Bicarbonate v Saline to Prevent Contrast Nephropathy

Sponsor

Italian Society of Nephrology (Other)

Overall Status

Terminated

CT.gov ID

NCT00384995

Collaborator

European Commission (Other), Memorial University of Newfoundland (Other)

Enrollment

Locations

Arms

Duration (Months)

12.2

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
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 4

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

61 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Dec 1, 2006

Actual Primary Completion Date :

Jul 1, 2009

Actual Study Completion Date :

Jul 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Bicarbonate Bicarbonate solution infusion	Drug: 1/6 M (166 mEq/L) IV Sodium Bicarbonate Bicarbonate solution Other Names: Sodium Bicarbonate
Active Comparator: Saline Standard volume expansion	Drug: 0.9% (154 mEq/L) IV Sodium Chloride Saline solution Other Names: Sodium Chloride

Arm

Intervention/Treatment

Experimental: Bicarbonate

Bicarbonate solution infusion

Drug: 1/6 M (166 mEq/L) IV Sodium Bicarbonate

Bicarbonate solution

Other Names:

Sodium Bicarbonate

Active Comparator: Saline

Standard volume expansion

Drug: 0.9% (154 mEq/L) IV Sodium Chloride

Saline solution

Other Names:

Sodium Chloride

Outcome Measures

Primary Outcome Measures

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]

Secondary Outcome Measures

Group mean change in serum creatinine [48-72 hours]
Days in hospital within the week post contrast [One week]
Requirement for dialysis [Two months]
Atheroembolic events [Two months]
Major adverse cardiovascular events [Two months]
Death [Two months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Spedali Civili di Brescia	Brescia	Italy	25100
2	Ospedale Ferrarotto	Catania	Italy	95100
3	P.O. Uboldo	Cernusco sul Naviglio	Italy	20063
4	Azienda Istituti Ospitalieri di Cremona	Cremona	Italy	26100
5	IRCCS Policlinico San Donato	San Donato	Italy	20097