Radiographic Contrast Agent NephropathyPhase 4NEPHRONNCT00584350
Prevention of Contrast Nephropathy During Diagnostic Coronary Angiogram or PCI With Hydratation Based on LEVDP
A Phase 4 study testing Hydratation according LVEDP + NaHCO3, normal saline and Sodium bicarbonate in people with Radiographic Contrast Agent Nephropathy and Renal Failure, run by Université de Sherbrooke at 1 site in Canada.
Trial summary
The goal is to determine if prehydration based on LEVDP is superior to a standard hydratation with NaCl 0.9% or NaHCO3 for the prevention of contrast nephropathy related to a diagnostic coronary angiogram or to PCI. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Radiographic Contrast Agent Nephropathy, Renal Failure, Coronary Heart Disease
- What is being tested?
- Hydratation according LVEDP + NaHCO3, normal saline and Sodium bicarbonate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 330 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2007to Dec 2015
- Phase
- Phase 4
- 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
Who may be able to join
- minimum 18 years old
- chronic renal insufficiency with a calculated creatinine clearance below 60 cc /min. (estimated with the MDRD formula)
- hemodynamically stable
Who cannot join
- Acute renal failure or in recuperation of acute renal failure
- urgent coronary angiogram
- moderate to severe valvulopathy or presence of a valvular prosthesis
- diagnostic of multiple myeloma
- dialysis before test
- having had a test with contrast product in the 2 weeks preceding
- receiving a nephrotoxic in the last month.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
CHUS, clinical research center
Sherbrooke, Quebec, J1H 5N4
Michel Nguyen, MD, FRCPC
About this study
The goal is to determine if prehydration based on LEVDP is superior to a standard hydratation with NaCl 0.9% or NaHCO3 for the prevention of contrast nephropathy related to a diagnostic coronary angiogram or to PCI.
Read the detailed description
The goal is to determine if prehydration based on LEVDP is superior to a standard hydratation, independant of volemic status, with NaCl 0.9% or NaHCO3 for the prevention of contrast nephropathy related to a diagnostic coronary angiogram or to PCI.
- Being tested
- Hydratation according LVEDP + NaHCO3, normal saline, Sodium bicarbonate
- Keywords
- coronary angiogram, percutaneous coronary intervention
- Medical subject headings
- Renal Insufficiency, Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydratation according LVEDP + NaHCO3Other
Hydration with bolus of NaCl 0.9 to reach a LVEDP of 18 mmHg or more. This procedure is done while the patient is in the laboratory, with a catheter in the left ventricle.
At the same time, an infusion of a sodium bicarbonate solution (150 mEq/L) is started at a rate of 1 ml/kg/h (max 110 ml/h) for 7 hours.
normal salineOther
hydratation with normal saline (1 cc/kg/h; max 110 cc/h) starting at 8PM the day before the test and ending at 8PM the day of the test (24 hours total).
Sodium bicarbonateOther
hydratation with sodium bicarbonate (150 mEq/L) at 3 cc/kg/h (max 330 cc/h) for 1 hour before the test and then, to be continued at 1 cc/kg/h (max 110 cc/h) for 6 hours (total of 7 hours of hydratation).
| Study group | Role | What they receive |
|---|---|---|
| A: Hydratation according LVEDP + NaHCO3 | Experimental | Hydration with bolus of NaCl 0.9 to reach a LVEDP of 18 mmHg or more. This procedure is done while the patient is in the laboratory, with a catheter in the left ventricle.
At the same time, an infusion of a sodium bicarbonate solution (150 mEq/L) is started at a rate of 1 ml/kg/h (max 110 ml/h) for 7 hours. Receives: Other: Hydratation according LVEDP + NaHCO3 |
| B: Standard hydratation | Active comparator | hydratation with normal saline (1 cc/kg/h; max 110 cc/h) starting at 8PM the day before the test and ending at 8PM the day of the test (24 hours total). Receives: Other: normal saline |
| C: Hydratation with sodium bicarbonate | Experimental | hydratation with sodium bicarbonate (150 mEq/L) at 3 cc/kg/h (max 330 cc/h) for 1 hour before the test and then, to be continued at 1 cc/kg/h (max 110 cc/h) for 6 hours (total of 7 hours of hydratation). Receives: Other: Sodium bicarbonate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of contrast nephropathy described as an increase of 44 micromol/L in plasma creatinine 48 hours after the injection of contrast product.
Measured: 48 hours
Secondary outcomes (3)
changes in glomerular filtration in the 3 groups (measured with MDRD formula)
Measured: 48 hours
clinical events during the procedure or after (ex. pulmonary edema)
Measured: during hospitalisation
Incidence of contrast nephropathy defined as an increase of 25% of the creatinine value at 48 hours
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2008 (estimated)
- Study startNov 2007
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiographic Contrast Agent NephropathyStudies of the same condition, open and under way.
- More trials run by Université de SherbrookeThe 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 330 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université de Sherbrooke
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michel Nguyen, Université de Sherbrooke
- Investigators
- Michel Nguyen, MD, FRCPC, Principal investigator, Sherbrooke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00584350
- Sponsor's protocol ID
- 03-70-M5
- Acronym
- NEPHRON
- Status last verified
- Feb 2015
- First submitted
- 20 Dec 2007
- Last updated
- 12 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Contrast Nephropathy During Diagnostic Coronary Angiogram or PCI With Hydratation Based on LEVDP
- ClinicalTrials.gov ID
- NCT00584350
- Acronym / sponsor ID
- NEPHRON / 03-70-M5
- Keywords
- coronary angiogram, percutaneous coronary intervention
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 330 participants (estimated)
- Lead sponsor
- Université de SherbrookeUniversity, hospital or other
- Study start
- Nov 2007
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 2 Jan 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.
The goal is to determine if prehydration based on LEVDP is superior to a standard hydratation with NaCl 0.9% or NaHCO3 for the prevention of contrast nephropathy related to a diagnostic coronary angiogram or to PCI.
Detailed description
The goal is to determine if prehydration based on LEVDP is superior to a standard hydratation, independant of volemic status, with NaCl 0.9% or NaHCO3 for the prevention of contrast nephropathy related to a diagnostic coronary angiogram or to PCI.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A: Hydratation according LVEDP + NaHCO3 | Experimental | Other: Hydratation according LVEDP + NaHCO3Hydration with bolus of NaCl 0.9 to reach a LVEDP of 18 mmHg or more. This procedure is done while the patient is in the laboratory, with a catheter in the left ventricle. At the same time, an infusion of a sodium bicarbonate solution (150 mEq/L) is started at a rate of 1 ml/kg/h (max 110 ml/h) for 7 hours. |
| B: Standard hydratation | Active comparator | Other: normal salinehydratation with normal saline (1 cc/kg/h; max 110 cc/h) starting at 8PM the day before the test and ending at 8PM the day of the test (24 hours total). |
| C: Hydratation with sodium bicarbonate | Experimental | Other: Sodium bicarbonatehydratation with sodium bicarbonate (150 mEq/L) at 3 cc/kg/h (max 330 cc/h) for 1 hour before the test and then, to be continued at 1 cc/kg/h (max 110 cc/h) for 6 hours (total of 7 hours of hydratation). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- minimum 18 years old
- chronic renal insufficiency with a calculated creatinine clearance below 60 cc /min. (estimated with the MDRD formula)
- hemodynamically stable
Key exclusion criteria (7 listed)
- Acute renal failure or in recuperation of acute renal failure
- urgent coronary angiogram
- moderate to severe valvulopathy or presence of a valvular prosthesis
- diagnostic of multiple myeloma
- dialysis before test
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 |
|---|---|---|
| Hydratation according LVEDP + NaHCO3Hydration with bolus of NaCl 0.9 to reach a LVEDP of 18 mmHg or more. This procedure is done while the patient is in the laboratory, with a catheter in the left ventricle. At the same time, an infusion of a sodium bicarbonate solution (150 mEq/L) is started at a rate of 1 ml/kg/h (max 110 ml/h) for 7 hours. | Other | A: Hydratation according LVEDP + NaHCO3 |
| normal salinehydratation with normal saline (1 cc/kg/h; max 110 cc/h) starting at 8PM the day before the test and ending at 8PM the day of the test (24 hours total). | Other | B: Standard hydratation |
| Sodium bicarbonatehydratation with sodium bicarbonate (150 mEq/L) at 3 cc/kg/h (max 330 cc/h) for 1 hour before the test and then, to be continued at 1 cc/kg/h (max 110 cc/h) for 6 hours (total of 7 hours of hydratation). | Other | C: Hydratation with sodium bicarbonate |
Primary outcome
Incidence of contrast nephropathy described as an increase of 44 micromol/L in plasma creatinine 48 hours after the injection of contrast product.
Time frame: 48 hours
3 secondary outcomes
changes in glomerular filtration in the 3 groups (measured with MDRD formula)
Time frame: 48 hours
clinical events during the procedure or after (ex. pulmonary edema)
Time frame: during hospitalisation
Incidence of contrast nephropathy defined as an increase of 25% of the creatinine value at 48 hours
Time frame: 48 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2015.
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.
Michel Nguyen, MD, FRCPC principal investigator
Sherbrooke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Hydratation according LVEDP + NaHCO3, normal saline and Sodium bicarbonate in people with Radiographic Contrast Agent Nephropathy and Renal Failure, run by Université de Sherbrooke 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 7 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: status not confirmed, as of the sponsor's last update on 12 Feb 2015. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michel Nguyen, MD, FRCPC (819 346-1110 ext. 15251, michel.nguyen@usherbrooke.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of contrast nephropathy described as an increase of 44 micromol/L in plasma creatinine 48 hours after the injection of contrast product. (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 12 Feb 2015.