Bicarbonate v Saline to Prevent Contrast Nephropathy

Kidney Failure, Acute Clinical Trial

Official title:

Phase 4 Study of Bicarbonate Versus Saline Infusion Therapy to Prevent Contrast Induced Nephropathy (CAN-IT PREVENT Protocol)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00384995
• Other study ID #: PR021676
• Status: Terminated
• Phase: Phase 4
• First received: October 5, 2006
• Last updated: November 29, 2010
• Start date: December 2006
• Est. completion date: July 2009

Study information

• Verified date: November 2010
• Source: Italian Society of Nephrology
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 61
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Acute Kidney Injury
• Contrast Media
• Kidney Diseases
• Kidney Failure, Acute
• Renal Insufficiency

Intervention

Drug:
• 0.9% (154 mEq/L) IV Sodium Chloride
Saline solution
• 1/6 M (166 mEq/L) IV Sodium Bicarbonate
Bicarbonate solution

Locations

Country	Name	City	State
Italy	Spedali Civili di Brescia	Brescia
Italy	Ospedale Ferrarotto	Catania
Italy	P.O. Uboldo	Cernusco sul Naviglio
Italy	Azienda Istituti Ospitalieri di Cremona	Cremona
Italy	IRCCS Policlinico San Donato	San Donato

Sponsors (3)

Lead Sponsor	Collaborator
Italian Society of Nephrology	European Commission, Memorial University of Newfoundland

Country where clinical trial is conducted

Italy, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Group mean change in serum creatinine		48-72 hours	No
Secondary	Days in hospital within the week post contrast		One week	No
Secondary	Requirement for dialysis		Two months	No
Secondary	Atheroembolic events		Two months	No
Secondary	Major adverse cardiovascular events		Two months	No
Secondary	Death		Two months	No