Clinical trial NCT00472563: Prevention of Contrast Induced Nephropathy With Sodium Bicarbonate
Official title: Prevention of Contrast Induced Nephropathy With Sodium Bicarbonate
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Acute Kidney Failure
Keywords: bicarbonate
nephropathy
contrast
Lead sponsor: Universidad de Antioquia
Sponsor class: OTHER
First posted: 2007-05-11
Enrollment: 212
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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 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

Primary outcomes:
measure: development of contrast induced nephropathy, defined as an increase in serum creatinine of 25% or more within 48 h after administration of contrast
timeFrame: 48 h
Secondary outcomes:
measure: change in serum bicarbonate; change in serum potassium; change in serum creatinine
timeFrame: 48 h
Other outcomes:
Locations:
city: Medellín
country: Colombia
facility: Hospital Universitario San Vicente Paúl
state: Antioquia
Study officials:
affiliation: Universidad de Antioquia
name: Wilmar A Maya Salazar, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidad de Antioquia
name: Julián M Aristizábal, MD
role: STUDY_CHAIR
affiliation: Universidad de Antioquia
name: Oscar M Santos, MD
role: STUDY_CHAIR
affiliation: Universidad de Antioquia
name: John F Nieto, MD
role: STUDY_CHAIR
affiliation: Universidad de Antioquia
name: Liliana Jaramillo, MD
role: STUDY_CHAIR
affiliation: Universidad de Antioquia
name: Jorge I García, MD
role: STUDY_CHAIR
affiliation: Universidad de Antioquia
name: Fabian A Jaimes, MD
role: STUDY_DIRECTOR
affiliation: Universidad de Antioquia
name: Alvaro García, MD
role: STUDY_CHAIR
References: