Prevention of Contrast Induced Nephropathy With Sodium Bicarbonate (PROMEC)

This study has been completed.
Sponsor:
Information provided by:
Universidad de Antioquia
ClinicalTrials.gov Identifier:
NCT00472563
First received: May 10, 2007
Last updated: May 5, 2008
Last verified: April 2008
  Purpose

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.


Condition Intervention Phase
Acute Kidney Failure
Drug: Bicarbinate 150 mEq/L
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Prevention
Official Title: Prevention of Contrast Induced Nephropathy With Sodium Bicarbonate

Resource links provided by NLM:


Further study details as provided by Universidad de Antioquia:

Primary Outcome Measures:
  • development of contrast induced nephropathy, defined as an increase in serum creatinine of 25% or more within 48 h after administration of contrast [ Time Frame: 48 h ]

Secondary Outcome Measures:
  • change in serum bicarbonate; change in serum potassium; change in serum creatinine [ Time Frame: 48 h ]

Enrollment: 212
Study Start Date: May 2007
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Bicarbinate 150 mEq/L
    75 cc of sodium bicarbonate (8.4%) mixed in 425 cc of D5W
Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00472563

Locations
Colombia
Hospital Universitario San Vicente Paúl
Medellín, Antioquia, Colombia, 57
Sponsors and Collaborators
Universidad de Antioquia
Investigators
Principal Investigator: Wilmar A Maya Salazar, MD Universidad de Antioquia
Study Chair: 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 Director: Fabian A Jaimes, MD Universidad de Antioquia
Study Chair: Alvaro García, MD Universidad de Antioquia
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00472563     History of Changes
Other Study ID Numbers: 065-120606
Study First Received: May 10, 2007
Last Updated: May 5, 2008
Health Authority: Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos

Keywords provided by Universidad de Antioquia:
bicarbonate
nephropathy
contrast

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency
Acute Kidney Injury
Urologic Diseases

ClinicalTrials.gov processed this record on September 22, 2014