Renal InsufficiencyPhase 3NICIRNCT02872155
Comparative Study of the Efficacy of Oral Versus Intravenous Hydration as a Preventive Measure of Contrast-induced Nephropathy (CIN) in Patients With Renal Insufficiency (RI) Grade III Under Study Conducting Computed Tomography (CT)
A Phase 3 study testing Oral hydratation, Bicarbonate endovenous hydratation and Saline endovenous hydratation in people with Renal Insufficiency, run by David Garcia Cinca at 1 site in Spain.
Trial summary
This study evaluates if oral hydratation is as effective as endovenous hydratation in the prophylaxis of contrast-induced nephropathy in patients renal insufficiency grade III under study conducting contrasted computed tomography. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Renal Insufficiency
- What is being tested?
- Oral hydratation, Bicarbonate endovenous hydratation and Saline endovenous hydratation
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 264 participants
- Where
- 1 siteSpain
- Study dates
- 4 Jul 2017to 15 Jul 2019
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients of both sexes over 18 years
- Candidates for a study with computed tomography and intravenous contrast
- A glomerular filtration rate between 30 and 45 mL / min including both determinations
- They have signed the written informed consent after being informed of the objectives and the nature of the case or be unable to have the authorization or agreement of its
Who cannot join
- refuse to participate in the study
- pregnancy or lactation
- Other risk factors for Contrast Induced Nephropathy: diabetes mellitus type I, have an age of 75 years or above, heart failure (defined by a scale New York Heart Association 3 or 4), hypotension (defined as systolic blood pressure <100), being treated with nephrotoxic medications.
- Any disease or a history that, in the investigator's opinion, could confound the results of the study or pose an additional risk to patient treatment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Study of the Efficacy of Oral Versus Intravenous Hydration as a Preventive Measure of Contrast-induced Nephropathy (CIN) in Patients
This study evaluates if oral hydratation is as effective as endovenous hydratation in the prophylaxis of contrast-induced nephropathy in patients renal insufficiency grade III under study conducting contrasted computed tomography.
- Conditions
- Renal Insufficiency
- Being tested
- Oral hydratation, Bicarbonate endovenous hydratation, Saline endovenous hydratation
- Keywords
- contrast-induced nephropathy, renal insufficiency, computed tomography
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral hydratationOther
500 mL of water two hours before computed tomography and 2000 milliliters 24 hours after performing computed tomography
Bicarbonate endovenous hydratationDrug
Intravenous hydration: sodium (1.6 molar) Bicarbonate 3 mL / kg / h starting one hour before the computed tomography and sodium bicarbonate (1/6 M) 1 mL / kg / h during the hour after computed tomography.
Saline endovenous hydratationDrug
If there is contraindication for administration of bicarbonate the pattern of intravenous hydration is performed with saline solution: 3 ml / kg / h for 1 hour before the procedure and normal saline 1 mL / kg / hour for hour after computed tomography.
| Study group | Role | What they receive |
|---|---|---|
| Oral hydratation | Experimental | Not described Receives: Other: Oral hydratation |
| Endovenous hydratation | Active comparator | Not described Receives: Drug: Bicarbonate endovenous hydratation; Drug: Saline endovenous hydratation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of contrast induced nephropathy
Contrast induced nephropathy defined as a creatinine increase> 0.5 mg
/ dl comparing the initial blood test to the blood test performed after 48-72 hours to the completion of the computed tomography
Measured: 48-72 hours after the completion of the computed tomography
Secondary outcomes (3)
Need for hemodialysis
Need for hemodialysis for one month after completion of the computed tomography, among patients who have undergone oral or intravenous hydration
Measured: 15 days
Reversibility of contrast induced nephropathy
Defined as no increase in creatinine> 0.5 mg / dl compared to the initial analysis performed
Measured: 15 days
Proportion of adverse events
Presence of adverse events, grade 3 adverse events and serious adverse events related to the investigational products during the study follow-up
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2016 (estimated)
- Study start4 Jul 2017
- Primary completion15 Jul 2019
- Study completion15 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal InsufficiencyStudies 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
- 264 participants (actual)
Sponsor and investigators
- Lead sponsor
- David Garcia Cinca
- Sponsor type
- University, hospital or other
- Collaborators
- Fundacion Clinic per a la Recerca Biomédica
- Responsible party
- Sponsor-investigator, David Garcia Cinca, Hospital Clinic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02872155
- Sponsor's protocol ID
- NICIR
- Acronym
- NICIR
- Status last verified
- Jan 2021
- First submitted
- 16 Aug 2016
- Last updated
- 2 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of the Efficacy of Oral Versus Intravenous Hydration as a Preventive Measure of Contrast-induced Nephropathy (CIN) in Patients
- ClinicalTrials.gov ID
- NCT02872155
- Acronym / sponsor ID
- NICIR / NICIR
- Conditions
- Renal Insufficiency
- Keywords
- contrast-induced nephropathy, renal insufficiency, computed tomography
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 264 participants (actual)
- Lead sponsor
- David Garcia CincaUniversity, hospital or other
- Collaborators
- Fundacion Clinic per a la Recerca Biomédica
- Study start
- 4 Jul 2017 (actual)
- Primary completion
- 15 Jul 2019 (actual)
- Study completion
- 15 Jul 2019 (actual)
- First posted
- 19 Aug 2016 (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.
This study evaluates if oral hydratation is as effective as endovenous hydratation in the prophylaxis of contrast-induced nephropathy in patients renal insufficiency grade III under study conducting contrasted computed tomography.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral hydratation | Experimental | Other: Oral hydratation |
| Endovenous hydratation | Active comparator | Drug: Bicarbonate endovenous hydratation, Drug: Saline endovenous hydratation |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients of both sexes over 18 years
- Candidates for a study with computed tomography and intravenous contrast
- A glomerular filtration rate between 30 and 45 mL / min including both determinations
- They have signed the written informed consent after being informed of the objectives and the nature of the case or be unable to have the authorization or agreement of its
Key exclusion criteria (4 listed)
- refuse to participate in the study
- pregnancy or lactation
- Other risk factors for Contrast Induced Nephropathy: diabetes mellitus type I, have an age of 75 years or above, heart failure (defined by a scale New York Heart Association 3 or 4), hypotension (defined as systolic blood pressure <100), being treated with nephrotoxic medications.
- Any disease or a history that, in the investigator's opinion, could confound the results of the study or pose an additional risk to patient treatment.
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 |
|---|---|---|
| Oral hydratation500 mL of water two hours before computed tomography and 2000 milliliters 24 hours after performing computed tomography | Other | Oral hydratation |
| Bicarbonate endovenous hydratationIntravenous hydration: sodium (1.6 molar) Bicarbonate 3 mL / kg / h starting one hour before the computed tomography and sodium bicarbonate (1/6 M) 1 mL / kg / h during the hour after computed tomography. | Drug | Endovenous hydratation |
| Saline endovenous hydratationIf there is contraindication for administration of bicarbonate the pattern of intravenous hydration is performed with saline solution: 3 ml / kg / h for 1 hour before the procedure and normal saline 1 mL / kg / hour for hour after computed tomography. | Drug | Endovenous hydratation |
Primary outcome
Proportion of contrast induced nephropathy
Time frame: 48-72 hours after the completion of the computed tomography
Contrast induced nephropathy defined as a creatinine increase> 0.5 mg / dl comparing the initial blood test to the blood test performed after 48-72 hours to the completion of the computed tomography
3 secondary outcomes
Need for hemodialysis
Time frame: 15 days
Reversibility of contrast induced nephropathy
Time frame: 15 days
Proportion of adverse events
Time frame: 15 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2021.
- Individual participant dataSharing planned: Undecided
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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 Oral hydratation, Bicarbonate endovenous hydratation and Saline endovenous hydratation in people with Renal Insufficiency, run by David Garcia Cinca at 1 site in Spain.
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 4 inclusion and 4 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 2 Feb 2021. 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 Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Proportion of contrast induced nephropathy (time frame: 48-72 hours after the completion of the computed tomography). 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 2 Feb 2021; AzTrials last refreshed its copy on 7 Nov 2026.