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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-003696-18 | EudraCT Number |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | No Intervention | Patients who don't follow a special diet. | |
| Diet Group | Other | Patients who subsist on a special diet. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diet | Dietary Supplement | Patients receive special diet 4 days prior to contrast-agent administration. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rise of serum creatinine in mg/dl 48 hours after begin of coronary intervention (contrast agent administration) | Baseline to 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Rise of serum creatinine in mg/dl 24 hours after begin of coronary intervention. | Baseline to 24 hours | |
| Neutrophile-Gelatinase associated Lipocaline (NGAL in µg/l) in urine 24 hours after begin of coronary intervention. | Baseline to 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of CIN (contrast-agent induced nephropathy) with rise of serum creatinine about ≥ 0,5 mg/dl or ≥ 25% of initial value with 48 hours. | Baseline to 48 hours. | |
| Occurrence of acute renal failure corresponding KDIGO I, II, III | Baseline to 4 weeks |
Inclusion Criteria:
men and women 18 years of age or older
caucasian origin
scheduled coronary angiography
indication for coronary angiography is determined by the referring physician
Patient and/or legal guardian must be willing and able to give written informed consent
at least one of the following risk factors:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Volker Burst, MD | University of Cologne | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Cologne | Cologne | 50937 | Germany |
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| ID | Term |
|---|---|
| D004032 | Diet |
| ID | Term |
|---|---|
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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One arm with controlled diet, second arm as control group with no diet.
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| Cystatin C in Plasma (mg/l) 24 hours after begin of coronary intervention. | Baseline to 24 hours |
| Necessity of dialysis up to 4 weeks after coronary intervention. | Baseline to 4 weeks. |
| Mortality at timepoint 4 weeks after coronary intervention. | Baseline to 4 weeks. |
| Hospitalization up to 4 weeks after coronary intervention. | Baseline to 4 weeks. |
| Urea (mg/dl), white blood cells (/µl) LDH (U/l), CRP (mg/l), CK (U/l), CK-MB (U/l und %) at timepoint 24 and 48 hours after coronary angiography | Baseline to 24 and 48 hours |