Renal Failure Chronic Contrast Induced Clinical Trial
Official title:
Phase 4 Study of Effect of a Pre-interventional Calorie Restriction on Renal Function After Administration of Contrast Agent in Patients at Risk
The aim of this study is to assess the effect of a diet prior to administration of contrast
agent in terms of a preventive procedure which leads to an attenuation of the
contrast-induced nephropathy (CIN).
Patients with a known kidney disease are especially at risk. A potential beneficial effect of
a diet prior to intervention has been shown in investigations in mammals, therefore this
study will investigate if a pre-interventional diet in patients with known kidney disease and
scheduled contrast agent examination can attenuate or prevent a post-interventional loss of
kidney function.
Patients with contrast agent examinations are at risk for contrast-induced nephropathy (CIN)
and in succession acute renal failure which is associated with significant morbidity and
mortality. None of the currently used preventive procedures show a benefit in terms of a
CIN-prevention.
Experimental data suggests, that a pre-interventional caloric restriction might provide
kidney protection in this context. This clinical trial investigates if this phenomenon is
also applicable in humans. Patients with increased risk for a post-interventional renal
failure due to known chronic kidney disease are randomized in 2 groups. Patients of the diet
group receive a calorie restriction to 60% of the calculated daily energy rate from day -4
until day -1 (included) pre-intervention (day 0 corresponds to day of intervention). Patients
of the control group receive alimentation ad libitum.
Primary objective is the increase of serum creatinine in mg/dl 48 h after begin of
intervention in comparison to baseline value obtained in the morning of the day of
intervention (day 0) in order to analyse if a pre-interventional calorie restriction as a
preventive strategy leads to an attenuation of post-interventioal kidney injury.
Hypothesis: A four day calorie restriction reduces the increase of serum creatinine after
administration of contrast agent in patients with known chronic kidney disease.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT01064895 -
Post-Market Observation Study of Intra-renal Drug Delivery (PROVIDE)
|
N/A |