Acute Renal FailureNCT00621972
AV Fistula Salvage in Advanced CKD Using Sodium Bicarbonate Prophylaxis
An observational study of Acute Renal Failure, run by MaineHealth at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Renal Failure
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to Nov 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Stage 4 and 5 chronic kidney disease patients with AV fistula placed but have not initiated dialysis.
Who may be able to join
- English speaking
- >18 yrs age
- chronic kidney disease, documented GFR<30ml/min by abbreviated MDRD calculation
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Maine Medical Center - Brighton Campus
Portland, Maine, 04101
About this study
Official title: A Prospective Observational Study on the Use of Iodinated Contrast for AV Fistula Salvage in Stage 4/5 CKD Using Bicarbonate Prophylaxis
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.
Read the 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.
- Conditions
- Acute Renal Failure
- Keywords
- acute renal failure, arteriovenous fistula, KIM-1, chronic kidney disease
- Medical subject headings
- Acute Kidney Injury, Arteriovenous Fistula, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Observation | Chronic kidney disease patients presenting for fisulta evaluation with documented GFR<30ml/min by abbreviated MDRD calculation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 48 hours
Secondary outcomes (2)
Assess the impact of conventional dose iodinated contrast on urinary kidney injury marker-1 (KIM-1) levels.
Measured: 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.
Measured: Baseline patient charcteristics.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2008 (estimated)
- Study startJan 2008
- Primary completionNov 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Renal FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- MaineHealth
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Scott M Benson, D.O., Principal investigator, Maine Medical Center - Division of Nephrology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00621972
- Sponsor's protocol ID
- MMC3230
- Other IDs
- 0200.178070
- Status last verified
- Sep 2018
- First submitted
- 12 Feb 2008
- Last updated
- 20 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Observational Study on the Use of Iodinated Contrast for AV Fistula Salvage in Stage 4/5 CKD Using Bicarbonate Prophylaxis
- ClinicalTrials.gov ID
- NCT00621972
- Acronym / sponsor ID
- MMC3230
- Conditions
- Acute Renal Failure
- Keywords
- acute renal failure, arteriovenous fistula, KIM-1, chronic kidney disease
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- MaineHealthUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 22 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observation | – | –Chronic kidney disease patients presenting for fisulta evaluation with documented GFR<30ml/min by abbreviated MDRD calculation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Stage 4 and 5 chronic kidney disease patients with AV fistula placed but have not initiated dialysis.
Key inclusion criteria (3 listed)
- English speaking
- >18 yrs age
- chronic kidney disease, documented GFR<30ml/min by abbreviated MDRD calculation
Key exclusion criteria (6 listed)
- Inpatients
- Pediatric patients
- Non-English speaking patients
- established dialysis patients
- patients receiving iodinated contrast within 30 days of current procedure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
2 secondary outcomes
Assess the impact of conventional dose iodinated contrast on urinary kidney injury marker-1 (KIM-1) levels.
Time frame: 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.
Time frame: Baseline patient charcteristics.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Scott M Benson, D.O. principal investigator
Maine Medical Center - Division of Nephrology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Renal Failure, run by MaineHealth at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 20 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2018.