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Prevention of Contrast Induced Nephropathy With Sodium Bicarbonate

Primary Purpose

Contrast Induced Nephropathy

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
3 amps of sodium bicarbonate mixed in one liter of D5W
Sponsored by
Norton Community Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Contrast Induced Nephropathy focused on measuring Contrast Induced Nephropathy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Norton Community Hospital

Outcomes

Primary Outcome Measures

Development of contrast-induced nephropathy, defined as an increase in serum creatinine of 25% or more within 2 day after administration of contrast

Secondary Outcome Measures

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

Full Information

First Posted
October 25, 2006
Last Updated
October 25, 2006
Sponsor
Norton Community Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00392405
Brief Title
Prevention of Contrast Induced Nephropathy With Sodium Bicarbonate
Official Title
Prevention of Contrast Induced Nephropathy With Sodium Bicarbonate
Study Type
Interventional

2. Study Status

Record Verification Date
October 2006
Overall Recruitment Status
Unknown status
Study Start Date
November 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Norton Community Hospital

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Contrast Induced Nephropathy
Keywords
Contrast Induced Nephropathy

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
656 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
3 amps of sodium bicarbonate mixed in one liter of D5W
Primary Outcome Measure Information:
Title
Development of contrast-induced nephropathy, defined as an increase in serum creatinine of 25% or more within 2 day after administration of contrast
Secondary Outcome Measure Information:
Title
change in mean arterial pressure after initial bolus, mmHg
Title
urine pH after initial bolus
Title
contrast volume
Title
change in serum bicarbonate
Title
change in serum potassium
Title
change in serum glucose
Title
change in serum creatinine
Title
change in estimated glomerular filtration rate
Title
incidence of contrast induced nephropathy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Donna S Sanders, DO
Phone
276-708-7021
Email
dsanders_nch@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Donna S Sanders, DO
Organizational Affiliation
Norton Community Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mathew Cusano, MD
Organizational Affiliation
Norton Community Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Norton Community Hospital
City
Norton
State/Province
Virginia
ZIP/Postal Code
24273
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
15150204
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.
Results Reference
background
PubMed Identifier
16436769
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.
Results Reference
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Prevention of Contrast Induced Nephropathy With Sodium Bicarbonate

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