Clinical trial NCT00392405: Prevention of Contrast Induced Nephropathy With Sodium Bicarbonate
Official title: Prevention of Contrast Induced Nephropathy With Sodium Bicarbonate
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Contrast Induced Nephropathy
Keywords: Contrast Induced Nephropathy
Lead sponsor: Norton Community Hospital
Sponsor class: OTHER
First posted: 2006-10-26
Enrollment: 656
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This will be a randomized controlled trial closely following the original protocol in the previous study published in JAMA 2004 by Merten et al. Patients will be randomly assigned to one of two treatment groups. Treatment group A will receive 1cc/kg/hour of 0.9% normal saline at least 2 hours prior to study beginning and will be continued during and for 6 hours post contrast. Treatment group B will receive 3cc/kg of sodium bicarbonate solution for one hour prior to procedure then drip rate will be decreased to 1cc/kg/hour during and for 6 hours post procedure. The sodium bicarbonate solution will be made by adding 3 amps of bicarbonate to 1L of D5W. Patients in both treatment arms weighing \>110kg the initial fluid bolus and drip will be limited to those patients weighing 110kg. In both treatment arms, diuretics will be held before and after contrast administration on the day of the study. BMP will be checked the day of, 24 and 48 hours post contrast administration. The greatest change in all readings will be used for treatment comparisons. Contrast induced nephropathy will be defined as a change in serum creatinine of more than 25% from baseline and/or 0.5mg/dL. Urinary pH will also be measured on first spontaneous void following bolus. Vital signs including blood pressure and oxygen saturation will be documented every 4 hours to monitor patients closely for signs and symptoms of volume overload

Detailed description: Inclusion Criteria:

* Stage III Chronic Kidney Disease (GFR 30-60ml/min per 1.73m2 calculated by using MDRD equation)
* Inpatients at Norton Community Hospital scheduled to undergo diagnostic CT Scan using contrast between the hours of 7am and 6pm
* 18+ years of age

Exclusion Criteria

* Current clinical diagnosis of exacerbated congestive heart failure
* Creatinine \>8 mg/dL
* Change in serum Cre of at least 0.5mg/dL during previous 24hours
* Pre-existing dialysis patient
* Multiple myeloma
* Uncontrolled hypertension (definition: treated SBP \>160mmHg or DBP \>100mmHg
* Exposure to contrast 48 hours prior to study
* Allergy to contrast dye
* Pregnancy
* Patient has received pressor agents, fendolapam, mannitol, or mucomyst at time of study
* Acute myocardial infarction

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

Allocation Assignment: Patients who meet inclusion criteria and agree to participate in the study will pick a concealed number out of an open envelope. That number (between 1- 656) will correlate with a number on a sealed opaque envelope. Inside the opaque envelope will be a chart sticker. The chart sticker will have the words either normal saline or sodium bicarbonate. The envelope will not be opened until all patient information (ie. Patient ID sticker) is placed on the original chosen envelope. Then the chart sticker will be removed and placed on the chart

Protocol Outline:

This will be a randomized controlled trial closely following the original protocol in the previous study. Patients will be randomly assigned to one of two treatment groups. Treatment group A will receive 1cc/kg/hour of 0.9% normal saline at least 2 hours prior to study beginning and will be continued during and for 6 hours post contrast. Treatment group B will receive 3cc/kg of sodium bicarbonate solution for one hour prior to procedure then drip rate will be decreased to 1cc/kg/hour during and for 6 hours post procedure. The sodium bicarbonate solution will be made by adding 3 amps of bicarbonate to 1L of D5W. Patients in both treatment arms weighing \>110kg the initial fluid bolus and drip will be limited to those patients weighing 110kg. In both treatment arms, diuretics will be held before and after contrast administration on the day of the study. BMP will be checked the day of, 24 and 48 hours post contrast administration. The greatest change in all readings will be used for treatment comparisons. Contrast induced nephropathy will be defined as a change in serum creatinine of more than 25% from baseline and/or 0.5mg/dL. Urinary pH will also be measured on first spontaneous void following bolus. Vital signs including blood pressure and oxygen saturation will be documented every 4 hours to monitor patients closely for signs and symptoms of volume overload

Eligibility criteria: Inclusion Criteria:

* Stage III Chronic Kidney Disease (GFR 30-60ml/min per 1.73m2 calculated by using MDRD equation)
* Inpatients at Norton Community Hospital scheduled to undergo diagnostic CT Scan using contrast between the hours of 7am and 6pm
* 18+ years of age

Exclusion Criteria:

* Exclusion Criteria
* Current clinical diagnosis of exacerbated congestive heart failure
* Creatinine \>8 mg/dL
* Change in serum Cre of at least 0.5mg/dL during previous 24hours
* Pre-existing dialysis patient
* Multiple myeloma
* Uncontrolled hypertension (definition: treated SBP \>160mmHg or DBP \>100mmHg
* Exposure to contrast 48 hours prior to study
* Allergy to contrast dye
* Pregnancy
* Patient has received pressor agents, fendolapam, mannitol, or mucomyst at time of study
* Acute myocardial infarction

Primary outcomes:
measure: Development of contrast-induced nephropathy, defined as an increase in serum creatinine of 25% or more within 2 day after administration of contrast
Secondary outcomes:
measure: change in mean arterial pressure after initial bolus, mmHg
measure: urine pH after initial bolus
measure: contrast volume
measure: change in serum bicarbonate
measure: change in serum potassium
measure: change in serum glucose
measure: change in serum creatinine
measure: change in estimated glomerular filtration rate
measure: incidence of contrast induced nephropathy
Other outcomes:
Locations:
city: Norton
country: United States
facility: Norton Community Hospital
state: Virginia
Study officials:
affiliation: Norton Community Hospital
name: Donna S Sanders, DO
role: PRINCIPAL_INVESTIGATOR
affiliation: Norton Community Hospital
name: Mathew Cusano, MD
role: STUDY_DIRECTOR
References:
citation: Merten GJ, Burgess WP, Gray LV, Holleman JH, Roush TS, Kowalchuk GJ, Bersin RM, Van Moore A, Simonton CA 3rd, Rittase RA, Norton HJ, Kennedy TP. Prevention of contrast-induced nephropathy with sodium bicarbonate: a randomized controlled trial. JAMA. 2004 May 19;291(19):2328-34. doi: 10.1001/jama.291.19.2328.
citation: Barrett BJ, Parfrey PS. Clinical practice. Preventing nephropathy induced by contrast medium. N Engl J Med. 2006 Jan 26;354(4):379-86. doi: 10.1056/NEJMcp050801. No abstract available.