AV Fistula Salvage in Advanced CKD Using Sodium Bicarbonate Prophylaxis

NCT00621972 | Withdrawn

• 2 other identifiers: MMC32300200.178070
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Renal Failure

Keywords

acute renal failure; arteriovenous fistula; KIM-1; chronic kidney disease

Outcome Measures

Primary Outcomes (1)

• 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.

  48 hours

Secondary Outcomes (2)

• Assess the impact of conventional dose iodinated contrast on urinary kidney injury marker-1 (KIM-1) levels.

  3 hours and 48 hours

• 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.

  Baseline patient charcteristics.

Study Arms (1)

Observation

Chronic kidney disease patients presenting for fisulta evaluation with documented GFR\<30ml/min by abbreviated MDRD calculation.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• MaineHealth: lead

Study Sites (1)

Maine Medical Center - Brighton Campus

Portland, Maine, 04101, United States

Location

MeSH Terms

Conditions

Acute Kidney Injury; Arteriovenous Fistula; Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Arteriovenous Malformations; Vascular Malformations; Cardiovascular Abnormalities; Cardiovascular Diseases; Vascular Fistula; Vascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Chronic Disease; Disease Attributes; Pathologic Processes

Study Officials

• Scott M Benson, D.O.

  Maine Medical Center - Division of Nephrology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2008
• First Posted: February 22, 2008
• Study Start: January 1, 2008
• Primary Completion: November 1, 2009
• Study Completion: November 1, 2009
• Last Updated: September 20, 2018

Record last verified: 2018-09

Locations

US (1)