Radiographic Contrast Agent NephropathyINOVATIONCT01654328
Oral Versus Intravenous Hydration to Prevent Contrast Induced Nephropathy
A study testing Sodium chloride tablets and Isotonic saline intravenously in people with Radiographic Contrast Agent Nephropathy, run by Prof. Dr. J. Wetzels at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Radiographic Contrast Agent Nephropathy
- What is being tested?
- Sodium chloride tablets and Isotonic saline intravenously
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 256 participants
- Where
- 1 siteNetherlands
- Study dates
- Aug 2012to Oct 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Radboud University Nijmegen Medical Centre
Nijmegen, 6500 HB
About this study
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.
Read the 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.
- Conditions
- Radiographic Contrast Agent Nephropathy
- Being tested
- Sodium chloride tablets, Isotonic saline intravenously
- Keywords
- contrast media, kidney injury, hydration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium chloride tabletsDrug
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.
Isotonic saline intravenouslyDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Isotonic saline intravenously |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint will be change in the creatinine concentration between the 48-72 hours creatinine levels and the baseline levels, expressed as ratio.
Measured: 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
Measured: 48-72 hours after contrast administration
patient satisfaction.
patient satisfacation will be evaluated using a questionnaire
Measured: up to 1 week after intervention
the incidence of adverse events
Measured: up to 1 week after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2012 (estimated)
- Study startAug 2012
- Primary completionOct 2014
- Study completionOct 2014
Why it stopped: slow inclusion
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiographic Contrast Agent NephropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 256 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prof. Dr. J. Wetzels
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Prof. Dr. J. Wetzels, Radboud University Medical Center
- Investigators
- Jack Wetzels, MD, Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01654328
- Sponsor's protocol ID
- NL nr.: 40730.091.12
- Acronym
- INOVATIO
- Status last verified
- Mar 2015
- First submitted
- 21 Jul 2012
- Last updated
- 1 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Versus Intravenous Hydration to Prevent Contrast Induced Nephropathy
- ClinicalTrials.gov ID
- NCT01654328
- Acronym / sponsor ID
- INOVATIO / NL nr.: 40730.091.12
- Conditions
- Radiographic Contrast Agent Nephropathy
- Keywords
- contrast media, kidney injury, hydration
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: slow inclusion
- Enrolment
- 256 participants (actual)
- Lead sponsor
- Prof. Dr. J. WetzelsUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 31 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A: sodium chloride tablets | Experimental | Drug: Sodium chloride tabletsArm 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. |
| B: isotonic saline intravenously | Active comparator | Drug: Isotonic saline intravenouslySodium 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sodium chloride tabletssodium 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 | Arm A: sodium chloride tablets |
| Isotonic saline intravenouslyisotonic 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 | B: isotonic saline intravenously |
Primary outcome
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
3 secondary outcomes
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
patient satisfaction.
Time frame: up to 1 week after intervention
the incidence of adverse events
Time frame: up to 1 week after intervention
Results and safety
The study was stopped early (reason given: slow inclusion). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2015.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jack Wetzels, MD principal investigator
Radboud University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sodium chloride tablets and Isotonic saline intravenously in people with Radiographic Contrast Agent Nephropathy, run by Prof. Dr. J. Wetzels at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: slow inclusion). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2015.