Evaluation of the rise in serum creatinine and the incidence of CIN following angiography in patients treated with a short hydration regime during 1 hour with sodium bicarbonate compared to a hydration regime with saline during 6-24 hours.
ID
Source
Brief title
Condition
- Nephropathies
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
• mean rise in serum creatinine 2-4 days after angiography
Secondary outcome
• CIN defined as an increase in serum creatinine > 25% or > 44 µmol/l after 2-4
days;
• CIN defined as an increase in serum creatinine > 25% or > 44 µmol/l after 2
months;
• Indication for dialysis due too CIN;
• Congestive heart failure due to rapid volume expansion with an indication for
treatment with diuretics.
Background summary
Contrast induced nephropathy (CIN) can occur after injection of radiographic
low osmolar contrast media, which are frequently used for angiography.
Patients with renal impairment, as specially in combination with diabetis
mellitus are at risk for developing CIN. In the majority of the patients renal
function will recover within two months after the diagnosis of CIN.
A consensus of the CBO (Dutch Central Guidance Institute) advises to give
patients at risk for CIN a pre and post hydration treatment each during 3-12
hours with 0.9% NaCl 1000 mL. This results in a maximum of two days
hospitalization for a large group of patients. An alternative hydration regime
is a short regime with sodium bicarbonate 1.4% 3 ml/hour/kg bodyweight, 1 hour
prior and 6 hours after angiography. This hydration regime is studied in
patient groups undergoing coronary angiography. There is no consensus on the
exact implantation of hydration regimes with sodium bicarbonate and post
hydration might not be necessary.
Study objective
Evaluation of the rise in serum creatinine and the incidence of CIN following
angiography in patients treated with a short hydration regime during 1 hour
with sodium bicarbonate compared to a hydration regime with saline during 6-24
hours.
Study design
This is a prospective multi-center cohort study.
Intervention
• Group 1: Pre hydration with sodium bicarbonate 1.4% 250 mL 1 hour prior to
angiography.
• Group 2: Pre and post hydration with saline 0.9% 1000 ml each during 3-12
hours.
Study burden and risks
The amount of stress on the patient for this study is very limited.
Renal function is routinely measured prior to angiography. In this study
patients will receive one extra vena punction prior to and 4 hours after
angiography and are asked for urine samples. However, when possible, blood work
will be extracted from the IV needle to spare a patient from extra vena
punctions.
The CBO advises to check renal function 2 to 4 days after angiography of all
patients at risk for CIN. During this routine check we will ask for one extra
serum sample (10 ml).
If renal function is decreased after 2 to 4 days according to the definition of
CIN, patients are asked to come back after 2 months for some extra blood work
to determine whether their kidney function is restored. This is not clinical
practice. Participation in this study results in 1 extra hospital visit if CIN
is diagnosed after 2 to 4 days. Patients will probably have advantage of this
accurate monitoring of renal function.
Albinusdreef 2
2333 ZA
NL
Albinusdreef 2
2333 ZA
NL
Listed location countries
Age
Inclusion criteria
- patients undergoing angiography with intra arterial contrast administration
- eGFR (estimated glomerular filtration rate) < 60 ml/min
Exclusion criteria
- age < 18 years
- heamodynamic instability
- pregnancy
- allergy for contrast media
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL33992.058.10 |