Prevention of Contrast Induced Nephropathy With Sodium Bicarbonate

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2006 by Norton Community Hospital.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Norton Community Hospital
ClinicalTrials.gov Identifier:
NCT00392405
First received: October 25, 2006
Last updated: NA
Last verified: October 2006
History: No changes posted
  Purpose

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


Condition Intervention Phase
Contrast Induced Nephropathy
Drug: 3 amps of sodium bicarbonate mixed in one liter of D5W
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Norton Community Hospital:

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

Estimated Enrollment: 656
Study Start Date: November 2006
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  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: NCT00392405

Contacts
Contact: Donna S Sanders, DO 276-708-7021 dsanders_nch@yahoo.com

Locations
United States, Virginia
Norton Community Hospital
Norton, Virginia, United States, 24273
Sponsors and Collaborators
Norton Community Hospital
Investigators
Principal Investigator: Donna S Sanders, DO Norton Community Hospital
Study Director: Mathew Cusano, MD Norton Community Hospital
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00392405     History of Changes
Other Study ID Numbers: A1
Study First Received: October 25, 2006
Last Updated: October 25, 2006
Health Authority: United States: Institutional Review Board

Keywords provided by Norton Community Hospital:
Contrast Induced Nephropathy

Additional relevant MeSH terms:
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on July 05, 2015