Prevention of Contrast Induced Nephropathy With Sodium Bicarbonate

NCT00472563 | Completed Phase 2 DMC

• 1 other identifier: 065-120606
• Study Type: interventional
• Target: 212
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Kidney Failure

Keywords

bicarbonate; nephropathy; contrast

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• change in serum bicarbonate; change in serum potassium; change in serum creatinine

  48 h

Interventions

Bicarbinate 150 mEq/L DRUG

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• + 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidad de Antioquia: lead

Study Sites (1)

Hospital Universitario San Vicente Paúl

Medellín, Antioquia, 57, Colombia

Location

MeSH Terms

Conditions

Acute Kidney Injury; Kidney Diseases

Condition Hierarchy (Ancestors)

Renal Insufficiency; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Wilmar A Maya Salazar, MD

  Universidad de Antioquia

  PRINCIPAL INVESTIGATOR

• Julián M Aristizábal, MD

  Universidad de Antioquia

  STUDY CHAIR

• Oscar M Santos, MD

  Universidad de Antioquia

  STUDY CHAIR

• John F Nieto, MD

  Universidad de Antioquia

  STUDY CHAIR

• Liliana Jaramillo, MD

  Universidad de Antioquia

  STUDY CHAIR

• Jorge I García, MD

  Universidad de Antioquia

  STUDY CHAIR

• Fabian A Jaimes, MD

  Universidad de Antioquia

  STUDY DIRECTOR

• Alvaro García, MD

  Universidad de Antioquia

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 10, 2007
• First Posted: May 11, 2007
• Study Start: May 1, 2007
• Primary Completion: February 1, 2008
• Study Completion: February 1, 2008
• Last Updated: May 6, 2008

Record last verified: 2008-04

Locations

CO (1)