrast administration (baseline)Urea at 48 hours from contrast administration (baseline), as an secondary efficacy laboratory assessment.
Outcome measures
| Measure |
Oral Sodium Chloride
n=123 Participants
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.
|
Intravenous Sodium Chloride
n=129 Participants
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.
|
|---|---|---|
|
Urea at 48h From Baseline
|
46.0 mg/dL
Standard Deviation 19.5
|
43.5 mg/dL
Standard Deviation 20.1
|
SECONDARY outcome
Timeframe: 24 hours from contrast administration (baseline)Serum sodium at 24 hours from contrast administration (baseline), as an secondary efficacy laboratory assessment.
Outcome measures
| Measure |
Oral Sodium Chloride
n=123 Participants
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.
|
Intravenous Sodium Chloride
n=129 Participants
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.
|
|---|---|---|
|
Serum Sodium at 24h From Baseline
|
139.4 mg/dL
Standard Deviation 2.6
|
139.3 mg/dL
Standard Deviation 2.6
|
SECONDARY outcome
Timeframe: 48 hours from contrast administration (baseline)Serum sodium at 48 hours from contrast administration (baseline), as an secondary efficacy laboratory assessment.
Outcome measures
| Measure |
Oral Sodium Chloride
n=123 Participants
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.
|
Intravenous Sodium Chloride
n=129 Participants
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.
|
|---|---|---|
|
Serum Sodium at 48h From Baseline
|
139.2 mg/dL
Standard Deviation 2.7
|
139.4 mg/dL
Standard Deviation 2.6
|
SECONDARY outcome
Timeframe: 24 hours from contrast administration (baseline)Serum potassium at 24 hours from contrast administration (baseline), as an secondary efficacy laboratory assessment.
Outcome measures
| Measure |
Oral Sodium Chloride
n=123 Participants
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.
|
Intravenous Sodium Chloride
n=129 Participants
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.
|
|---|---|---|
|
Serum Potassium at 24h From Baseline
|
4.4 mg/dL
Standard Deviation 0.4
|
4.4 mg/dL
Standard Deviation 0.5
|
SECONDARY outcome
Timeframe: 48 hours from contrast administration (baseline)Serum potassium at 48 hours from contrast administration (baseline), as an secondary efficacy laboratory assessment.
Outcome measures
| Measure |
Oral Sodium Chloride
n=123 Participants
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.
|
Intravenous Sodium Chloride
n=129 Participants
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.
|
|---|---|---|
|
Serum Potassium at 48h From Baseline
|
4.4 mg/dL
Standard Deviation 0.4
|
4.5 mg/dL
Standard Deviation 0.5
|
Adverse Events
Oral Sodium Chloride
Serious events: 0 serious events
Other events: 31 other events
Deaths: 0 deaths
Intravenous Sodium Chloride
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Oral Sodium Chloride
n=134 participants at risk
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.
|
Intravenous Sodium Chloride
n=137 participants at risk
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.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
9.7%
13/134 • Within 48 hours from contrast administration (baseline).
Adverse events were registered, including severity and relationship with study medication.
|
0.00%
0/137 • Within 48 hours from contrast administration (baseline).
Adverse events were registered, including severity and relationship with study medication.
|
|
Gastrointestinal disorders
Vomiting
|
7.5%
10/134 • Within 48 hours from contrast administration (baseline).
Adverse events were registered, including severity and relationship with study medication.
|
0.00%
0/137 • Within 48 hours from contrast administration (baseline).
Adverse events were registered, including severity and relationship with study medication.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
2.2%
3/134 • Within 48 hours from contrast administration (baseline).
Adverse events were registered, including severity and relationship with study medication.
|
0.00%
0/137 • Within 48 hours from contrast administration (baseline).
Adverse events were registered, including severity and relationship with study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/134 • Within 48 hours from contrast administration (baseline).
Adverse events were registered, including severity and relationship with study medication.
|
1.5%
2/137 • Within 48 hours from contrast administration (baseline).
Adverse events were registered, including severity and relationship with study medication.
|
|
General disorders
Malaise/asthenia
|
0.75%
1/134 • Within 48 hours from contrast administration (baseline).
Adverse events were registered, including severity and relationship with study medication.
|
0.73%
1/137 • Within 48 hours from contrast administration (baseline).
Adverse events were registered, including severity and relationship with study medication.
|
|
Nervous system disorders
Headache
|
0.75%
1/134 • Within 48 hours from contrast administration (baseline).
Adverse events were registered, including severity and relationship with study medication.
|
0.00%
0/137 • Within 48 hours from contrast administration (baseline).
Adverse events were registered, including severity and relationship with study medication.
|
|
Musculoskeletal and connective tissue disorders
Leg cramps
|
0.75%
1/134 • Within 48 hours from contrast administration (baseline).
Adverse events were registered, including severity and relationship with study medication.
|
0.00%
0/137 • Within 48 hours from contrast administration (baseline).
Adverse events were registered, including severity and relationship with study medication.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.75%
1/134 • Within 48 hours from contrast administration (baseline).
Adverse events were registered, including severity and relationship with study medication.
|
0.00%
0/137 • Within 48 hours from contrast administration (baseline).
Adverse events were registered, including severity and relationship with study medication.
|
|
Immune system disorders
Allergic reaction to contrast
|
0.75%
1/134 • Within 48 hours from contrast administration (baseline).
Adverse events were registered, including severity and relationship with study medication.
|
0.00%
0/137 • Within 48 hours from contrast administration (baseline).
Adverse events were registered, including severity and relationship with study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/134 • Within 48 hours from contrast administration (baseline).
Adverse events were registered, including severity and relationship with study medication.
|
0.73%
1/137 • Within 48 hours from contrast administration (baseline).
Adverse events were registered, including severity and relationship with study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Chest tightness
|
0.00%
0/134 • Within 48 hours from contrast administration (baseline).
Adverse events were registered, including severity and relationship with study medication.
|
0.73%
1/137 • Within 48 hours from contrast administration (baseline).
Adverse events were registered, including severity and relationship with study medication.
|
|
Infections and infestations
Infection
|
0.00%
0/134 • Within 48 hours from contrast administration (baseline).
Adverse events were registered, including severity and relationship with study medication.
|
0.73%
1/137 • Within 48 hours from contrast administration (baseline).
Adverse events were registered, including severity and relationship with study medication.
|
Additional Information
Coordinator of Research Support Unit, Internal Medicine Dept.
Hospital Universitario Ramón y Cajal, IRYCIS
Phone: 0034913369082
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place