Bicarbonate v Saline to Prevent Contrast Nephropathy

NCT ID: NCT00384995

Last Updated: 2010-12-01

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 61 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-12-31
• Study Completion Date: 2009-07-31

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Bicarbonate

Bicarbonate solution infusion

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

Bicarbonate solution

Saline

Standard volume expansion

Group Type: ACTIVE_COMPARATOR

0.9% (154 mEq/L) IV Sodium Chloride

Intervention Type: DRUG

Saline solution

Interventions

0.9% (154 mEq/L) IV Sodium Chloride

Saline solution

Intervention Type: DRUG

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

Bicarbonate solution

Intervention Type: DRUG

Other Intervention Names

Sodium Chloride; Sodium Bicarbonate

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

European Commission

OTHER

Sponsor Role: collaborator

Memorial University of Newfoundland

OTHER

Sponsor Role: collaborator

Italian Society of Nephrology

OTHER

Sponsor Role: lead

Responsible Party

Italian Society of Nephrology

Principal Investigators

Pietro Ravani, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Italian Society of Nephrology

Brendan BJ Barrett, MD, MSc

Role: STUDY_CHAIR

Memorial University of Newfoundland

Ferruccio Conte, MD

Role: STUDY_CHAIR

Italian Society of Nephrology

Locations

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, , Italy

Countries

Italy

References

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.

Reference Type: BACKGROUND

PMID: 15150204 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 17943084 (View on PubMed)

Other Identifiers

PR021676

Identifier Type: -

Identifier Source: org_study_id