Contrast-induced NephropathyNCT00175227
Prevention of Contrast-Induced Nephropathy
A study testing intravenous saline hydration + mannitol + furosemide and intravenous saline hydration in people with Contrast-induced Nephropathy and Acute Renal Failure, run by University of Alberta at 1 site in Canada.
Trial summary
Patients with pre-existing kidney disease are at high risk of acute renal failure when exposed to radio-contrast dyes, for example during a cardiac angiogram. The investigators hypothesize that an infusion of saline + furosemide + mannitol will reduce rates of contrast-induced nephropathy when compared with saline… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Contrast-induced Nephropathy, Acute Renal Failure, Chronic Renal Failure
- What is being tested?
- intravenous saline hydration + mannitol + furosemide and intravenous saline hydration
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteCanada
- Study dates
- May 1996to Oct 2000
- Phase
- Interventional
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age > 21 years
- serum creatinine > 150 umol/L
- able and willing to provide informed consent
Who cannot join
- known hypersensitivity to contrast, furosemide, or mannitol
- unable to tolerate a fluid load (e.g., acute pulmonary edema)
- ESRD, on dialysis
- previous enrollment in this study or previous contrast administration with the last 2 weeks
- refusal by treating physician
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevention of Contrast-Induced Nephropathy: a Randomized Controlled Trial of Saline + Furosemide + Mannitol in High Risk Patients Undergoing Cardiac Angiography
Patients with pre-existing kidney disease are at high risk of acute renal failure when exposed to radio-contrast dyes, for example during a cardiac angiogram.
The investigators hypothesize that an infusion of saline + furosemide + mannitol will reduce rates of contrast-induced nephropathy when compared with saline infusion controls.
Read the detailed description
Patients with pre-existing kidney disease are at high risk of acute renal failure when exposed to radio-contrast dyes, for example during a cardiac angiogram.
We hypothesize that an infusion of saline + furosemide + mannitol will reduce rates of contrast-induced nephropathy when compared with saline infusion controls.
We define an episode of contrast nephropathy using the conventional often published definition of a 25% relative increase in serum creatinine OR a 44 umol absolute increase in serum creatinine within 48 hours of contrast exposure.
- Being tested
- intravenous saline hydration + mannitol + furosemide, intravenous saline hydration
- Keywords
- contrast-induced nephropathy, prevention, renal failure, cardiac angiogram
- Medical subject headings
- Acute Kidney Injury, Kidney Failure, Chronic, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intravenous saline hydration + mannitol + furosemideDrug
500 mls half-normal saline + 25g mannitol + 100 mg furosemide
intravenous saline hydrationDrug
500 mls half-normal saline
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Saline hydration + mannitol + furosemide Receives: Drug: intravenous saline hydration + mannitol + furosemide |
| Controls | Placebo comparator | Saline hydration without mannitol or furosemide Receives: Drug: intravenous saline hydration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients that develop contrast-induced nephropathy after cardiac angiography
Measured: Within 48 hours of angiogram
Secondary outcomes (4)
Safety of the intervention based on transfer to ICU, need for dialysis, or death
Measured: During hospitalization episode
Adverse clinical events and measures of renal function
Measured: 6 weeks post-angiogram
Health related quality of life
Measured: 6 weeks post-angiogram
Subgroup analyses based on (a) diabetes; (b) amount of contrast; and (c) baseline creatinine
Measured: Within 48 hours of angiogram
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startMay 1996
- Primary completionOct 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Contrast-induced NephropathyStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- Alberta Heritage Foundation for Medical Research
- Investigators
- Sumit R Majumdar, MD, MPH, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00175227
- Sponsor's protocol ID
- HSRIF #96-20
- Status last verified
- May 2011
- First submitted
- 10 Sep 2005
- Last updated
- 10 May 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Majumdar SR, Kjellstrand CM, Tymchak WJ, Hervas-Malo M, Taylor DA, Teo KK. Forced euvolemic diuresis with mannitol and furosemide for prevention of contrast-induced nephropathy in patients with CKD undergoing coronary angiography: a randomized controlled trial. Am J Kidney Dis. 2009 Oct;54(4):602-9. doi: 10.1053/j.ajkd.2009.03.024. Epub 2009 Jun 17.
PubMed 19535188Hashimoto H, Yamada H, Murata M, Watanabe N. Diuretics for preventing and treating acute kidney injury. Cochrane Database Syst Rev. 2025 Jan 29;1(1):CD014937. doi: 10.1002/14651858.CD014937.pub2.
PubMed 39878152
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Contrast-Induced Nephropathy: a Randomized Controlled Trial of Saline + Furosemide + Mannitol in High Risk Patients Undergoing Cardiac Angiography
- ClinicalTrials.gov ID
- NCT00175227
- Acronym / sponsor ID
- HSRIF #96-20
- Keywords
- contrast-induced nephropathy, prevention, renal failure, cardiac angiogram
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Collaborators
- Alberta Heritage Foundation for Medical Research
- Study start
- May 1996
- Primary completion
- Oct 2000 (actual)
- First posted
- 15 Sep 2005 (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.
Patients with pre-existing kidney disease are at high risk of acute renal failure when exposed to radio-contrast dyes, for example during a cardiac angiogram.
The investigators hypothesize that an infusion of saline + furosemide + mannitol will reduce rates of contrast-induced nephropathy when compared with saline infusion controls.
Detailed description
Patients with pre-existing kidney disease are at high risk of acute renal failure when exposed to radio-contrast dyes, for example during a cardiac angiogram.
We hypothesize that an infusion of saline + furosemide + mannitol will reduce rates of contrast-induced nephropathy when compared with saline infusion controls.
We define an episode of contrast nephropathy using the conventional often published definition of a 25% relative increase in serum creatinine OR a 44 umol absolute increase in serum creatinine within 48 hours of contrast exposure.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Drug: intravenous saline hydration + mannitol + furosemideSaline hydration + mannitol + furosemide |
| Controls | Placebo comparator | Drug: intravenous saline hydrationSaline hydration without mannitol or furosemide |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age > 21 years
- serum creatinine > 150 umol/L
- able and willing to provide informed consent
Key exclusion criteria (5 listed)
- known hypersensitivity to contrast, furosemide, or mannitol
- unable to tolerate a fluid load (e.g., acute pulmonary edema)
- ESRD, on dialysis
- previous enrollment in this study or previous contrast administration with the last 2 weeks
- refusal by treating physician
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intravenous saline hydration + mannitol + furosemide500 mls half-normal saline + 25g mannitol + 100 mg furosemide | Drug | Intervention |
| intravenous saline hydration500 mls half-normal saline | Drug | Controls |
Primary outcome
Proportion of patients that develop contrast-induced nephropathy after cardiac angiography
Time frame: Within 48 hours of angiogram
4 secondary outcomes
Safety of the intervention based on transfer to ICU, need for dialysis, or death
Time frame: During hospitalization episode
Adverse clinical events and measures of renal function
Time frame: 6 weeks post-angiogram
Health related quality of life
Time frame: 6 weeks post-angiogram
Subgroup analyses based on (a) diabetes; (b) amount of contrast; and (c) baseline creatinine
Time frame: Within 48 hours of angiogram
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2011.
- Results publication: PubMed 19535188Majumdar SR, Kjellstrand CM, Tymchak WJ, Hervas-Malo M, Taylor DA, Teo KK. Forced euvolemic diuresis with mannitol and furosemide for prevention of contrast-induced nephropathy in patients with CKD undergoing coronary angiography: a randomized controlled trial. Am J Kidney Dis. 2009 Oct;54(4):602-9. doi: 10.1053/j.ajkd.2009.03.024. Epub 2009 Jun 17.
- Derived from this study: PubMed 39878152Hashimoto H, Yamada H, Murata M, Watanabe N. Diuretics for preventing and treating acute kidney injury. Cochrane Database Syst Rev. 2025 Jan 29;1(1):CD014937. doi: 10.1002/14651858.CD014937.pub2.
Related trials for Contrast-induced Nephropathy
Recruiting
Effectiveness of Remote Ischemic Preconditioning for Prevention of Contrast Induced Acute Kidney Injury in Patients Undergoing Coronary Angiograms.
Contrast-induced Acute Kidney Injury (CI-AKI) Following Coronary Angiogram (CI-AKI), Contrast-induced Nephropathy Following Coronary Angiogram (CIN)
Not yet recruitingObservational study
Uric Acid to Albumin Ratio for Predicting Contrast Associated Acute Kidney Injury After Cardiac and Non Cardiac Procedures
Contrast-Induced Nephropathy, Acute Kidney Injury
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An Observational Study of Percutaneous Glomerular Filtration Rate (TGFR) in the Early Warning of Contrast-induced Acute Kidney Injury During the Peri-examination Period of Emergency Enhanced CT
Contrast-associated Acute Kidney Injury
Not yet recruitingObservational study
Beyond the Mehran Risk Score: Predictive Value of Total Ischemic Time for Contrast-Induced Nephropathy in ST Segment Elevation Myocardial Infarction Patients Undergoing Primary Percutaneous Coronary Intervention.
ST Elevation (STEMI) Myocardial Infarction, Contrast Induced Nephropathy (CIN)
Not yet recruitingObservational study
Contrast Volume as a Predictor of Kidney Injury Following Contrast-Enhanced CT
Contrast-Associated Acute Kidney Injury, Acute Kidney Injury
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.
Sumit R Majumdar, MD, MPH principal investigator
University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intravenous saline hydration + mannitol + furosemide and intravenous saline hydration in people with Contrast-induced Nephropathy and Acute Renal Failure, run by University of Alberta at 1 site in Canada.
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 5 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: finished, as of the sponsor's last update on 10 May 2011. 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 Canada. 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. Some participants in this study may receive a placebo. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Proportion of patients that develop contrast-induced nephropathy after cardiac angiography (time frame: Within 48 hours of angiogram). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00175227, which also lists 2 linked publications.
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 10 May 2011.