• Evaluation of the incidence of CIN after CT-angiography with a hydration regime during 1 hour with sodium bicarbonate compaired to a hydration regime with saline during 24 hours.• Furthermore the risk for developing CIN after CT-angiography is…
ID
Source
Brief title
Condition
- Coagulopathies and bleeding diatheses (excl thrombocytopenic)
- Nephropathies
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
• CIN defined as an increase in serum creatinine > 25% or > 44 µmol/l after 3-5
days.
• CIN defined as an increase in serum creatinine > 25% or > 44 µmol/l after 2
months or an indication for dialysis.
Secondary outcome
• loss of renal function, calculated as an absolute decrease in eGFR.
Background summary
Contrast induced nephropathy (CIN) can occur after injecting radiographic low
osmolair contrast media, which is used for CT-angiography. Patients with renal
impairment, as specially in combination with diabetis mellitus are at risk for
developing CIN. In most of the patients renal function recovers in 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 posthydration treatment each during 12
hours with 0.9% saline 1 ml/hour/kg bodyweight. This results in two days
hospitalisation 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 CT-angiography. This
hydration regime is studied in patient groups undergoing coronairy angiography.
There is no consensus of the exact implemtation of hydration regimes with
sodium bicarbonate.
Study objective
• Evaluation of the incidence of CIN after CT-angiography with a hydration
regime during 1 hour with sodium bicarbonate compaired to a hydration regime
with saline during 24 hours.
• Furthermore the risk for developing CIN after CT-angiography is studied for
both hydration regimes.
Study design
This is a prospective multi-center cohort study.
Intervention
• Group 1: Prehydratie with sodium bicarbonate 1.4% 3 ml/kg bodyweight 1 hour
prior to CT-angiography.
• Group 2: Pre- and posthydration with saline 0.9% 1 ml/hour/kg bodyweight both
during 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 CT-angiography. In this study patients
will receive one extra vena punction prior to CT-angiography and are asked for
one urine sample after CT-angiography.
The CBO advises to check renal function 3 to 5 days after CT-angiography of all
patients at risk for CIN. In this study we will ask for one extra venapunction
and urine sample after 3 to 5 days and one extra venapunction after 8 days.
If renal function is decreased after 3 to 5 days according to the defenition of
CIN, patients are asked to come back after 2 months for some extra bloodwork to
determine whether there kidney function is restored or not. This is not
clinical practice.
Participation in this study results in 1 extra hospital visit if CIN is
diagnosed after 3 to 5 days. After 8 days one extra venapuncture is asked.
Patients will probably have advantagde of this accurate monitoring of kidney
function.
Albinusdreef 2
2333 ZA
NL
Albinusdreef 2
2333 ZA
NL
Listed location countries
Age
Inclusion criteria
eGFR < 45 ml/min
eGFR < 60 ml/min and diabetis mellitus
Exclusion criteria
- age < 18 years;
- exposure to radiographic contrast media within 7 days;
- pregnancy;
- allergy for low osmolar 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 | NL27494.058.09 |
| OMON | NL-OMON21374 |