No registrations found.
ID
NL-OMON25782
Source
Nationaal Trial Register
Brief title
CarCIN-trial
Health condition
- contrast induced nephropathy
- aortic valve stenosis
Sponsors and support
Primary sponsor
:
Academic Medical Center (AMC) Amsterdam, Department of Cardiology
Source(s) of monetary or material Support
:
Academic Medical Center (AMC) Amsterdam, Department of Cardiology
Intervention
Outcome measures
Primary outcome
Mean increase in level of serum creatinine 2-5 days after contrast administration
Secondary outcome
1) acute kidney injury defined as an increase in serum creatinine of >25% or 44 umol 2-5 days after contrast administration,
2) need for renal replacement therapy
Intervention
Patients will be randomised on a 1:1 ratio in two different hydration protocols:
Arm 1) 1 hour l sodiumbicarbonate (NaHCO3, 1.4%, 3 ml/kg/1hour))
or
Arm 2) a 24 hour saline (NaCl 0.9%, 1 ml/kg/hour)
Public
M.S. van Mourik
P.O. Box 22660
Amsterdam 1100 DD
The Netherlands
+31 20 56 65204
m.s.vanmourik@amc.uva.nl
P.O. Box 22660
Amsterdam 1100 DD
The Netherlands
+31 20 56 65204
m.s.vanmourik@amc.uva.nl
Scientific
M.S. van Mourik
P.O. Box 22660
Amsterdam 1100 DD
The Netherlands
+31 20 56 65204
m.s.vanmourik@amc.uva.nl
P.O. Box 22660
Amsterdam 1100 DD
The Netherlands
+31 20 56 65204
m.s.vanmourik@amc.uva.nl
Inclusion criteria
- Patient is planned for Contrast enhanced CT and/or TAVI-procedure
- eGFR < 60 ml/min/1.73m^2
- written informed consent
Exclusion criteria
- M. Kahler / M. Waldenström
-
Design
Study type
:
Interventional
Intervention model
:
Parallel
Allocation
:
Randomized controlled trial
Masking
:
Open (masking not used)
Control
:
Active
Recruitment
NL
Recruitment status
:
Other
Start date (anticipated)
:
Enrollment
:
80
Type
:
Unknown
Positive opinion
Date
:
Application type
:
First submission
Followed up by the following (possibly more current) registration
ID: 43732
Bron: ToetsingOnlineOther (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL4769 |
| NTR-old | NTR5014 |
| CCMO | NL50955.018.14 |
| OMON | NL-OMON43732 |