Clinical trial NCT00384995: Bicarbonate v Saline to Prevent Contrast Nephropathy
Official title: Phase 4 Study of Bicarbonate Versus Saline Infusion Therapy to Prevent Contrast Induced Nephropathy (CAN-IT PREVENT Protocol)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Kidney Failure, Acute
Contrast Media
Keywords: 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
Lead sponsor: Italian Society of Nephrology
Sponsor class: OTHER
Collaborators: name: European Commission
name: Memorial University of Newfoundland
First posted: 2006-10-06
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Booked for cardiac or other non-renal arteriography
* Pre-existing reduced kidney function: Serum Creatinine \>= 1.3 \& \<= 4 mg/dl (female gender) or \>= 1.5 \& \<= 5 mg/dl (male gender)
* Age \> 18 years

Exclusion Criteria:

* GFR MDRD estimate \< 15 ml/min/m2
* End-stage renal disease already on dialysis
* Known current Acute Kidney Failure with serum creatinine rise of \> 0.5 mg/dl within 24 hours
* Pulmonary edema - current or within 48 hours
* Clinically relevant ascites, edema or other fluid overload
* Uncontrolled hypertension (\> 165 mmHg systolic, or \> 105 mmHg diastolic)
* Hemodynamically unstable patient requiring IV nitroglycerine, or IV fluid or inotropes for blood pressure support
* Emergency (unplanned) angiography
* IV contrast procedure
* Exposure to iodinated radiocontrast within 3 days prior to study
* Prior anaphylactoid reaction to contrast
* Planned administration of N-acetylcysteine
* Planned administration of dopamine, fenoldopam or mannitol
* Current pregnancy

Primary outcomes:
measure: 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.
timeFrame: 48-72 hours
Secondary outcomes:
measure: Group mean change in serum creatinine
timeFrame: 48-72 hours
measure: Days in hospital within the week post contrast
timeFrame: One week
measure: Requirement for dialysis
timeFrame: Two months
measure: Atheroembolic events
timeFrame: Two months
measure: Major adverse cardiovascular events
timeFrame: Two months
measure: Death
timeFrame: Two months
Other outcomes:
Locations:
city: Brescia
country: Italy
facility: Spedali Civili di Brescia
city: Catania
country: Italy
facility: Ospedale Ferrarotto
city: Cernusco sul Naviglio
country: Italy
facility: P.O. Uboldo
city: Cremona
country: Italy
facility: Azienda Istituti Ospitalieri di Cremona
city: San Donato
country: Italy
facility: IRCCS Policlinico San Donato
Study officials:
affiliation: Italian Society of Nephrology
name: Pietro Ravani, MD, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Memorial University of Newfoundland
name: Brendan BJ Barrett, MD, MSc
role: STUDY_CHAIR
affiliation: Italian Society of Nephrology
name: Ferruccio Conte, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.