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Oral Versus Intravenous Hydration to Prevent Contrast Induced Nephropathy (INOVATIO)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Radboud University
Sponsor:
Information provided by (Responsible Party):
Prof. Dr. J. Wetzels, Radboud University
ClinicalTrials.gov Identifier:
NCT01654328
First received: July 21, 2012
Last updated: November 22, 2013
Last verified: November 2013
  Purpose

The purpose of this study is to investigate if home-hydration is a non inferior alternative for in-hospital hydration in the prevention of Contrast Induced Nephropathy in high risk patients.


Condition Intervention
Radiographic Contrast Agent Nephropathy
Drug: Sodium chloride tablets
Drug: Isotonic saline intravenously

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Oral Versus Intravenous Hydration to Prevent Contrast Induced Nephropathy

Resource links provided by NLM:


Further study details as provided by Radboud University:

Primary Outcome Measures:
  • The primary endpoint will be change in the creatinine concentration between the 48-72 hours creatinine levels and the baseline levels, expressed as ratio. [ Time Frame: 48-72 hours after contrast administration ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • we will evaluate the incidence of contrast nephropathy in the groups defined as a rise in serum creatinine of ≥25% or ≥44umol/L 48-72 hours after contrast administration [ Time Frame: 48-72 hours after contrast administration ] [ Designated as safety issue: Yes ]
  • patient satisfaction. [ Time Frame: up to 1 week after intervention ] [ Designated as safety issue: No ]
    patient satisfacation will be evaluated using a questionnaire

  • the incidence of adverse events [ Time Frame: up to 1 week after intervention ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 2200
Study Start Date: August 2012
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm A: sodium chloride tablets
Arm A: sodium chloride 1g/10kg of body weight /day per os on day -2 and -1 before contrast exposure. With a maximum dose of 10 gram sodium chloride a day.
Drug: Sodium chloride tablets
sodium chloride 1g/10kg of body weight /day per os on day -2 and -1 before contrast exposure. With a maximum dose of 10 gram sodium chloride a day.
Active Comparator: B: isotonic saline intravenously
Sodium chloride solution (isotonic saline (NaCl 0.9%) total 1000ml in 4 hrs or (in case of heart failure or severe renal failure) 12 hrs before and in 4 or in 12 hrs after contrast administration.
Drug: Isotonic saline intravenously
isotonic saline (Nacl 0.9%) total 1000ml in 4 hrs or (in case of heart failure or severe renal failure) 12 hrs before and in 4 or in 12 hrs after contrast administration.

Detailed Description:

Rationale: Iodinated contrast media are regularly used in diagnostic and interventional procedures. The intravascular use of these contrast media can cause acute kidney injury (Contrast Induced Nephropathy). Contrast Induced Nephropathy is associated with increased morbidity and mortality. There are no treatment options, therefore preventive measures should be taken. Volume expansion reduces the risk of Contrast Induced Nephropathy. Current guidelines for the prevention of Contrast-Induced Nephropathy advise that high risk patients be admitted for hydration with intravenous normal saline for a period of 8-24 hours. This proposal evaluates an alternative method of hydration; home hydration with salt tablets.

Objective: To investigate if home-hydration is a non inferior alternative for in-hospital hydration in the prevention of Contrast Induced Nephropathy in high risk patients.

Study design: multi-centre randomized controlled trial.

Study population: Adult patients > 18 years undergoing an elective procedure involving intravascular administration of iodinated contrast media and at high risk for the development of Contrast Induced Nephropathy (as defined by guideline criteria).

Intervention: Arm A: sodium chloride 1g/10kg of body weight/day per os on day -2 and -1 before contrast exposure. With a maximum dose of 10 gram sodium chloride a day.

Arm B: Nacl 0.9% total 1000ml in 4 hrs or (in case of heart failure or severe renal failure) 12 hrs before and in 4 or in 12 hrs after contrast administration.

Main study parameters/endpoints: The incidence of Contrast Induced Nephropathy, effect on the need for hospitalisation, patient satisfaction.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Patients who are randomized for home hydration will receive salt tablets and start 48 hrs before the procedure. The risk of taking salt tablets is low, there are some reports of nausea. Because the investigators exclude patients who have decompensated heart failure the use of these amounts of salt is considered safe and the investigators do not expect signs of overhydration. The investigators monitor this by a telephone consult, 24 hours after the intake of the first tablets. Body weight and intake of tablets will be monitored. Before contrast administration a blood and urine sample will be taken.

Patients who are randomized for intravenous hydration will be admitted and will receive standard treatment for high risk patients with the addition of one blood and urine sample taken before contrast administration.

In all patients 48-72 hours after contrast administration a blood sample is taken to check for the development of CIN, this is standard treatment according to the guidelines.

The investigators will ask all patients to fill in a questionnaire on patient satisfaction.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients > 18 years undergoing an elective procedure involving intravascular administration of iodinated contrast media
  • high risk for the development of Contrast Induced Nephropathy (as defined by guideline criteria

Exclusion Criteria:

  • Age < 18.
  • Low risk for the development of CIN, therefore no need for hydration
  • Emergency contrast procedure.
  • Overt signs of overhydration; orthopnea or pulmonal rales at the time of the first consult.

Double or triple diuretic use for pre-existing heart failure. Severe heart failure, in which case salt load is not safe (physician decision) Severe renal failure (CKD stage V eGFR < 15ml/min/1.73m2) Multiple Myeloma. Repeated contrast exposure < 2 weeks Unstable serum creatinine > 25% change < 6 weeks The inability to provide written informed consent. Participation in another intervention study

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01654328

Contacts
Contact: J. Wetzels, MD 003124-3614761

Locations
Netherlands
Radboud University Nijmegen Medical Centre Recruiting
Nijmegen, Netherlands, 6500 HB
Principal Investigator: J. Wetzels, MD , PhD         
Sponsors and Collaborators
Prof. Dr. J. Wetzels
Investigators
Principal Investigator: Jack Wetzels, MD Radboud University
  More Information

No publications provided

Responsible Party: Prof. Dr. J. Wetzels, Clinical Professor, Radboud University
ClinicalTrials.gov Identifier: NCT01654328     History of Changes
Other Study ID Numbers: NL nr.: 40730.091.12
Study First Received: July 21, 2012
Last Updated: November 22, 2013
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Radboud University:
contrast media
kidney injury
hydration

Additional relevant MeSH terms:
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on November 25, 2014