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Sodium Chloride and Contrast Nephropathy

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ClinicalTrials.gov Identifier: NCT03476460
Recruitment Status : Recruiting
First Posted : March 26, 2018
Last Update Posted : March 27, 2018
Sponsor:
Information provided by (Responsible Party):
Luis Manzano Espinosa, Hospital Universitario Ramon y Cajal

Brief Summary:

This phase II, open, non-inferiority, randomized and controlled clinical trial is aimed to ascertain the incidence of contrast nephropathy in outpatients undergoing CT scan with contrast.

Patients will be randomized to receive oral prophylaxis with capsules of sodium chloride and free water ingestion or prophylaxis with sodium chloride 0.9% intravenous solution.

The total dose (mmol) of sodium chloride will be the same regardless administration via. The contrast will be iodixanol.

Patients >65 years, of both sexes, with at least one of the following criteria: diabetes, stable heart failure or chronic kidney disease (estimated glomerular filtration rate between 30 and 60 ml/min), undergoing CT scan with contrast, and who give written informed consent, will be included in the study. Patients with estimated glomerular filtration rate <30 ml/min, serum potassium <3.5 mEq/L, infusion of iodine contrast in the previous 15 days, administration of nephrotoxic drugs in the previous 72 hours or expected in the following hours after contrast infusion, decompensated chronic conditions (heart failure, chronic obstructive pulmonary disease, hypertension), allergy to iodine contrast, or the presence of hyperchloremia or hypernatremia, will be excluded from the study.

Contrast nephropathy will be defined as the increase of serum creatinine >0.3 mg/dL from baseline, or the reduction of estimated glomerular filtration rate (MDRD-4) >25% from baseline, in the first 48 hours after contrast administration.


Condition or disease Intervention/treatment Phase
Kidney Failure, Chronic Kidney Failure, Acute Heart Failure Diabetes Drug: Oral sodium chloride Drug: Intravenous sodium chloride Phase 2

Detailed Description:

This phase II, open, non-inferiority, randomized and controlled clinical trial is aimed to ascertain the incidence of contrast nephropathy in outpatients undergoing CT scan with contrast.

Patients will be randomized to receive oral prophylaxis with capsules of sodium chloride and free water ingestion or prophylaxis with sodium chloride 0.9% intravenous solution.

In those patients randomly allocated to oral prophylaxis (n=133), patients will receive capsules of sodium chloride and free water ingestion (for each capsule of sodium chloride, patients will take 250 ml of water, assuring a minimum ingestion of 750 ml of water) in the 48 hours prior contrast injection. Patients will take capsules of sodium chloride at a dose of 100 mg/kg during 48 hours previous the injection of contrast (48, 40, 32, 24, 16, and 8 hours), at the moment of contrast injection and 12 hours after the injection of contrast. In those patients randomly allocated to receive sodium chloride 0.9% intravenous solution (n=133), patients will receive at hospital 3 ml/Kg of sodium chloride 0.9%, one hour previous contrast injection and 2 ml/kg during the 4 hours after contrast injection. The total dose (mmol) of sodium chloride will be the same regardless administration via. The contrast will be iodixanol (320 mg of iodine/ml, in 100 ml, at an infusion rate of 2-5 ml/sec).

Patients >65 years, of both sexes, with at least one of the following criteria: diabetes, stable heart failure or chronic kidney disease (estimated glomerular filtration rate between 30 and 60 ml/min), undergoing CT scan with contrast, and who give written informed consent, will be included in the study. Patients with estimated glomerular filtration rate <30 ml/min, serum potassium <3.5 mEq/L, infusion of iodine contrast in the previous 15 days, administration of nephrotoxic drugs in the previous 72 hours or expected in the following hours after contrast infusion, decompensated chronic conditions (heart failure, chronic obstructive pulmonary disease, hypertension), allergy to iodine contrast, or the presence of hyperchloremia or hypernatremia, will be excluded from the study.

Contrast nephropathy will be defined as the increase of serum creatinine >0.3 mg/dL from baseline, or the reduction of estimated glomerular filtration rate (MDRD-4) >25% from baseline, in the first 48 hours after contrast administration.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 266 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Efficacy of Oral Sodium Chloride vs iv Sodium Chloride in the Prevention of Contrast Nephropathy in Outpatients
Actual Study Start Date : March 1, 2014
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arm Intervention/treatment
Experimental: Oral sodium chloride
Patients will receive capsules of sodium chloride and free water ingestion (for each capsule of sodium chloride, patients will take 250 ml of water, assuring a minimum ingestion of 750 ml of water) in the 48 hours prior contrast injection. Patients will take capsules of sodium chloride at a dose of 100 mg/kg during 48 hours previous the injection of contrast (48, 40, 32, 24, 16, and 8 hours), at the moment of contrast injection and 12 hours after the injection of contrast.
Drug: Oral sodium chloride
Patients will receive capsules of sodium chloride and free water ingestion (for each capsule of sodium chloride, with 250 ml of water, assuring a minimum ingestion of 750 ml of water) in the 48 hours prior contrast injection. Patients will take capsules of sodium chloride at a dose of 100 mg/kg during 48 hours previous the injection of contrast (48, 40, 32, 24, 16, and 8 hours), at the moment of contrast injection and 12 hours after the injection of contrast.

Active Comparator: Intravenous sodium chloride
Patients will receive at hospital 3 ml/Kg of sodium chloride 0.9%, one hour previous contrast injection and 2 ml/kg during the 4 hours after contrast injection.
Drug: Intravenous sodium chloride
Patients will receive at hospital 3 ml/Kg of sodium chloride 0.9%, one hour previous contrast injection and 2 ml/kg during the 4 hours after contrast injection.




Primary Outcome Measures :
  1. Incidence of contrast nephropathy during the first 48 hours after contrast administration [ Time Frame: During the first 48 hours after contrast administration ]
    The incidence of contrast nephropathy, defined as the increase of serum creatinine >0.3 mg/dL from baseline, or the reduction of estimated glomerular filtration rate (MDRD-4) >25% from baseline.


Secondary Outcome Measures :
  1. Determination of biomarkers of contrast nephropathy during the first 48 hours after contrast administration [ Time Frame: During the first 48 hours after contrast administration ]
    To evaluate the clinical utility of different biomarkers for the early diagnosis of contrast nephropathy (cystatin C, MicroRNAs, NGAL, KIM-1, NAG, t-gelsolina, GM2AP, creatinine)



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients >65 years,
  • Both sexes,
  • With at least one of the following criteria: diabetes or stable heart failure or chronic kidney disease (estimated glomerular filtration rate between 30 and 60 ml/min),
  • Undergoing CT scan with contrast
  • Written informed consent.

Exclusion Criteria:

  • Estimated glomerular filtration rate <30 ml/min,
  • Serum potassium <3.5 mEq/L,
  • Infusion of iodine contrast in the previous 15 days,
  • Administration of nephrotoxic drugs in the previous 72 hours or expected in the following hours after contrast infusion,
  • Decompensated chronic conditions (heart failure, chronic obstructive pulmonary disease, hypertension),
  • Allergy to iodine contrast,
  • Presence of hyperchloremia or hypernatremia.

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): NCT03476460


Contacts
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Contact: Luis Manzano, MD, PhD 34913368921 luis.manzano@uah.es

Locations
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Spain
Hospital Universitario Ramon y Cajal Recruiting
Madrid, Spain, 28034
Contact: Luis Manzano, MD, PhD    34913368921    luis.manzano@uah.es   
Sponsors and Collaborators
Hospital Universitario Ramon y Cajal
Investigators
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Principal Investigator: Luis Manzano, MD, PhD Hospital Universitario Ramon y Cajal

Publications of Results:

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Responsible Party: Luis Manzano Espinosa, MD, PhD, Chief of Internal Medicine department, Hospital Universitario Ramon y Cajal
ClinicalTrials.gov Identifier: NCT03476460     History of Changes
Other Study ID Numbers: PNIC-Na
First Posted: March 26, 2018    Key Record Dates
Last Update Posted: March 27, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Luis Manzano Espinosa, Hospital Universitario Ramon y Cajal:
Acute kidney failure
CT scan
Iodine contrast
Sodium chloride
Additional relevant MeSH terms:
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Renal Insufficiency
Kidney Failure, Chronic
Acute Kidney Injury
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic