Prevention of Contrast Induced Nephropathy With Sodium Bicarbonate

Acute Kidney Failure Clinical Trial

— PROMEC  

Official title:

Prevention of Contrast Induced Nephropathy With Sodium Bicarbonate

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00472563
• Other study ID #: 065-120606
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: May 10, 2007
• Last updated: May 5, 2008
• Start date: May 2007
• Est. completion date: February 2008

Study information

• Verified date: April 2008
• Source: Universidad de Antioquia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
• Study type: Interventional

Clinical Trial Summary

Deterioration of kidney renal function occurs in a minority of people due to contrast-required procedures. The purpose of this study is to compare two different interventions to reduce the risk of kidney injury after contrast medium exposition.

We will perform a randomized clinical trial following a modification of a previously published protocol (Merten et al.JAMA 2004;291(19):2328-34). Patients will be randomly assigned to one of two groups of treatment. Group A will receive 1 cc/kg/hour of 0.9% saline infusion starting 12 hours before and continuing 12 hours after the procedure. Group B will receive 3 cc/kg of sodium bicarbonate solution for one hour prior to procedure, then drip rate will be decreased to 1 cc/kg/hour until 6 hours post procedure.

Description:

We will perform a randomized clinical trial following a modification of a previously published protocol (Merten et al.JAMA 2004;291(19):2328-34). Patients will be randomly assigned to one of two groups of treatment. Group A will receive 1 cc/kg/hour of 0.9% saline infusion starting 12 hours before and continuing 12 hours after the procedure. Group B will receive 3 cc/kg of sodium bicarbonate solution for one hour prior to procedure, then drip rate will be decreased to 1 cc/kg/hour until 6 hours post procedure.

Phase 2/3 study Study Type: Interventional Study Design: Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study.

Subjects: Consecutive samples of all inpatients who meet the inclusion criteria

Primary outcomes: Development of contrast induced nephropathy, defined as an increase in serum creatinine of 25% or more within 48 h after administration of contrast.

Secondary outcomes: change in serum bicarbonate; change in serum potassium; change in serum creatinine.

Expected total enrollment: 212

Allocation Assignment: Patients who meet inclusion criteria and agree to participate in the study will be assigned by a random number table to saline or bicarbonate, using closed envelopes and stratifying according to history of diabetes and type of procedure (cardiac catheterism or others).

Condition: Contrast Induced Nephropathy

Intervention: 75 cc of sodium bicarbonate (8.4%) mixed in 425 cc of D5W

Gender: both Age: 18+ years of age Recruitment Status: participants are currently being recruited

Facility location:

Universidad de Antioquia, Internal Medicine Department; Hospital Universitario San Vicente de Paul. Medellin, Colombia.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 212
• Est. completion date: February 2008
• Est. primary completion date: February 2008
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18+ years of age

• Inpatient at Hospital Universitario San Vicente de Paúl scheduled to undergo diagnostic CT scan using contrast or angiography and either

• Serum creatinine 1.2 mg/dl or more, or

• Type 2 Diabetes Mellitus

Exclusion Criteria:

• Current clinical diagnosis of exacerbated congestive heart failure

• Exposure to contrast 30 days prior to study

• Allergy to contrast dye

• Chronic renal disease with dialysis therapy

• Acute renal failure with dialytic urgency

• Urgency procedure needed

• Systolic blood pressure < 90 or vasopressor support

• No authorization by patient or physician in charge

• Serum potassium < 3 mEq/L

• Ejection fraction < 35% by previous echocardiography

• Acute pulmonary edema in previous 48 hours

Study Design

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

Related Conditions & MeSH terms

• Acute Kidney Failure
• Acute Kidney Injury
• Kidney Diseases
• Renal Insufficiency

Intervention

Drug:
• Bicarbinate 150 mEq/L
75 cc of sodium bicarbonate (8.4%) mixed in 425 cc of D5W

Locations

Country	Name	City	State
Colombia	Hospital Universitario San Vicente Paúl	Medellín	Antioquia

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Antioquia

Country where clinical trial is conducted

Colombia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	development of contrast induced nephropathy, defined as an increase in serum creatinine of 25% or more within 48 h after administration of contrast		48 h
Secondary	change in serum bicarbonate; change in serum potassium; change in serum creatinine		48 h