AV Fistula Salvage in Advanced CKD Using Sodium Bicarbonate Prophylaxis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2008 by Maine Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Maine Medical Center
ClinicalTrials.gov Identifier:
NCT00621972
First received: February 12, 2008
Last updated: February 21, 2008
Last verified: January 2008
  Purpose

This is an observational study assessing the impact of conventional dose iodinated contrast on the renal function of advanced chronic kidney disease patients undergoing arteriovenous fistula evaluation using a standard sodium bicarbonate prophylaxis protocol. In addition, this model allows for pre and post procedure measurements of kidney function, providing a unique opportunity to assess the utility of novel biomarkers for contrast-induced kidney injury.

Our primary hypothesis is that there will be no change in serum creatinine post-procedure when using a standard sodium bicarbonate prophylaxis protocol. Our secondary hypothesis is that there will be no change in urinary kidney-injury marker-1 (KIM-1) post-procedure using a standard sodium bicarbonate prophylaxis protocol. In addition, we will assess the impact of different patient characteristics on the development of contrast-induced kidney injury, such as diabetes, coronary artery disease, hypertension, and angiotensin converting enzyme inhibitor therapy.


Condition
Acute Renal Failure

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Observational Study on the Use of Iodinated Contrast for AV Fistula Salvage in Stage 4/5 CKD Using Bicarbonate Prophylaxis

Resource links provided by NLM:


Further study details as provided by Maine Medical Center:

Primary Outcome Measures:
  • Assess the impact of conventional dose iodinated contrast on the renal function of stage 4 and 5 chronic kidney disease patients undergoing arteriovenous fistula evaluation using a standard sodium bicarbonate prophylaxis protocol. [ Time Frame: 48 hours ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Assess the impact of conventional dose iodinated contrast on urinary kidney injury marker-1 (KIM-1) levels. [ Time Frame: 3 hours and 48 hours ] [ Designated as safety issue: Yes ]
  • Assess the impact of different patient characteristics on the development of contrast-induced kidney injury, such as diabetes, coronary artery disease, hypertension, and angiotensin converting enzyme inhibitor therapy. [ Time Frame: Baseline patient charcteristics. ] [ Designated as safety issue: No ]

Estimated Enrollment: 25
Study Start Date: January 2008
Estimated Study Completion Date: January 2009
Estimated Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
Observation
Chronic kidney disease patients presenting for fisulta evaluation with documented GFR<30ml/min by abbreviated MDRD calculation.

Detailed Description:

The National Kidney Foundation publishes kidney disease outcome guidelines for improving care of the chronic kidney disease (CKD) patient. Regarding hemodialysis vascular access, the recommendation is for early placement of an arteriovenous fistula (AVF) to improve morbidity and mortality outcomes, specifically when the glomerular filtration rate is less than 25ml/min, corresponding to stage 4 and 5 CKD. Despite its advantages, the need for surveillance of the AVF to determine maturation for use and maintain optimal longevity requires the use of interventional procedures. While radiocontrast use can lead to acute, often reversible kidney injury, its use in AVF evaluation has renewed interest with the recent implication of gadolinium-enhanced MRI being associated with a rare disorder of skin swelling and induration called nephrogenic systemic fibrosis. CKD patients are particularly susceptible to long term adverse outcomes from contrast-induced kidney injury, with 1 year mortality in stage 4 and 5 CKD patients being 44% and 62%, respectively. While optimal fluid therapy to prevent contrast-induced kidney injury remains uncertain, several prospective randomized trials using sodium bicarbonate pretreatment have shown a lower incidence of contrast-related kidney injury compared to isotonic saline. Traditional markers of acute kidney injury, including serum creatinine, blood urea nitrogen, and creatinine clearance have been insensitive in differentiating contrast-induced kidney injury from other forms of renal injury. Kidney injury marker-1 (KIM-1) is a transmembrane receptor induced to very high levels in the proximal tubule of the nephron following ischemic and nephrotoxic injury. KIM-1 has been shown in a small cohort of patients to differentiate ischemic kidney injury from other forms of acute and chronic kidney disease.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Stage 4 and 5 chronic kidney disease patients with AV fistula placed but have not initiated dialysis.

Criteria

Inclusion Criteria:

  • English speaking
  • >18 yrs age
  • chronic kidney disease, documented GFR<30ml/min by abbreviated MDRD calculation

Exclusion Criteria:

  • Inpatients
  • Pediatric patients
  • Non-English speaking patients
  • established dialysis patients
  • patients receiving iodinated contrast within 30 days of current procedure
  • patients with central arterial manipulation within 30 days of current procedure
  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: NCT00621972

Contacts
Contact: Scott M Benson, D.O. 207-662-2417 bensos@mmc.org
Contact: Brad Schimelman, M.D. 207-662-2417 schimb@mmc.org

Locations
United States, Maine
Maine Medical Center - Brighton Campus Recruiting
Portland, Maine, United States, 04101
Contact: Scott M Benson, D.O.    207-662-2417    bensos@mmc.org   
Contact: Brad Schimelman, M.D.    207-662-2417    schimb@mmc.org   
Sub-Investigator: Brad Schimelman, M.D.         
Sub-Investigator: Mark G Parker, M.D.         
Sub-Investigator: Robert Zimmerman, M.D.         
Sponsors and Collaborators
Maine Medical Center
Investigators
Principal Investigator: Scott M Benson, D.O. Maine Medical Center - Division of Nephrology
  More Information

No publications provided

Responsible Party: Scott Benson, DO, Maine Medical Center
ClinicalTrials.gov Identifier: NCT00621972     History of Changes
Other Study ID Numbers: MMC3230, 0200.178070
Study First Received: February 12, 2008
Last Updated: February 21, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Maine Medical Center:
acute renal failure
arteriovenous fistula
KIM-1
chronic kidney disease

Additional relevant MeSH terms:
Acute Kidney Injury
Fistula
Renal Insufficiency
Kidney Diseases
Pathological Conditions, Anatomical
Urologic Diseases

ClinicalTrials.gov processed this record on October 21, 2014