Radiographic Contrast Agent NephropathyPhase 3REPRECINNCT02029820
RenalGuard System for Prevention of Contrast Induced Nephropathy
A Phase 3 study testing RenalGuard in people with Radiographic Contrast Agent Nephropathy, run by Hospital Sao Lucas da PUCRS at 1 site in Brazil.
Trial summary
The purpose of this study is to determine whether hydration with intravenous saline matched with urine output, using the device RenalGuard is superior to standard hydration with saline to prevent contrast-induced nephropathy. 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?
- RenalGuard
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2012to Dec 2015
- Phase
- Phase 3
- 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
- serum creatinine >1.2mg/dl
- glomerular filtration rate (GFR) < 60ml/min
Who cannot join
- acute renal failure
- use of radiological contrast in the latest 7 days
- Current use of N-acetylcysteine or hydration of sodium bicarbonate
- Patients in dialysis
- Emergency procedures
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Hospital São Lucas -PUCRS, Serviço de Hemodinâmica
Porto Alegre, Rio Grande do Sul, 90610-000
Aryadina Piva, RN, 55 51 3320 3494, pesquisa@cardiarte.com.br
Vitor O Gomes, MD, PhD
About this study
Official title: RenalGuard System for Prevention of Contrast Induced Nephropathy - A Randomized Trial
The purpose of this study is to determine whether hydration with intravenous saline matched with urine output, using the device RenalGuard is superior to standard hydration with saline to prevent contrast-induced nephropathy.
- Conditions
- Radiographic Contrast Agent Nephropathy
- Being tested
- RenalGuard
- Keywords
- Contrast Nephropathy, Prevention, Renalguard
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RenalGuardDevice
Intravenous saline hydration matched with urine output, using the device Renalguard
| Study group | Role | What they receive |
|---|---|---|
| RenalGuard | Active comparator | Hydration with the device renalguard Receives: Device: RenalGuard |
| Saline | No intervention | Hydration with saline 1ml/Kg/h for 12h |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of contrast-induced nephropathy
Contrast-induced nephropathy defined as an increase of serum creatinine of 0.5mg/dl or 25% in pre procedure serum creatinine at 72h after procedure
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2014 (estimated)
- Study startAug 2012
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Sao Lucas da PUCRS
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vitor Osorio Gomes, Hospital Sao Lucas da PUCRS
- Investigators
- Vitor O Gomes, MD,PhD, Principal investigator, Hospital Sao Lucas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02029820
- Sponsor's protocol ID
- 11/05339
- Acronym
- REPRECIN
- Status last verified
- Jan 2014
- First submitted
- 6 Jan 2014
- Last updated
- 8 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RenalGuard System for Prevention of Contrast Induced Nephropathy - A Randomized Trial
- ClinicalTrials.gov ID
- NCT02029820
- Acronym / sponsor ID
- REPRECIN / 11/05339
- Conditions
- Radiographic Contrast Agent Nephropathy
- Keywords
- Contrast Nephropathy, Prevention, Renalguard
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Hospital Sao Lucas da PUCRSUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 8 Jan 2014 (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 determine whether hydration with intravenous saline matched with urine output, using the device RenalGuard is superior to standard hydration with saline to prevent contrast-induced nephropathy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RenalGuard | Active comparator | Device: RenalGuardHydration with the device renalguard |
| Saline | No intervention | –Hydration with saline 1ml/Kg/h for 12h |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- serum creatinine >1.2mg/dl
- glomerular filtration rate (GFR) < 60ml/min
Key exclusion criteria (5 listed)
- acute renal failure
- use of radiological contrast in the latest 7 days
- Current use of N-acetylcysteine or hydration of sodium bicarbonate
- Patients in dialysis
- Emergency procedures
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 |
|---|---|---|
| RenalGuardIntravenous saline hydration matched with urine output, using the device Renalguard | Device | RenalGuard |
Primary outcome
Incidence of contrast-induced nephropathy
Time frame: 72 hours
Contrast-induced nephropathy defined as an increase of serum creatinine of 0.5mg/dl or 25% in pre procedure serum creatinine at 72h after procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2014.
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.
Vitor O Gomes, MD,PhD principal investigator
Hospital Sao Lucas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing RenalGuard in people with Radiographic Contrast Agent Nephropathy, run by Hospital Sao Lucas da PUCRS at 1 site in Brazil.
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: status not confirmed, as of the sponsor's last update on 8 Jan 2014. 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 Brazil. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aryadina Piva, RN (55 51 33203494, pesquisa@cardiarte.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of contrast-induced nephropathy (time frame: 72 hours). 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 8 Jan 2014.