Bicarbonates Versus Saline for Contrast Induced Acute Kidney Injury Prevention in Intensive Care Unit

Contrast Induced Acute Kidney Injury Clinical Trial

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Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01636089
• Other study ID #: 2011-A00227-34
• Status: Completed
• Phase: Phase 3
• First received: February 15, 2012
• Last updated: February 2, 2015
• Start date: February 2012
• Est. completion date: January 2015

Study information

• Verified date: February 2015
• Source: University Hospital, Caen
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to compare bicarbonates versus saline for prevention of contrast induced acute kidney injury in critically ill patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patient > 18 years old

• in intensive care unit since 24h and for up to 48 hours

• with contrast medium injection

Exclusion Criteria:

• patient under renal replacement therapy

• rise in creatinine > 26µmol/L within 48hours

• anuria within 12 hours

• cardiogenic pulmonary oedema

• pH > 7.50 or kaliemia < 3mmol/L

• pregnancy

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Acute Kidney Injury
• Contrast Induced Acute Kidney Injury

Intervention

Drug:
• bicarbonates
sodium bicarbonates 1,4%
• saline
sodium chloride 0,9%

Locations

Country	Name	City	State
France	Medical Intensive Care Unit	Caen
France	Surgical Intensive Care Unit	Caen
France	Intensive care unit	Saint Lô

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	contrast induced acute kidney injury		72 hours	Yes