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Preventing Contrast-induced Nephropathy: Evaluating Hydration Strategies and L-carnitine Administration (CinBiCarn)

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ClinicalTrials.gov Identifier: NCT01786824
Recruitment Status : Terminated (Patient pathway has become infeasible due to pressure for shorter hospital stays. Not enough inclusions.)
First Posted : February 8, 2013
Last Update Posted : March 22, 2016
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes

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.

Condition or disease Intervention/treatment Phase
Acute Kidney Injury Renal Insufficiency Drug: Hydration strategy using saline Drug: Hydration strategy using sodium bicarbonate Drug: L-carnitine Procedure: Coronarography Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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 Start Date : December 2014
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arm Intervention/treatment
Experimental: Bicarbonate

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

Drug: Hydration strategy using sodium bicarbonate
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.

Procedure: Coronarography
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.

Active Comparator: Saline

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

Drug: Hydration strategy using saline
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.
Other Name: Sodium chloride hydration

Procedure: Coronarography
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.

Experimental: Bicar + L-Carnitine

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

Drug: Hydration strategy using sodium bicarbonate
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.

Drug: L-carnitine

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.


Procedure: Coronarography
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.

Experimental: Saline + L-carnitine

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

Drug: Hydration strategy using saline
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.
Other Name: Sodium chloride hydration

Drug: L-carnitine

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.


Procedure: Coronarography
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 Measures :
  1. 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.


Secondary Outcome Measures :
  1. Contrast induced nephropathy? [ Time Frame: Day 2 ]

    The presence/absence of contrast induced nephropathy, defined by the presence of at least one of the following:

    1. a >= 25% increase in creatinemia as compared to baseline
    2. an absolute increase >= 44 µmol/L in creatinemia as compared to baseline
    3. a decrease >= 25% in glomerular filtration rate as compared to baseline

  2. Contrast induced nephropathy? [ Time Frame: Day 3 ]

    The presence/absence of contrast induced nephropathy, defined by the presence of at least one of the following:

    1. a >= 25% increase in creatinemia as compared to baseline
    2. an absolute increase >= 44 µmol/L in creatinemia as compared to baseline
    3. a decrease >= 25% in glomerular filtration rate as compared to baseline

  3. Contrast induced nephropathy? [ Time Frame: Day 7 ]

    The presence/absence of contrast induced nephropathy, defined by the presence of at least one of the following:

    1. a >= 25% increase in creatinemia as compared to baseline
    2. an absolute increase >= 44 µmol/L in creatinemia as compared to baseline
    3. a decrease >= 25% in glomerular filtration rate as compared to baseline

  4. Change in creatinemia [ Time Frame: baseline versus Day 2 ]
    The brute change in creatinemia between baseline and Day 2

  5. Change in creatinemia [ Time Frame: baseline versus Day 3 ]
    The brute change in creatinemia between baseline and Day 3

  6. Change in creatinemia [ Time Frame: baseline versus Day 7 ]
    The brute change in creatinemia between baseline and Day 7

  7. % Change in creatinemia [ Time Frame: baseline versus Day 2 ]
    % change in creatinemia between baseline and Day 2

  8. % Change in creatinemia [ Time Frame: baseline versus Day 3 ]
    % change in creatinemia between baseline and Day 3

  9. % Change in creatinemia [ Time Frame: baseline versus Day 7 ]
    % change in creatinemia between baseline and Day 7

  10. Change in glomerular filtration rate compared to baseline [ Time Frame: baseline versus Day 2 ]
    Change in glomerular filtration (MDRD; ml/min/1.73m^2) rate compared to baseline

  11. Change in glomerular filtration rate compared to baseline [ Time Frame: baseline versus Day 3 ]
    Change in glomerular filtration (MDRD; ml/min/1.73m^2) rate compared to baseline

  12. Change in glomerular filtration rate compared to baseline [ Time Frame: baseline versus Day 7 ]
    Change in glomerular filtration (MDRD; ml/min/1.73m^2) rate compared to baseline

  13. Quantity of contrast material injected / glomerular filtration rate [ Time Frame: Day 0 - just after coronarography ]
  14. Quantity of iodine injected / glomerular filtration rate [ Time Frame: Day 0, just after coronarography ]
  15. Hemodialysis necessary? [ Time Frame: Day 7 ]
    Was hemodialysis required for the patient? yes/no

  16. Mortality [ Time Frame: Day 7 ]
    The patient passed away during the study. yes/no

  17. Change in serum ngal [ Time Frame: baseline (just before coronarography) versus 4 hours after contrast injection ]
    The change in serum ngal (neutrophil gelatinase associated lipocalin) between baseline and 4 hours after the injection of contrast material.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01786824


Locations
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France
CHU de Nîmes - Hôpital Universitaire Carémeau
Nîmes Cedex 09, Gard, France, 30029
CHU d'Angers - Hôtel-Dieu
Angers, France, 49933
CH d'Avignon - Centre Hospitalier Henri Duffaut
Avignon, France, 84902
CHU de Montpellier - Hôpital Lapeyronie
Montpellier, France, 34295
CH de Perpignan - Hôpital Saint Jean
Perpignan, France, 66046
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Investigators
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Principal Investigator: Pascal Reboul, MD Centre Hospitalier Universitaire de Nîmes

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Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT01786824     History of Changes
Other Study ID Numbers: LOCAL/2012/PR-03
2012-004134-42 ( EudraCT Number )
First Posted: February 8, 2013    Key Record Dates
Last Update Posted: March 22, 2016
Last Verified: March 2016
Keywords provided by Centre Hospitalier Universitaire de Nīmes:
contrast induced nephropathy
hydration strategy
L-carnitine
Additional relevant MeSH terms:
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Kidney Diseases
Acute Kidney Injury
Renal Insufficiency
Urologic Diseases
Pharmaceutical Solutions