|- candidate number||6827|
|- NTR Number||NTR2149|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||23-dec-2009|
|- Secondary IDs||NL27494.058.09 ABR File Number|
|- Public Title||Sodium Bicarbonate versus Saline for the prevention of Contrast Induced Nephropathy in patients undergoing computed tomography.|
|- Scientific Title||Sodium Bicarbonate versus Saline for the prevention of Contrast Induced Nephropathy in patients undergoing computed tomography.|
|- ACRONYM||The Salina Study|
|- hypothesis||H0= 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) studied||Prevention, Contrast Induced Nephropathy , Computed tomography, Hydration|
|- Inclusion criteria||1. eGFR < 45 ml/min/1.73m2; |
2. eGFR < 60 ml/min/1.73m2 and diabetes mellitus.
|- Exclusion criteria||1. Age < 18 years;|
2. Exposure to radiographic contrast media within 7 days;
4. Allergy for low osmolar contrast media.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||7-feb-2010|
|- planned closingdate||7-feb-2012|
|- Target number of participants||574|
|- Interventions||Group 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 outcome||Mean increase in serum creatinine 2-4 days after contrast administration.|
|- Secondary outcome||1. 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.
|- Timepoints||1. 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 site||www.msbi.nl/salina|
|- status||stopped: trial finished|
|- CONTACT FOR PUBLIC QUERIES|| Judith Kooiman|
|- CONTACT for SCIENTIFIC QUERIES|| Judith Kooiman|
|- Sponsor/Initiator ||Leiden University Medical Center (LUMC)|
(Source(s) of Monetary or Material Support)
|Leiden University Medical Center (LUMC)|
|- Brief summary||N/A|
|- Main changes (audit trail)|
|- RECORD||23-dec-2009 - 27-sep-2012|