Oral Versus Intravenous Hydration to Prevent Contrast Induced Nephropathy

NCT01654328 | Terminated DMC

• 1 other identifier: NL nr.: 40730.091.12
• Study Type: interventional
• Target: 256
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Radiographic Contrast Agent Nephropathy

Keywords

contrast media; kidney injury; hydration

Outcome Measures

Primary Outcomes (1)

• The primary endpoint will be change in the creatinine concentration between the 48-72 hours creatinine levels and the baseline levels, expressed as ratio.

  48-72 hours after contrast administration

Secondary Outcomes (3)

• 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

  48-72 hours after contrast administration

• patient satisfaction.

  up to 1 week after intervention

• the incidence of adverse events

  up to 1 week after intervention

Study Arms (2)

Arm A: sodium chloride tablets

EXPERIMENTAL

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

B: isotonic saline intravenously

ACTIVE COMPARATOR

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

Interventions

Sodium chloride tablets DRUG

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 A: sodium chloride tablets

Isotonic saline intravenously DRUG

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.

B: isotonic saline intravenously

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Prof. Dr. J. Wetzels: lead

Study Sites (1)

Radboud University Nijmegen Medical Centre

Nijmegen, 6500 HB, Netherlands

Location

MeSH Terms

Interventions

Sodium Chloride

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Jack Wetzels, MD

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: July 21, 2012
• First Posted: July 31, 2012
• Study Start: August 1, 2012
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: April 1, 2015

Record last verified: 2015-03

Locations

NL (1)