Bicarbonate v Saline to Prevent Contrast Nephropathy

NCT00384995 | Terminated Phase 4 DMC

• 1 other identifier: PR021676
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 5

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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

Study Arms (2)

Bicarbonate

EXPERIMENTAL

Bicarbonate solution infusion

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

Saline

ACTIVE COMPARATOR

Standard volume expansion

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

Interventions

0.9% (154 mEq/L) IV Sodium Chloride DRUG

Saline solution

Also known as: Sodium Chloride

Saline

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

Bicarbonate solution

Also known as: Sodium Bicarbonate

Bicarbonate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Italian Society of Nephrology: lead
• European Commission: collaborator
• Memorial University of Newfoundland: collaborator

Study Sites (5)

Spedali Civili di Brescia

Brescia, 25100, Italy

Location

Ospedale Ferrarotto

Catania, 95100, Italy

Location

P.O. Uboldo

Cernusco sul Naviglio, 20063, Italy

Location

Azienda Istituti Ospitalieri di Cremona

Cremona, 26100, Italy

Location

IRCCS Policlinico San Donato

San Donato, 20097, Italy

Location

Related Publications (2)

• 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.

  PMID: 15150204 BACKGROUND

• 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.

  PMID: 17943084 DERIVED

MeSH Terms

Conditions

Acute Kidney Injury; Renal Insufficiency, Chronic; Kidney Failure, Chronic; Cardiovascular Diseases

Interventions

Sodium Chloride; Sodium Bicarbonate

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Bicarbonates; Carbonates; Carbonic Acid; Carbon Compounds, Inorganic

Study Officials

• Pietro Ravani, MD, MSc

  Italian Society of Nephrology

  PRINCIPAL INVESTIGATOR

• Brendan BJ Barrett, MD, MSc

  Memorial University of Newfoundland

  STUDY CHAIR

• Ferruccio Conte, MD

  Italian Society of Nephrology

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 5, 2006
• First Posted: October 6, 2006
• Study Start: December 1, 2006
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: December 1, 2010

Record last verified: 2010-11

Locations

IT (5)