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Contrast-induced nephropathy (CIN) is the third most frequent cause of hospital-acquired acute renal failure. Different regimes in the prophylaxis of CIN have been investigated in the last years. Recent Meta-analysis show a reduced incidence of CIN when theophylline is administered to the patients especially in patients with already existing renal impairment. Furthermore hydration with bicarbonate seems to to be superior to hydration with sodium chloride alone. The combination of the two prophylaxis has not been investigated yet.
Aim of this prospective randomized trial is to investigate the effect of hydration with sodium bicarbonate compared to saline in addition to theophylline prophylaxis which all patients receive.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bicarbonate and theophylline | Experimental | Hydration with bicarbonate in addition to theophylline |
|
| Sodium and theophylline | Active Comparator | Hydration with sodium chloride in addition to theophylline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydration with bicarbonate in addition to theophylline | Other | 0.154-molar sodium bicarbonate; 3 ml per kg bodyweight (maximum 330 ml) one hour before contrast exposure; additionally 200 mg theophylline as a short infusion; after contrast application hydration with another 1 ml per kg bodyweight per hour (maximum 110 ml per hour) for 6 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Contrast induced nephropathy | Raise in serum creatinine of ≥25% or ≥0.5 mg/dl | 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Change of serum creatinine levels over time | 48 hours | |
| Change of creatinine clearance over time | 48 hours | |
| Change in blood pH |
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Inclusion Criteria:
Increased risk for contrast induced nephropathy defined as:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wolfgang Huber, M.D. | 2. Medizinische Klinik, Klinikum rechts der Isar der Technischen Universität München | Principal Investigator |
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| ID | Term |
|---|---|
| D001639 | Bicarbonates |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002254 | Carbonates |
| D002255 | Carbonic Acid |
| D017554 | Carbon Compounds, Inorganic |
| D007287 | Inorganic Chemicals |
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|
| Hydration with sodium chloride in addition to theophylline | Other | 0.9% sodium chloride; 3 ml per kg bodyweight (maximum 330 ml) one hour before contrast exposure; additionally 200 mg theophylline as a short infusion; after contrast application hydration with another 1 ml per kg bodyweight per hour (maximum 110 ml per hour) for 6 hours |
|
| 48 hours |
| Change in blood bicarbonate-concentration | 48 hours |
| Change in blood sodium-concentration | 48 hours |
| Change in urine pH | 48 hours |
| Change in urine bicarbonate-concentration | 48 hours |
| Change in urine pH sodium-concentration | 48 hours |
| Incidence of patients with need for dialysis | The patients medical record was reviewed to determine whether dialysis was performed within 30 days after contrast media application. | 30 days |
| D000838 |
| Anions |
| D007477 | Ions |
| D004573 | Electrolytes |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D017670 | Sodium Compounds |