Contrast Induced Acute Kidney InjuryPhase 3HYDRAREANCT01636089
Bicarbonates Versus Saline for Contrast Induced Acute Kidney Injury Prevention in Intensive Care Unit
A Phase 3 study testing bicarbonates and saline in people with Contrast Induced Acute Kidney Injury, run by University Hospital, Caen at 3 sites in France.
Trial summary
The aim of this study is to compare bicarbonates versus saline for prevention of contrast induced acute kidney injury in critically ill patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Contrast Induced Acute Kidney Injury
- What is being tested?
- bicarbonates and saline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 3 sitesFrance
- Study dates
- Feb 2012to Jan 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
- patient > 18 years old
- in intensive care unit since 24h and for up to 48 hours
- with contrast medium injection
Who cannot join
- patient under renal replacement therapy
- rise in creatinine > 26µmol/L within 48hours
- anuria within 12 hours
- cardiogenic pulmonary oedema
- pH > 7.50 or kaliemia < 3mmol/L
- pregnancy
Trial locations and contacts
3 sites in 1 country.
France3 sites
Medical Intensive Care Unit
Caen, 14033
Surgical Intensive Care Unit
Caen, 14033
Intensive care unit
Saint-Lô, 50000
About this study
The aim of this study is to compare bicarbonates versus saline for prevention of contrast induced acute kidney injury in critically ill patients.
- Conditions
- Contrast Induced Acute Kidney Injury
- Being tested
- bicarbonates, saline
- Keywords
- intensive care unit
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bicarbonatesDrug
sodium bicarbonates 1,4%
salineDrug
sodium chloride 0,9%
| Study group | Role | What they receive |
|---|---|---|
| bicarbonates | Experimental | sodium bicarbonates 1,4% Receives: Drug: bicarbonates |
| saline | Active comparator | sodium chloride 0,9% Receives: Drug: saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
contrast induced acute kidney injury
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 posted10 Jul 2012 (estimated)
- Study startFeb 2012
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Contrast Induced Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe sponsor's other registered studies.
- 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
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01636089
- Sponsor's protocol ID
- 2011-A00227-34
- Acronym
- HYDRAREA
- Status last verified
- Feb 2015
- First submitted
- 15 Feb 2012
- Last updated
- 17 Feb 2026
- Results posted
- No
Publications
Timal RJ, Kooiman J, Sijpkens YWJ, de Vries JPM, Verberk-Jonkers IJAM, Brulez HFH, van Buren M, van der Molen AJ, Cannegieter SC, Putter H, van den Hout WB, Jukema JW, Rabelink TJ, Huisman MV. Effect of No Prehydration vs Sodium Bicarbonate Prehydration Prior to Contrast-Enhanced Computed Tomography in the Prevention of Postcontrast Acute Kidney Injury in Adults With Chronic Kidney Disease: The Kompas Randomized Clinical Trial. JAMA Intern Med. 2020 Apr 1;180(4):533-541. doi: 10.1001/jamainternmed.2019.7428.
PubMed 32065601
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bicarbonates Versus Saline for Contrast Induced Acute Kidney Injury Prevention in Intensive Care Unit
- ClinicalTrials.gov ID
- NCT01636089
- Acronym / sponsor ID
- HYDRAREA / 2011-A00227-34
- Conditions
- Contrast Induced Acute Kidney Injury
- Keywords
- intensive care unit
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 10 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 aim of this study is to compare bicarbonates versus saline for prevention of contrast induced acute kidney injury in critically ill patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| bicarbonates | Experimental | Drug: bicarbonatessodium bicarbonates 1,4% |
| saline | Active comparator | Drug: salinesodium chloride 0,9% |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patient > 18 years old
- in intensive care unit since 24h and for up to 48 hours
- with contrast medium injection
Key exclusion criteria (6 listed)
- patient under renal replacement therapy
- rise in creatinine > 26µmol/L within 48hours
- anuria within 12 hours
- cardiogenic pulmonary oedema
- pH > 7.50 or kaliemia < 3mmol/L
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 |
|---|---|---|
| bicarbonatessodium bicarbonates 1,4% | Drug | bicarbonates |
| salinesodium chloride 0,9% | Drug | saline |
Primary outcome
contrast induced acute kidney injury
Time frame: 72 hours
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 17 Feb 2026.
- Results publication: PubMed 32065601Timal RJ, Kooiman J, Sijpkens YWJ, de Vries JPM, Verberk-Jonkers IJAM, Brulez HFH, van Buren M, van der Molen AJ, Cannegieter SC, Putter H, van den Hout WB, Jukema JW, Rabelink TJ, Huisman MV. Effect of No Prehydration vs Sodium Bicarbonate Prehydration Prior to Contrast-Enhanced Computed Tomography in the Prevention of Postcontrast Acute Kidney Injury in Adults With Chronic Kidney Disease: The Kompas Randomized Clinical Trial. JAMA Intern Med. 2020 Apr 1;180(4):533-541. doi: 10.1001/jamainternmed.2019.7428.
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing bicarbonates and saline in people with Contrast Induced Acute Kidney Injury, run by University Hospital, Caen at 3 sites in France.
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 3 inclusion and 6 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 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. 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?
contrast induced acute kidney injury (time frame: 72 hours). 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 NCT01636089, which also lists 1 linked publication.
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 17 Feb 2026.