No registrations found.
ID
Source
Brief title
Health condition
Prevention, Contrast Induced Nephropathy, Computed Tomography, hydration
preventie, contrastnefropathie, CT-scan, hydratie
Sponsors and support
Intervention
Outcome measures
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.
Background summary
N/A
Study objective
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.
Study design
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).
Intervention
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.
Judith Kooiman
Leiden University Medical Center, Albinusdreef 2, Postzone C4-70
Leiden 2333 ZA
The Netherlands
+31 (0)71-526.20.85
j.kooiman@lumc.nl
Judith Kooiman
Leiden University Medical Center, Albinusdreef 2, Postzone C4-70
Leiden 2333 ZA
The Netherlands
+31 (0)71-526.20.85
j.kooiman@lumc.nl
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;
3. Pregnancy;
4. Allergy for low osmolar contrast media.
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL2032 |
| NTR-old | NTR2149 |
| CCMO | NL27494.058.09 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |
| OMON | NL-OMON38407 |