Back to resultsPreventing Contrast-induced Nephropathy: Evaluating Hydration Strategies and L-carnitine Administration (CinBiCarn)
Primary Purpose
Acute Kidney Injury, Renal Insufficiency
Status
Terminated
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Hydration strategy using saline
Hydration strategy using sodium bicarbonate
L-carnitine
Coronarography
Sponsored by
About this trial
This is an interventional prevention trial for Acute Kidney Injury focused on measuring contrast induced nephropathy, hydration strategy, L-carnitine
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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)
Sites / Locations
- CHU de Nîmes - Hôpital Universitaire Carémeau
- CHU d'Angers - Hôtel-Dieu
- CH d'Avignon - Centre Hospitalier Henri Duffaut
- CHU de Montpellier - Hôpital Lapeyronie
- CH de Perpignan - Hôpital Saint Jean
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Active Comparator
Experimental
Experimental
Arm Label
Bicarbonate
Saline
Bicar + L-Carnitine
Saline + L-carnitine
Arm Description
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
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
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
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
Outcomes
Primary Outcome Measures
Change in glomerular filtration rate
The change in MDRD glomerular filtration rate before coronarography, and 48 hours after the injection of contrast material.
Secondary Outcome Measures
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
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
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
Change in creatinemia
The brute change in creatinemia between baseline and Day 2
Change in creatinemia
The brute change in creatinemia between baseline and Day 3
Change in creatinemia
The brute change in creatinemia between baseline and Day 7
% Change in creatinemia
% change in creatinemia between baseline and Day 2
% Change in creatinemia
% change in creatinemia between baseline and Day 3
% Change in creatinemia
% change in creatinemia between baseline and Day 7
Change in glomerular filtration rate compared to baseline
Change in glomerular filtration (MDRD; ml/min/1.73m^2) rate compared to baseline
Change in glomerular filtration rate compared to baseline
Change in glomerular filtration (MDRD; ml/min/1.73m^2) rate compared to baseline
Change in glomerular filtration rate compared to baseline
Change in glomerular filtration (MDRD; ml/min/1.73m^2) rate compared to baseline
Quantity of contrast material injected / glomerular filtration rate
Quantity of iodine injected / glomerular filtration rate
Hemodialysis necessary?
Was hemodialysis required for the patient? yes/no
Mortality
The patient passed away during the study. yes/no
Change in serum ngal
The change in serum ngal (neutrophil gelatinase associated lipocalin) between baseline and 4 hours after the injection of contrast material.
Full Information
NCT ID
NCT01786824
First Posted
February 6, 2013
Last Updated
March 21, 2016
Sponsor
Centre Hospitalier Universitaire de Nīmes
1. Study Identification
Unique Protocol Identification Number
NCT01786824
Brief Title
Preventing Contrast-induced Nephropathy: Evaluating Hydration Strategies and L-carnitine Administration
Acronym
CinBiCarn
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Terminated
Why Stopped
Patient pathway has become infeasible due to pressure for shorter hospital stays. Not enough inclusions.
Study Start Date
December 2014 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nīmes
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Kidney Injury, Renal Insufficiency
Keywords
contrast induced nephropathy, hydration strategy, L-carnitine
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bicarbonate
Arm Type
Experimental
Arm Description
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
Arm Title
Saline
Arm Type
Active Comparator
Arm Description
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
Arm Title
Bicar + L-Carnitine
Arm Type
Experimental
Arm Description
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
Arm Title
Saline + L-carnitine
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Hydration strategy using saline
Other Intervention Name(s)
Sodium chloride hydration
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Hydration strategy using sodium bicarbonate
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
L-carnitine
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Coronarography
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in glomerular filtration rate
Description
The change in MDRD glomerular filtration rate before coronarography, and 48 hours after the injection of contrast material.
Time Frame
baseline versus 48 hours after contrast injection
Secondary Outcome Measure Information:
Title
Contrast induced nephropathy?
Description
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
Time Frame
Day 2
Title
Contrast induced nephropathy?
Description
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
Time Frame
Day 3
Title
Contrast induced nephropathy?
Description
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
Time Frame
Day 7
Title
Change in creatinemia
Description
The brute change in creatinemia between baseline and Day 2
Time Frame
baseline versus Day 2
Title
Change in creatinemia
Description
The brute change in creatinemia between baseline and Day 3
Time Frame
baseline versus Day 3
Title
Change in creatinemia
Description
The brute change in creatinemia between baseline and Day 7
Time Frame
baseline versus Day 7
Title
% Change in creatinemia
Description
% change in creatinemia between baseline and Day 2
Time Frame
baseline versus Day 2
Title
% Change in creatinemia
Description
% change in creatinemia between baseline and Day 3
Time Frame
baseline versus Day 3
Title
% Change in creatinemia
Description
% change in creatinemia between baseline and Day 7
Time Frame
baseline versus Day 7
Title
Change in glomerular filtration rate compared to baseline
Description
Change in glomerular filtration (MDRD; ml/min/1.73m^2) rate compared to baseline
Time Frame
baseline versus Day 2
Title
Change in glomerular filtration rate compared to baseline
Description
Change in glomerular filtration (MDRD; ml/min/1.73m^2) rate compared to baseline
Time Frame
baseline versus Day 3
Title
Change in glomerular filtration rate compared to baseline
Description
Change in glomerular filtration (MDRD; ml/min/1.73m^2) rate compared to baseline
Time Frame
baseline versus Day 7
Title
Quantity of contrast material injected / glomerular filtration rate
Time Frame
Day 0 - just after coronarography
Title
Quantity of iodine injected / glomerular filtration rate
Time Frame
Day 0, just after coronarography
Title
Hemodialysis necessary?
Description
Was hemodialysis required for the patient? yes/no
Time Frame
Day 7
Title
Mortality
Description
The patient passed away during the study. yes/no
Time Frame
Day 7
Title
Change in serum ngal
Description
The change in serum ngal (neutrophil gelatinase associated lipocalin) between baseline and 4 hours after the injection of contrast material.
Time Frame
baseline (just before coronarography) versus 4 hours after contrast injection
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pascal Reboul, MD
Organizational Affiliation
Centre Hospitalier Universitaire de Nîmes
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Nîmes - Hôpital Universitaire Carémeau
City
Nîmes Cedex 09
State/Province
Gard
ZIP/Postal Code
30029
Country
France
Facility Name
CHU d'Angers - Hôtel-Dieu
City
Angers
ZIP/Postal Code
49933
Country
France
Facility Name
CH d'Avignon - Centre Hospitalier Henri Duffaut
City
Avignon
ZIP/Postal Code
84902
Country
France
Facility Name
CHU de Montpellier - Hôpital Lapeyronie
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
CH de Perpignan - Hôpital Saint Jean
City
Perpignan
ZIP/Postal Code
66046
Country
France
12. IPD Sharing Statement
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Preventing Contrast-induced Nephropathy: Evaluating Hydration Strategies and L-carnitine Administration
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