Renal FailurePhase 3NCT01172353
Sodium Bicarbonate for Prevention of Contrast-Induced Nephropathy
A Phase 3 study testing sodium bicarbonate and saline in people with Renal Failure, 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 sodium bicarbonate is superior to 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
- Renal Failure
- What is being tested?
- sodium bicarbonate and saline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 301 participants
- Where
- 1 siteBrazil
- Study dates
- Jul 2004to Feb 2008
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 > 1.1 mg/dL
- glomerular filtration rate (GFR) < 50 mL/min
Who cannot join
- age < 18 years
- use of radiographic contrast media during the last 21 days
- history of dialysis
- cardiac insufficiency class III-IV
- emergency procedures
Trial locations and contacts
1 site in 1 country.
Brazil1 site
São Lucas Hospital - PUCRS University
Porto Alegre, Rio Grande do Sul, 90610-000
About this study
Official title: Hydration With Sodium Bicarbonate for Prevention of Contrast-Induced Nephropathy: A Multicenter Clinical Trial
The purpose of this study is to determine whether hydration with sodium bicarbonate is superior to hydration with saline to prevent contrast-induced nephropathy.
- Conditions
- Renal Failure
- Being tested
- sodium bicarbonate, saline
- Keywords
- contras-induced nephropathy
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sodium bicarbonateDrug
hydration with sodium bicarbonate 1ml/Kg/h for 6 hours
salineDrug
hydration with saline 1ml/Kg/h for 6 hours
| Study group | Role | What they receive |
|---|---|---|
| sodium bicarbonate | Experimental | hydration with sodium bicarbonate Receives: Drug: sodium bicarbonate |
| saline | Active comparator | hydration with saline 1ml/Kg/h for 6 hours Receives: Drug: saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Contrast-induced Nephropathy
rise in serum creatinine >0,5mg/dl
Measured: 48 hours
Secondary outcomes (1)
Dialysis During Hospitalization
Measured: During hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2010 (estimated)
- Study startJul 2004
- Primary completionJan 2008
- Study completionFeb 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Renal FailureStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 301 participants (actual)
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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01172353
- Sponsor's protocol ID
- HSaoLucas
- Status last verified
- Jan 2014
- First submitted
- 28 Jul 2010
- Last updated
- 19 Feb 2014
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hydration With Sodium Bicarbonate for Prevention of Contrast-Induced Nephropathy: A Multicenter Clinical Trial
- ClinicalTrials.gov ID
- NCT01172353
- Acronym / sponsor ID
- HSaoLucas
- Conditions
- Renal Failure
- Keywords
- contras-induced nephropathy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 301 participants (actual)
- Lead sponsor
- Hospital Sao Lucas da PUCRSUniversity, hospital or other
- Study start
- Jul 2004
- Primary completion
- Jan 2008 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 29 Jul 2010 (estimated)
- Results
- Posted 19 Feb 2014
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 sodium bicarbonate is superior to hydration with saline to prevent contrast-induced nephropathy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sodium bicarbonate | Experimental | Drug: sodium bicarbonatehydration with sodium bicarbonate |
| saline | Active comparator | Drug: salinehydration with saline 1ml/Kg/h for 6 hours |
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 > 1.1 mg/dL
- glomerular filtration rate (GFR) < 50 mL/min
Key exclusion criteria (5 listed)
- age < 18 years
- use of radiographic contrast media during the last 21 days
- history of dialysis
- cardiac insufficiency class III-IV
- 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 |
|---|---|---|
| sodium bicarbonatehydration with sodium bicarbonate 1ml/Kg/h for 6 hours | Drug | sodium bicarbonate |
| salinehydration with saline 1ml/Kg/h for 6 hours | Drug | saline |
Primary outcome
Contrast-induced Nephropathy
Time frame: 48 hours
rise in serum creatinine >0,5mg/dl
1 secondary outcome
Dialysis During Hospitalization
Time frame: During hospitalization
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 sodium bicarbonate and saline in people with Renal Failure, 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: finished, as of the sponsor's last update on 19 Feb 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?
Yes. Results are posted in the registry (first posted 19 Feb 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Contrast-induced Nephropathy (time frame: 48 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 19 Feb 2014.