Acute Kidney InjuryPhase 4NCT02225431
Personalized Versus Standard Hydration for Prevention of CI-AKI: a Randomized Trial With Bioimpedance Analysis
A Phase 4 study testing sodium chloride infusion in people with Acute Kidney Injury, run by Ospedale Misericordia e Dolce at 1 site in Italy.
Trial summary
The aim of this study was to evaluate, in patients with "lower fluid status" defined by bioimpedance analysis, whether two different protocol of IV isotonic saline infusion are associated with different volume expansion and differing risks for CI-AKI in patients undergoing coronary angiographic procedures. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Acute Kidney Injury
- What is being tested?
- sodium chloride infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 296 participants
- Where
- 1 siteItaly
- Study dates
- Sep 2012to Apr 2015
- Phase
- Phase 4
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- consecutive patients admitted in Cardiology Unit for coronary or peripheral angiography with "lower fluid status" defined on the basis bio-impedance analysis (Male with resistance/height ratio > 315 Ohm/meter and Female > 380 Ohm/meter).
Who cannot join
- contrast medium administration within the 10 days
- end stage renal failure requiring dialysis
- refused to give informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Personalized Versus Standard Hydration for Prevention of Contrast Induced Acute Kidney Injury. A Randomized Trial With Bioimpedance Analysis.
The aim of this study was to evaluate, in patients with "lower fluid status" defined by bioimpedance analysis, whether two different protocol of IV isotonic saline infusion are associated with different volume expansion and differing risks for CI-AKI in patients undergoing coronary angiographic procedures.
Read the detailed description
Iodinated contrast media are a well-recognized cause of iatrogenic acute kidney injury in patients undergoing imaging diagnostic or therapeutic procedures (contrast-induced acute kidney injury, CI-AKI).
Several protocols have been tested for the prevention of CI-AKI, including periprocedural hydration with isotonic saline or sodium bicarbonate, antioxidant compounds, use of low- or iso-osmolar contrast agents, and hemofiltration or dialysis. The results of these interventions and strategies have been often disappointing or inconclusive and intravenous volume expansion remains the only therapy of undisputed efficacy.
Bioimpedance analysis is an inexpensive, rapid, and accurate tool for evaluating a patient's hydration status, and can be performed at the bedside within minutes [Maioli, JACC 1014;63:1387-94]. In this study we defined patients with "lower fluid status" with high risk of CI-AKI (Male with resistance/height ratio > 315 Ohm/meter and Female > 380 Ohm/meter). BIVA may represent the optimal tool to monitor the adequacy of volume expansion and protective strategy delivery.
However, most hydration protocols rely on a "one size fits all" approach with a fixed volume and time of infusion without an assessment of whether adequate hydration was achieved. This practice risks either under-hydration without true amelioration of CI-AKI risk or over-hydration with risk of adverse outcomes.
Thus, on the basis of results of BIVA testing a randomized fluid infusion plan is prescribed.
- Conditions
- Acute Kidney Injury
- Being tested
- sodium chloride infusion
- Keywords
- Contrast-induced nephropathy, Contrast-Induced acute kidney injury, Contrast media, Angiography, Coronary percutaneous intervention
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sodium chloride infusionDrug
| Study group | Role | What they receive |
|---|---|---|
| Standard saline infusion | Active comparator | All patients received standard intravenous saline hydration (0.9% sodium chloride, 1 ml/kg/h for 12 hours before and after procedure) Receives: Drug: sodium chloride infusion |
| Double saline infusion | Experimental | All patients received double dose of intravenous saline hydration (0.9% sodium chloride, 2 ml/kg/h for 12 hours before and after procedure) Receives: Drug: sodium chloride infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of contrast-induced acute kidney injury
contrast acute kidney injury is defined as an increase in serum Cystatin C concentration 10% above the baseline value at 24 hours after administration of contrast medium
Measured: 1 day
Secondary outcomes (1)
Adverse clinical events
adverse clinical events within 1 month including in-hospital death and need for dialysis or hemofiltration
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2014 (estimated)
- Study startSep 2012
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Kidney InjuryStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 296 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ospedale Misericordia e Dolce
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mauro Maioli, Ospedale Misericordia e Dolce
- Investigators
- Mauro Maioli, MD, Principal investigator, Ospedale S. Stefano - Prato - Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02225431
- Sponsor's protocol ID
- Prato0706
- Other IDs
- 2013/1
- Status last verified
- Oct 2015
- First submitted
- 24 Aug 2014
- Last updated
- 16 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Maioli M, Toso A, Leoncini M, Musilli N, Bellandi F, Rosner MH, McCullough PA, Ronco C. Pre-procedural bioimpedance vectorial analysis of fluid status and prediction of contrast-induced acute kidney injury. J Am Coll Cardiol. 2014 Apr 15;63(14):1387-94. doi: 10.1016/j.jacc.2014.01.025. Epub 2014 Feb 12.
PubMed 24530668Maioli M, Toso A, Leoncini M, Musilli N, Grippo G, Ronco C, McCullough PA, Bellandi F. Bioimpedance-Guided Hydration for the Prevention of Contrast-Induced Kidney Injury: The HYDRA Study. J Am Coll Cardiol. 2018 Jun 26;71(25):2880-2889. doi: 10.1016/j.jacc.2018.04.022.
PubMed 29929610
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Versus Standard Hydration for Prevention of Contrast Induced Acute Kidney Injury. A Randomized Trial With Bioimpedance Analysis.
- ClinicalTrials.gov ID
- NCT02225431
- Acronym / sponsor ID
- Prato0706
- Conditions
- Acute Kidney Injury
- Keywords
- Contrast-induced nephropathy, Contrast-Induced acute kidney injury, Contrast media, Angiography, Coronary percutaneous intervention
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 296 participants (actual)
- Lead sponsor
- Ospedale Misericordia e DolceUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 26 Aug 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 aim of this study was to evaluate, in patients with "lower fluid status" defined by bioimpedance analysis, whether two different protocol of IV isotonic saline infusion are associated with different volume expansion and differing risks for CI-AKI in patients undergoing coronary angiographic procedures.
Detailed description
Iodinated contrast media are a well-recognized cause of iatrogenic acute kidney injury in patients undergoing imaging diagnostic or therapeutic procedures (contrast-induced acute kidney injury, CI-AKI).
Several protocols have been tested for the prevention of CI-AKI, including periprocedural hydration with isotonic saline or sodium bicarbonate, antioxidant compounds, use of low- or iso-osmolar contrast agents, and hemofiltration or dialysis. The results of these interventions and strategies have been often disappointing or inconclusive and intravenous volume expansion remains the only therapy of undisputed efficacy.
Bioimpedance analysis is an inexpensive, rapid, and accurate tool for evaluating a patient's hydration status, and can be performed at the bedside within minutes [Maioli, JACC 1014;63:1387-94]. In this study we defined patients with "lower fluid status" with high risk of CI-AKI (Male with resistance/height ratio > 315 Ohm/meter and Female > 380 Ohm/meter). BIVA may represent the optimal tool to monitor the adequacy of volume expansion and protective strategy delivery.
However, most hydration protocols rely on a "one size fits all" approach with a fixed volume and time of infusion without an assessment of whether adequate hydration was achieved. This practice risks either under-hydration without true amelioration of CI-AKI risk or over-hydration with risk of adverse outcomes.
Thus, on the basis of results of BIVA testing a randomized fluid infusion plan is prescribed.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard saline infusion | Active comparator | Drug: sodium chloride infusionAll patients received standard intravenous saline hydration (0.9% sodium chloride, 1 ml/kg/h for 12 hours before and after procedure) |
| Double saline infusion | Experimental | Drug: sodium chloride infusionAll patients received double dose of intravenous saline hydration (0.9% sodium chloride, 2 ml/kg/h for 12 hours before and after procedure) |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- consecutive patients admitted in Cardiology Unit for coronary or peripheral angiography with "lower fluid status" defined on the basis bio-impedance analysis (Male with resistance/height ratio > 315 Ohm/meter and Female > 380 Ohm/meter).
Key exclusion criteria (3 listed)
- contrast medium administration within the 10 days
- end stage renal failure requiring dialysis
- refused to give informed consent
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 infusion | Drug | Double saline infusion, Standard saline infusion |
Primary outcome
Incidence of contrast-induced acute kidney injury
Time frame: 1 day
contrast acute kidney injury is defined as an increase in serum Cystatin C concentration 10% above the baseline value at 24 hours after administration of contrast medium
1 secondary outcome
Adverse clinical events
Time frame: 1 month
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 16 Oct 2015.
- Background: PubMed 24530668Maioli M, Toso A, Leoncini M, Musilli N, Bellandi F, Rosner MH, McCullough PA, Ronco C. Pre-procedural bioimpedance vectorial analysis of fluid status and prediction of contrast-induced acute kidney injury. J Am Coll Cardiol. 2014 Apr 15;63(14):1387-94. doi: 10.1016/j.jacc.2014.01.025. Epub 2014 Feb 12.
- Derived from this study: PubMed 29929610Maioli M, Toso A, Leoncini M, Musilli N, Grippo G, Ronco C, McCullough PA, Bellandi F. Bioimpedance-Guided Hydration for the Prevention of Contrast-Induced Kidney Injury: The HYDRA Study. J Am Coll Cardiol. 2018 Jun 26;71(25):2880-2889. doi: 10.1016/j.jacc.2018.04.022.
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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.
Mauro Maioli, MD principal investigator
Ospedale S. Stefano - Prato - Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing sodium chloride infusion in people with Acute Kidney Injury, run by Ospedale Misericordia e Dolce at 1 site in Italy.
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 1 inclusion and 3 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 16 Oct 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 Italy. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Incidence of contrast-induced acute kidney injury (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02225431, which also lists 2 linked publications.
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 16 Oct 2015.