Prevention of Contrast Induced Nephropathy With Sodium Bicarbonate

Contrast Induced Nephropathy Clinical Trial

Official title:

Prevention of Contrast Induced Nephropathy With Sodium Bicarbonate

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00392405
• Other study ID #: A1
• Status: Not yet recruiting
• Phase: Phase 2
• First received: October 25, 2006
• Last updated: October 25, 2006
• Start date: November 2006

Study information

• Verified date: October 2006
• Source: Norton Community Hospital
• Contact: Donna S Sanders, DO
• Phone: 276-708-7021
• Email: dsanders_nch[@]yahoo.com
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 656
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Contrast Induced Nephropathy
• Kidney Diseases

Intervention

Drug:
• 3 amps of sodium bicarbonate mixed in one liter of D5W

Locations

Country	Name	City	State
United States	Norton Community Hospital	Norton	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Norton Community Hospital

Country where clinical trial is conducted

United States, 

References & Publications (2)

Barrett BJ, Parfrey PS. Clinical practice. Preventing nephropathy induced by contrast medium. N Engl J Med. 2006 Jan 26;354(4):379-86. Review. — View 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. — View Citation

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 2 day after administration of contrast
Secondary	change in mean arterial pressure after initial bolus, mmHg
Secondary	urine pH after initial bolus
Secondary	contrast volume
Secondary	change in serum bicarbonate
Secondary	change in serum potassium
Secondary	change in serum glucose
Secondary	change in serum creatinine
Secondary	change in estimated glomerular filtration rate
Secondary	incidence of contrast induced nephropathy