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Sponsors and Collaborators: |
Italian Society of Nephrology European Commission Memorial University of Newfoundland |
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Information provided by: | Italian Society of Nephrology |
ClinicalTrials.gov Identifier: | NCT00384995 |
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.
Condition | Intervention | Phase |
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Kidney Failure, Acute Contrast Media |
Drug: 0.9% (154 mEq/L) IV Sodium Chloride Drug: 1/6 M (166 mEq/L) IV Sodium Bicarbonate |
Phase IV |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Phase 4 Study of Bicarbonate Versus Saline Infusion Therapy to Prevent Contrast Induced Nephropathy (CAN-IT PREVENT Protocol) |
Estimated Enrollment: | 1510 |
Study Start Date: | December 2006 |
Estimated Study Completion Date: | December 2008 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Pietro Ravani, MD, MSc | 1-709-777 ext 8028 | pietro.ravani@med.mun.ca |
Contact: Pietro Ravani, MD, MSc | 39-0372-405 ext 379 | p.ravani@ospedale.cremona.it |
Italy | |
Azienda Istituti Ospitalieri di Cremona | Recruiting |
Cremona, Italy, 26100 | |
Contact: Fabio Malberti, MD +30-0372-405 ext 380 f.malberti.aioc@e-cremona.it | |
Principal Investigator: Fabio Malberti, MD | |
Spedali Civili di Brescia | Not yet recruiting |
Brescia, Italy, 25100 | |
Contact: Francesco Scolari, MD +39-030-3995 ext 628 fscolar@tin.it | |
Principal Investigator: Giovanni Cancarini, MD | |
P.O. Uboldo | Not yet recruiting |
Cernusco sul Naviglio, Italy, 20063 | |
Contact: Ferruccio Conte, MD +39-02-9236 ext 0320 contefc@tin.it | |
Principal Investigator: Ferruccio Conte, MD |
Principal Investigator: | Pietro Ravani, MD, MSc | Italian Society of Nephrology |
Study Chair: | Brendan BJ Barrett, MD, MSc | Memorial University of Newfoundland |
Study Chair: | Ferruccio Conte, MD | Italian Society of Nephrology |
Study ID Numbers: | PR021676 |
Study First Received: | October 5, 2006 |
Last Updated: | December 5, 2006 |
ClinicalTrials.gov Identifier: | NCT00384995 History of Changes |
Health Authority: | Italy: Ministry of Health |
Contrast Induced Nephropathy Chronic Kidney Disease Acute Renal Failure End-stage Renal Disease Cardiovascular diseases |
Coronary catheterization Percutaneous coronary intervention Intra-arterial angiography Bicarbonate Saline |
Renal Insufficiency Urologic Diseases Renal Insufficiency, Chronic Kidney Failure, Chronic |
Renal Insufficiency, Acute Kidney Failure, Acute Kidney Diseases Kidney Failure |
Renal Insufficiency Urologic Diseases Renal Insufficiency, Acute |
Kidney Failure, Acute Kidney Diseases Kidney Failure |