Acute Kidney InjuryPhase 3CinBiCarnNCT01786824
Preventing Contrast-induced Nephropathy: Evaluating Hydration Strategies and L-carnitine Administration
A Phase 3 study testing Hydration strategy using saline, Hydration strategy using sodium bicarbonate and L-carnitine in people with Acute Kidney Injury and Renal Insufficiency, run by Centre Hospitalier Universitaire de Nīmes at 5 sites in France.
Trial summary
The general objective of this open, pilot study is to characterize biological parameters related to acute kidney injury among patients undergoing a programmed coronarography with injection of contrast material. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury, Renal Insufficiency
- What is being tested?
- Hydration strategy using saline, Hydration strategy using sodium bicarbonate and L-carnitine
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 5 sitesFrance
- Study dates
- Dec 2014to Aug 2015
- Phase
- Phase 3
- 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
- The patient must have given his/her informed and signed consent
- The patient must be insured or beneficiary of a health insurance plan
- The patient is scheduled for a coronarography
- The patient can come back to the hospital on days 2 and 7 after the coronarography for follow up
- The patient has moderate to severe renal insufficiency (glomerular filtration rate < 60 ml / min / 1.73 m^2)
- The patient has not had any oral antidiabetic treatments, or diuretic treatments, within 48 hours preceding the coronarography
- Lack of treatment with ACE inhibitors or ARA2 24 hours prior to coronary
Who cannot join
- The patient is participating in another study
- The patient is in an exclusion period determined by another study
- The patient is under judicial protection
- The patient is under any kind of guardianship
- The patient refuses to sign the consent form
- It is impossible to correctly inform the patient
Show all 15Show fewer
- The patient is unable to participate in follow-up visits at days 2 and 7 after the coronarography
- The patient is pregnant or breastfeeding
- The patient is taking L-carnitine
- The patient has a contra indication for a treatment used in this study
- Acute heart failure
- Infarction, acute phase
- Hemodialysis patient
- Myeloma
- Epileptic patient treated with Depakine (valproic acid) (carnitine can lower epilepsy-related thresholds by speeding up the metabolism of Depakine)
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
CHU d'Angers - Hôtel-Dieu
Angers, 49933
CH d'Avignon - Centre Hospitalier Henri Duffaut
Avignon, 84902
CHU de Montpellier - Hôpital Lapeyronie
Montpellier, 34295
CHU de Nîmes - Hôpital Universitaire Carémeau
Nîmes, Gard, 30029
CH de Perpignan - Hôpital Saint Jean
Perpignan, 66046
About this study
Official title: Preventing Nephropathy Induced by Iodinated Contrast Media in Patients With Renal Impairment: a Randomized Trial Evaluating the Effectiveness of Two Hydration Strategies and L-carnitine Administration
The general objective of this open, pilot study is to characterize biological parameters related to acute kidney injury among patients undergoing a programmed coronarography with injection of contrast material. The study focuses on two main factors that may influence acute kidney injury: (1) sodium chloride hydration strategy versus sodium bicarbonate hydration strategy and (2) presence of oral L-carnitine treatment versus absence of oral L-carnitine treatment. We will also test for a potential interaction between these two factors.
- Conditions
- Acute Kidney Injury, Renal Insufficiency
- Being tested
- Hydration strategy using saline, Hydration strategy using sodium bicarbonate, L-carnitine, Coronarography
- Keywords
- contrast induced nephropathy, hydration strategy, L-carnitine
- Medical subject headings
- Acute Kidney Injury, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydration strategy using salineDrug
Also called Sodium chloride hydration
For 12 hours preceding the coronarography, and for 12 following the coronarography, 0.9% sodium chloride at 1 ml/kg/h is administered via a slow intravenous perfusion.
Hydration strategy using sodium bicarbonateDrug
For 4-6 hours before the coronarography and for 4-6 hours after the coronarography, 500 ml of isotonic sodium bicarbonate solution (1.4%) will be administered via a slow intravenous solution.
L-carnitineDrug
Before the coronarography (D-1), 1 gram of L-carnitine is administered via an oral solution that can be diluted in a small amount of sugar water if necessary. This administration corresponds to the beginning of a hydration protocol.
For days 0 to 7 after the coronarography, patients are administered an oral L-carnitine solution (3 grams of L-carnitine per day). The latter may be diluted in a small amount of sugar water if needed.
CoronarographyProcedure or surgery
All patients included in this study are programmed for a coronarography with injection of contrast material (either iodixanol or ioxaglate). The day of coronarography = Day 0.
| Study group | Role | What they receive |
|---|---|---|
| Bicarbonate | Experimental | The patients included in this arm will be administered a hydration regime for the prevention of contrast-induced nephropathy containing sodium bicarbonate.
Intervention: Hydration strategy using sodium bicarbonate Intervention: Coronarography Receives: Drug: Hydration strategy using sodium bicarbonate; Procedure: Coronarography |
| Saline | Active comparator | The patients included in this arm will be administered a hydration regime for the prevention of contrast-induced nephropathy using sodium chloride solution.
Intervention: Hydration strategy using saline Intervention: Coronarography Receives: Drug: Hydration strategy using saline; Procedure: Coronarography |
| Bicar + L-Carnitine | Experimental | The patients included in this arm will be administered a hydration regime for the prevention of contrast-induced nephropathy containing sodium bicarbonate. They will also receive an oral L-carnitine solution on days -1, 0, 1 to 7.
Intervention: Hydration strategy using sodium bicarbonate Intervention: L-carnitine Intervention: Coronarography Receives: Drug: Hydration strategy using sodium bicarbonate; Drug: L-carnitine; Procedure: Coronarography |
| Saline + L-carnitine | Experimental | The patients included in this arm will be administered a hydration regime for the prevention of contrast-induced nephropathy using sodium chloride solution. They will also receive an oral L-carnitine solution on days -1, 0, 1 to 7.
Intervention: Hydration strategy using saline Intervention: L-carnitine Intervention: Coronarography Receives: Drug: Hydration strategy using saline; Drug: L-carnitine; Procedure: Coronarography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in glomerular filtration rate
The change in MDRD glomerular filtration rate before coronarography, and 48 hours after the injection of contrast material.
Measured: baseline versus 48 hours after contrast injection
Secondary outcomes (17)
Contrast induced nephropathy?
The presence/absence of contrast induced nephropathy, defined by the presence of at least one of the following:
- a >= 25% increase in creatinemia as compared to baseline
- an absolute increase >= 44 µmol/L in creatinemia as compared to baseline
- a decrease >= 25% in glomerular filtration rate as compared to baseline
Measured: Day 2
Contrast induced nephropathy?
The presence/absence of contrast induced nephropathy, defined by the presence of at least one of the following:
- a >= 25% increase in creatinemia as compared to baseline
- an absolute increase >= 44 µmol/L in creatinemia as compared to baseline
- a decrease >= 25% in glomerular filtration rate as compared to baseline
Measured: Day 3
Contrast induced nephropathy?
The presence/absence of contrast induced nephropathy, defined by the presence of at least one of the following:
- a >= 25% increase in creatinemia as compared to baseline
- an absolute increase >= 44 µmol/L in creatinemia as compared to baseline
- a decrease >= 25% in glomerular filtration rate as compared to baseline
Measured: Day 7
Change in creatinemia
The brute change in creatinemia between baseline and Day 2
Measured: baseline versus Day 2
Change in creatinemia
The brute change in creatinemia between baseline and Day 3
Measured: baseline versus Day 3
Change in creatinemia
The brute change in creatinemia between baseline and Day 7
Measured: baseline versus Day 7
% Change in creatinemia
% change in creatinemia between baseline and Day 2
Measured: baseline versus Day 2
% Change in creatinemia
% change in creatinemia between baseline and Day 3
Measured: baseline versus Day 3
% Change in creatinemia
% change in creatinemia between baseline and Day 7
Measured: baseline versus Day 7
Change in glomerular filtration rate compared to baseline
Change in glomerular filtration (MDRD; ml/min/1.73m^2) rate compared to baseline
Measured: baseline versus Day 2
Change in glomerular filtration rate compared to baseline
Change in glomerular filtration (MDRD; ml/min/1.73m^2) rate compared to baseline
Measured: baseline versus Day 3
Change in glomerular filtration rate compared to baseline
Change in glomerular filtration (MDRD; ml/min/1.73m^2) rate compared to baseline
Measured: baseline versus Day 7
Quantity of contrast material injected / glomerular filtration rate
Measured: Day 0 - just after coronarography
Quantity of iodine injected / glomerular filtration rate
Measured: Day 0, just after coronarography
Hemodialysis necessary?
Was hemodialysis required for the patient? yes/no
Measured: Day 7
Mortality
The patient passed away during the study. yes/no
Measured: Day 7
Change in serum ngal
The change in serum ngal (neutrophil gelatinase associated lipocalin) between baseline and 4 hours after the injection of contrast material.
Measured: baseline (just before coronarography) versus 4 hours after contrast injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2013 (estimated)
- Study startDec 2014
- Primary completionAug 2015
- Study completionAug 2015
Why it stopped: Patient pathway has become infeasible due to pressure for shorter hospital stays. Not enough inclusions.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pascal Reboul, MD, Principal investigator, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01786824
- Sponsor's protocol ID
- LOCAL/2012/PR-03
- Other IDs
- 2012-004134-42
- Acronym
- CinBiCarn
- Status last verified
- Mar 2016
- First submitted
- 6 Feb 2013
- Last updated
- 22 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Nephropathy Induced by Iodinated Contrast Media in Patients With Renal Impairment: a Randomized Trial Evaluating the Effectiveness of Two Hydration Strategies and L-carnitine Administration
- ClinicalTrials.gov ID
- NCT01786824
- Acronym / sponsor ID
- CinBiCarn / LOCAL/2012/PR-03
- Conditions
- Acute Kidney Injury, Renal Insufficiency
- Keywords
- contrast induced nephropathy, hydration strategy, L-carnitine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Patient pathway has become infeasible due to pressure for shorter hospital stays. Not enough inclusions.
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 8 Feb 2013 (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 general objective of this open, pilot study is to characterize biological parameters related to acute kidney injury among patients undergoing a programmed coronarography with injection of contrast material. The study focuses on two main factors that may influence acute kidney injury: (1) sodium chloride hydration strategy versus sodium bicarbonate hydration strategy and (2) presence of oral L-carnitine treatment versus absence of oral L-carnitine treatment. We will also test for a potential interaction between these two factors.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Bicarbonate | Experimental | Drug: Hydration strategy using sodium bicarbonate, Procedure: CoronarographyThe patients included in this arm will be administered a hydration regime for the prevention of contrast-induced nephropathy containing sodium bicarbonate. Intervention: Hydration strategy using sodium bicarbonate Intervention: Coronarography |
| Saline | Active comparator | Drug: Hydration strategy using saline, Procedure: CoronarographyThe patients included in this arm will be administered a hydration regime for the prevention of contrast-induced nephropathy using sodium chloride solution. Intervention: Hydration strategy using saline Intervention: Coronarography |
| Bicar + L-Carnitine | Experimental | Drug: Hydration strategy using sodium bicarbonate, Drug: L-carnitine, Procedure: CoronarographyThe patients included in this arm will be administered a hydration regime for the prevention of contrast-induced nephropathy containing sodium bicarbonate. They will also receive an oral L-carnitine solution on days -1, 0, 1 to 7. Intervention: Hydration strategy using sodium bicarbonate Intervention: L-carnitine Intervention: Coronarography |
| Saline + L-carnitine | Experimental | Drug: Hydration strategy using saline, Drug: L-carnitine, Procedure: CoronarographyThe patients included in this arm will be administered a hydration regime for the prevention of contrast-induced nephropathy using sodium chloride solution. They will also receive an oral L-carnitine solution on days -1, 0, 1 to 7. Intervention: Hydration strategy using saline Intervention: L-carnitine Intervention: Coronarography |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- The patient must have given his/her informed and signed consent
- The patient must be insured or beneficiary of a health insurance plan
- The patient is scheduled for a coronarography
- The patient can come back to the hospital on days 2 and 7 after the coronarography for follow up
- The patient has moderate to severe renal insufficiency (glomerular filtration rate < 60 ml / min / 1.73 m^2)
Key exclusion criteria (15 listed)
- The patient is participating in another study
- The patient is in an exclusion period determined by another study
- The patient is under judicial protection
- The patient is under any kind of guardianship
- The patient refuses to sign the consent form
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 |
|---|---|---|
| Hydration strategy using salineAlso: Sodium chloride hydrationFor 12 hours preceding the coronarography, and for 12 following the coronarography, 0.9% sodium chloride at 1 ml/kg/h is administered via a slow intravenous perfusion. | Drug | Saline, Saline + L-carnitine |
| Hydration strategy using sodium bicarbonateFor 4-6 hours before the coronarography and for 4-6 hours after the coronarography, 500 ml of isotonic sodium bicarbonate solution (1.4%) will be administered via a slow intravenous solution. | Drug | Bicar + L-Carnitine, Bicarbonate |
| L-carnitineBefore the coronarography (D-1), 1 gram of L-carnitine is administered via an oral solution that can be diluted in a small amount of sugar water if necessary. This administration corresponds to the beginning of a hydration protocol. For days 0 to 7 after the coronarography, patients are administered an oral L-carnitine solution (3 grams of L-carnitine per day). The latter may be diluted in a small amount of sugar water if needed. | Drug | Bicar + L-Carnitine, Saline + L-carnitine |
| CoronarographyAll patients included in this study are programmed for a coronarography with injection of contrast material (either iodixanol or ioxaglate). The day of coronarography = Day 0. | Procedure or surgery | Bicar + L-Carnitine, Bicarbonate, Saline, Saline + L-carnitine |
Primary outcome
Change in glomerular filtration rate
Time frame: baseline versus 48 hours after contrast injection
The change in MDRD glomerular filtration rate before coronarography, and 48 hours after the injection of contrast material.
17 secondary outcomes
Contrast induced nephropathy?
Time frame: Day 2
Contrast induced nephropathy?
Time frame: Day 3
Contrast induced nephropathy?
Time frame: Day 7
Change in creatinemia
Time frame: baseline versus Day 2
Change in creatinemia
Time frame: baseline versus Day 3
Change in creatinemia
Time frame: baseline versus Day 7
% Change in creatinemia
Time frame: baseline versus Day 2
% Change in creatinemia
Time frame: baseline versus Day 3
% Change in creatinemia
Time frame: baseline versus Day 7
Change in glomerular filtration rate compared to baseline
Time frame: baseline versus Day 2
Change in glomerular filtration rate compared to baseline
Time frame: baseline versus Day 3
Change in glomerular filtration rate compared to baseline
Time frame: baseline versus Day 7
Quantity of contrast material injected / glomerular filtration rate
Time frame: Day 0 - just after coronarography
Quantity of iodine injected / glomerular filtration rate
Time frame: Day 0, just after coronarography
Hemodialysis necessary?
Time frame: Day 7
Mortality
Time frame: Day 7
Change in serum ngal
Time frame: baseline (just before coronarography) versus 4 hours after contrast injection
Results and safety
The study was stopped early (reason given: Patient pathway has become infeasible due to pressure for shorter hospital stays. Not enough inclusions.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2016.
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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.
Pascal Reboul, MD principal investigator
Centre Hospitalier Universitaire de Nīmes
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Hydration strategy using saline, Hydration strategy using sodium bicarbonate and L-carnitine in people with Acute Kidney Injury and Renal Insufficiency, run by Centre Hospitalier Universitaire de Nīmes at 5 sites in France.
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 7 inclusion and 15 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: stopped early, as of the sponsor's last update on 22 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Patient pathway has become infeasible due to pressure for shorter hospital stays. Not enough inclusions.). Results are not available in the source record.
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?
Change in glomerular filtration rate (time frame: baseline versus 48 hours after contrast injection). 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 22 Mar 2016.