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| Name | Class |
|---|---|
| European Commission | OTHER |
| Memorial University of Newfoundland | OTHER |
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Slowing of kidney function occurs in a minority of people given dye during angiography. The purpose of this study is to compare two different types of fluid given into a vein to reduce the risk of kidney injury: salt in water or baking soda in water.
A decline in kidney function after contrast is associated with prolonged hospital stay, adverse cardiac events, and higher mortality both in hospital and in the long term. Deliberate administration of fluids is recommended to reduce the risk of contrast nephropathy. However, data to support specific recommendations are lacking and the optimal fluid regimen remains unclear.
It has been hypothesized that alkalinization of tubular fluid might be beneficial by reducing pH dependent free radical levels. A recent trial found a lower frequency of creatinine rise > 25% within two days of contrast with a 7 hour infusion of isotonic sodium bicarbonate than with saline infusion (Merten GJ, JAMA 2004). However, it remains to be proven that bicarbonate is superior as this trial has a number of methodological flaws.
Comparison: IV 1/6 M sodium bicarbonate OR IV 0.9% saline, each isotonic fluid given at the same rate of sodium administration (3.25 ml/Kg over 1 hour pre-contrast, followed by 1.1 ml/Kg/hr for 6 hours for bicarbonate; 3.5 ml/Kg over 1 hour pre-contrast, followed by 1.2 ml/Kg/hr for 6 hours for saline). Total infusion time 7 hours (for both). Maximum rate of fluid permitted is that for a body weight of 110 Kg. Intra-vascular iso- or low-osmolality contrast in the minimal dose needed to complete the required imaging.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bicarbonate | Experimental | Bicarbonate solution infusion |
|
| Saline | Active Comparator | Standard volume expansion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 0.9% (154 mEq/L) IV Sodium Chloride | Drug | Saline solution |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Development of contrast-induced nephropathy, CIN, defined as an increase in serum creatinine of 25% or more from pre-intervention baseline to within 48-72 hours after administration of the radiographic contrast. | 48-72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Group mean change in serum creatinine | 48-72 hours | |
| Days in hospital within the week post contrast | One week | |
| Requirement for dialysis |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pietro Ravani, MD, MSc | Italian Society of Nephrology | Principal Investigator |
| Brendan BJ Barrett, MD, MSc | Memorial University of Newfoundland | Study Chair |
| Ferruccio Conte, MD | Italian Society of Nephrology | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Spedali Civili di Brescia | Brescia | 25100 | Italy | |||
| Ospedale Ferrarotto |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15150204 | Background | Merten GJ, Burgess WP, Gray LV, Holleman JH, Roush TS, Kowalchuk GJ, Bersin RM, Van Moore A, Simonton CA 3rd, Rittase RA, Norton HJ, Kennedy TP. Prevention of contrast-induced nephropathy with sodium bicarbonate: a randomized controlled trial. JAMA. 2004 May 19;291(19):2328-34. doi: 10.1001/jama.291.19.2328. | |
| 17943084 | Derived |
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| ID | Term |
|---|---|
| D058186 | Acute Kidney Injury |
| D051436 | Renal Insufficiency, Chronic |
| D007676 | Kidney Failure, Chronic |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| D017693 | Sodium Bicarbonate |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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| 1/6 M (166 mEq/L) IV Sodium Bicarbonate | Drug | Bicarbonate solution |
|
|
| Two months |
| Atheroembolic events | Two months |
| Major adverse cardiovascular events | Two months |
| Death | Two months |
| Catania |
| 95100 |
| Italy |
| P.O. Uboldo | Cernusco sul Naviglio | 20063 | Italy |
| Azienda Istituti Ospitalieri di Cremona | Cremona | 26100 | Italy |
| IRCCS Policlinico San Donato | San Donato | 20097 | Italy |
| Ravani P, Tripepi G, Pecchini P, Mallamaci F, Malberti F, Zoccali C. Urotensin II is an inverse predictor of death and fatal cardiovascular events in chronic kidney disease. Kidney Int. 2008 Jan;73(1):95-101. doi: 10.1038/sj.ki.5002565. Epub 2007 Oct 17. |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D017670 |
| Sodium Compounds |
| D001639 | Bicarbonates |
| D002254 | Carbonates |
| D002255 | Carbonic Acid |
| D017554 | Carbon Compounds, Inorganic |