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Sodium Bicarbonate versus Saline for the prevention of Contrast Induced Nephropathy in patients undergoing computed tomography.


- candidate number6827
- NTR NumberNTR2149
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR23-dec-2009
- Secondary IDsNL27494.058.09 ABR File Number
- Public TitleSodium Bicarbonate versus Saline for the prevention of Contrast Induced Nephropathy in patients undergoing computed tomography.
- Scientific TitleSodium Bicarbonate versus Saline for the prevention of Contrast Induced Nephropathy in patients undergoing computed tomography.
- ACRONYMThe Salina Study
- hypothesisH0= Saline is inferior to sodium bicarbonate for the prevention of contrast induced nephropathy in patients undergoing computed tomography after intravenous contrast administration.
H1= Saline is noninferior to sodium bicarbonate for the prevention of contrast induced nephropathy in patients undergoing computed tomography after intravenous contrast administration.
- Healt Condition(s) or Problem(s) studiedPrevention, Contrast Induced Nephropathy , Computed tomography, Hydration
- Inclusion criteria1. eGFR < 45 ml/min/1.73m2;
2. eGFR < 60 ml/min/1.73m2 and diabetes mellitus.
- Exclusion criteria1. Age < 18 years;
2. Exposure to radiographic contrast media within 7 days;
3. Pregnancy;
4. Allergy for low osmolar contrast media.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 7-feb-2010
- planned closingdate7-feb-2012
- Target number of participants574
- InterventionsGroup 1: Sodium Bicarbonate 1.4% 1 hour prior to computed tomography 250 mL. No posthydration.
Group 2: Sodium Chloride 0.9% 1 ml/hr/kg bodyweight, during 12 hours for and after computed tomography.
- Primary outcomeMean increase in serum creatinine 2-4 days after contrast administration.
- Secondary outcome1. Contrast induced nephropathy defined as an increase in serum creatinine > 25% or > 44 umol/L 2-4 days after contrast administration;
2. Chronic renal impairment defined as an increase in serum creatinine > 25% or > 44 umol/L 2 months after contrast administration;
3. Development of an indication for renal replacement therapy.
- Timepoints1. 4 hours after computed tomography;
2. 3 (+/- 1 day) after computed tomography;
3. 2 months after computed tomography when contrast induced nephropathy is diagnosed after 3 days (2).
- Trial web sitewww.msbi.nl/salina
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIES Judith Kooiman
- CONTACT for SCIENTIFIC QUERIES Judith Kooiman
- Sponsor/Initiator Leiden University Medical Center (LUMC)
- Funding
(Source(s) of Monetary or Material Support)
Leiden University Medical Center (LUMC)
- PublicationsN/A
- Brief summaryN/A
- Main changes (audit trail)
- RECORD23-dec-2009 - 27-sep-2012


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