Contrast-Associated Acute Kidney InjuryNCT07459413
Oral vs. Intravenous Hydration to Prevent Contrast-Associated Acute Kidney Injury in the ED
A study testing Water and %0,9 NaCl in people with Contrast-Associated Acute Kidney Injury and Contrast-induced Nephropathy, run by Gaziosmanpasa Research and Education Hospital at 1 site in Turkey (Türkiye).
Trial summary
This study is planned to be conducted by emergency physicians between November 7, 2025, and December 7, 2026. Inclusion and Exclusion Criteria The study will include adult patients aged 18 years and older who are considered at risk for Contrast-Associated Acute Kidney Injury (CA-AKI), with an estimated Glomerular… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Contrast-Associated Acute Kidney Injury, Contrast-induced Nephropathy
- What is being tested?
- Water and %0,9 NaCl
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 198 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 7 Nov 2025to 7 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Patients aged 18 years and older.
- Patients with an estimated Glomerular Filtration Rate (eGFR) between 15-59 mL/min/1.73 m².
- Patients undergoing contrast-enhanced computed tomography (CT) in the emergency department.
- Patients who have provided written informed consent.
Who cannot join
- Pregnant women.
- Patients with end-stage renal disease (ESRD) receiving dialysis or those with an eGFR <15 mL/min/1.73 m².
- Patients presenting with decompensated heart failure.
- Patients with a known allergy to iodinated contrast media.
- Patients with contrast media exposure within the last 72 hours.
- Patients for whom oral intake is contraindicated or who cannot tolerate oral intake
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Gaziosmanpasa Training and Research Hospital
Istanbul, Gaziosmanpasa, 34255
Alper G Cimen, MD, 90+5353054720, alpercimen24@gmail.com
About this study
Official title: Evaluation of the Effectiveness of Oral Hydration Compared to Intravenous Hydration in Preventing Contrast-Associated Acute Kidney Injury in the Emergency Department : A Randomized Controlled Non-Inferiority Trial
This study is planned to be conducted by emergency physicians between November 7, 2025, and December 7, 2026.
Inclusion and Exclusion Criteria The study will include adult patients aged 18 years and older who are considered at risk for Contrast-Associated Acute Kidney Injury (CA-AKI), with an estimated Glomerular Filtration Rate (eGFR) between 15-59 ml/min/1.73 m², a clinical indication for contrast-enhanced CT, and who have provided signed informed consent.
Read more
Exclusion criteria are as follows:
Pregnant women.
Patients with a known contrast media allergy.
Contrast media exposure within the last 72 hours.
End-stage renal disease (ESRD) with eGFR <15 ml/min/1.73 m² or those receiving dialysis.
Patients with clinical decompensated heart failure.
Patients for whom oral intake is contraindicated or not tolerated.
Randomization and Interventions Prior to randomization, the oral intake capacity of eligible patients will be verified. Participants will be randomized into two groups-IV hydration and oral hydration-at a 1:1 ratio using stratified block randomization based on age and gender.
IV Hydration Group: Isotonic 0.9% NaCl solution will be administered. The regimen consists of 3 ml/kg for 1 hour pre-procedure, followed by 2 ml/kg/hour for 4 hours post-procedure. Patients with an ejection fraction (EF) <40% will receive half-doses (1.5 ml/kg pre-procedure; 1 ml/kg/hour for 4 hours post-procedure).
Oral Hydration Group: Drinking water will be administered under nursing supervision. The regimen consists of 500 ml 1 hour pre-procedure and 125 ml/hour for 4 hours post-procedure. Patients with an EF <40% will receive half-doses (250 ml pre-procedure; 62.5 ml/hour post-procedure).
Follow-up and Outcome Measures Baseline renal function tests will be obtained from all patients prior to the protocol. Patients will be re-evaluated for CA-AKI via blood samples taken 48-72 hours after contrast administration.
Furthermore, eGFR changes will be calculated using the Modification of Diet in Renal Disease (MDRD) formula. Mehran Risk Scores will also be determined for each patient. Long-term outcomes, including progression to ESRD (requirement for dialysis) and mortality within 1 month, as well as creatinine levels between days 30-45, will be assessed.
- Being tested
- Water, %0,9 NaCl
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WaterDietary supplement
Participants in the oral hydration group will receive 500 mL of drinking water 1 hour before the contrast-enhanced CT procedure. Following the procedure, they will receive 125 mL/hour of water for a total of 4 hours under nursing supervision. For patients with an ejection fraction (EF) <40%, the hydration dose is halved: 250 mL before the procedure and 62.5 mL/hour for 4 hours post-procedure.
%0,9 NaClOther
Participants in the intravenous (IV) hydration group will receive isotonic 0.9% NaCl solution. The protocol consists of 3 mL/kg for 1 hour before the procedure, followed by 2 mL/kg/hour for 4 hours post-procedure. For patients with an ejection fraction (EF) <40%, the hydration dose is halved: 1.5 mL/kg before the procedure and 1 mL/kg/hour for 4 hours post-procedure.
| Study group | Role | What they receive |
|---|---|---|
| Oral Hydration Therapy | Experimental | Participants in the oral hydration group will receive 500 mL of drinking water 1 hour before the contrast-enhanced CT procedure. Following the procedure, they will receive 125 mL/hour of water for a total of 4 hours under nursing supervision. For patients with an ejection fraction (EF) <40%, the hydration dose is halved: 250 mL before the procedure and 62.5 mL/hour for 4 hours post-procedure. Receives: Dietary Supplement: Water |
| IV Hydration Therapy | Active comparator | Participants in the intravenous (IV) hydration group will receive isotonic 0.9% NaCl solution. The protocol consists of 3 mL/kg for 1 hour before the procedure, followed by 2 mL/kg/hour for 4 hours post-procedure. For patients with an ejection fraction (EF) <40%, the hydration dose is halved: 1.5 mL/kg before the procedure and 1 mL/kg/hour for 4 hours post-procedure. Receives: Other: %0,9 NaCl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Contrast-Associated Acute Kidney Injury (CA-AKI)
The percentage of participants who develop CA-AKI, defined by the ESUR 10.0 (2018) criteria as an absolute increase in serum creatinine of at least 0.3 mg/dL or a relative increase of at least 50% from the baseline value within 48-72 hours after contrast media administration.
Measured: 48 to 72 hours after contrast media administration
Secondary outcomes (1)
New-Onset Dialysis Requirement or Mortality
Number of participants requiring renal replacement therapy (dialysis) during the 30-45 day follow-up period and total number of deaths from any cause within 30-45 days after the procedure.
Measured: Within 30-45 days post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2026
- Study start7 Nov 2025
- Primary completion7 Nov 2026 (estimated)
- Study completion7 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Contrast-Associated 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 198 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gaziosmanpasa Research and Education Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07459413
- Sponsor's protocol ID
- E-66291034-202.3.02-7615
- Status last verified
- Feb 2026
- First submitted
- 17 Feb 2026
- Last updated
- 9 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of Oral Hydration Compared to Intravenous Hydration in Preventing Contrast-Associated Acute Kidney Injury in the Emergency Department : A Randomized Controlled Non-Inferiority Trial
- ClinicalTrials.gov ID
- NCT07459413
- Acronym / sponsor ID
- E-66291034-202.3.02-7615
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 198 participants (estimated)
- Lead sponsor
- Gaziosmanpasa Research and Education HospitalOther government
- Study start
- 7 Nov 2025 (actual)
- Primary completion
- 7 Nov 2026 (estimated)
- Study completion
- 7 Dec 2026 (estimated)
- First posted
- 9 Mar 2026 (actual)
- 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 is planned to be conducted by emergency physicians between November 7, 2025, and December 7, 2026.
Inclusion and Exclusion Criteria The study will include adult patients aged 18 years and older who are considered at risk for Contrast-Associated Acute Kidney Injury (CA-AKI), with an estimated Glomerular Filtration Rate (eGFR) between 15-59 ml/min/1.73 m², a clinical indication for contrast-enhanced CT, and who have provided signed informed consent.
Exclusion criteria are as follows:
Pregnant women.
Patients with a known contrast media allergy.
Contrast media exposure within the last 72 hours.
End-stage renal disease (ESRD) with eGFR <15 ml/min/1.73 m² or those receiving dialysis.
Patients with clinical decompensated heart failure.
Patients for whom oral intake is contraindicated or not tolerated.
Randomization and Interventions Prior to randomization, the oral intake capacity of eligible patients will be verified. Participants will be randomized into two groups-IV hydration and oral hydration-at a 1:1 ratio using stratified block randomization based on age and gender.
IV Hydration Group: Isotonic 0.9% NaCl solution will be administered. The regimen consists of 3 ml/kg for 1 hour pre-procedure, followed by 2 ml/kg/hour for 4 hours post-procedure. Patients with an ejection fraction (EF) <40% will receive half-doses (1.5 ml/kg pre-procedure; 1 ml/kg/hour for 4 hours post-procedure).
Oral Hydration Group: Drinking water will be administered under nursing supervision. The regimen consists of 500 ml 1 hour pre-procedure and 125 ml/hour for 4 hours post-procedure. Patients with an EF <40% will receive half-doses (250 ml pre-procedure; 62.5 ml/hour post-procedure).
Follow-up and Outcome Measures Baseline renal function tests will be obtained from all patients prior to the protocol. Patients will be re-evaluated for CA-AKI via blood samples taken 48-72 hours after contrast administration.
Furthermore, eGFR changes will be calculated using the Modification of Diet in Renal Disease (MDRD) formula. Mehran Risk Scores will also be determined for each patient. Long-term outcomes, including progression to ESRD (requirement for dialysis) and mortality within 1 month, as well as creatinine levels between days 30-45, will be assessed.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral Hydration Therapy | Experimental | Dietary Supplement: WaterParticipants in the oral hydration group will receive 500 mL of drinking water 1 hour before the contrast-enhanced CT procedure. Following the procedure, they will receive 125 mL/hour of water for a total of 4 hours under nursing supervision. For patients with an ejection fraction (EF) <40%, the hydration dose is halved: 250 mL before the procedure and 62.5 mL/hour for 4 hours post-procedure. |
| IV Hydration Therapy | Active comparator | Other: %0,9 NaClParticipants in the intravenous (IV) hydration group will receive isotonic 0.9% NaCl solution. The protocol consists of 3 mL/kg for 1 hour before the procedure, followed by 2 mL/kg/hour for 4 hours post-procedure. For patients with an ejection fraction (EF) <40%, the hydration dose is halved: 1.5 mL/kg before the procedure and 1 mL/kg/hour for 4 hours post-procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients aged 18 years and older.
- Patients with an estimated Glomerular Filtration Rate (eGFR) between 15-59 mL/min/1.73 m².
- Patients undergoing contrast-enhanced computed tomography (CT) in the emergency department.
- Patients who have provided written informed consent.
Key exclusion criteria (6 listed)
- Pregnant women.
- Patients with end-stage renal disease (ESRD) receiving dialysis or those with an eGFR <15 mL/min/1.73 m².
- Patients presenting with decompensated heart failure.
- Patients with a known allergy to iodinated contrast media.
- Patients with contrast media exposure within the last 72 hours.
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 |
|---|---|---|
| WaterParticipants in the oral hydration group will receive 500 mL of drinking water 1 hour before the contrast-enhanced CT procedure. Following the procedure, they will receive 125 mL/hour of water for a total of 4 hours under nursing supervision. For patients with an ejection fraction (EF) <40%, the hydration dose is halved: 250 mL before the procedure and 62.5 mL/hour for 4 hours post-procedure. | Dietary supplement | Oral Hydration Therapy |
| %0,9 NaClParticipants in the intravenous (IV) hydration group will receive isotonic 0.9% NaCl solution. The protocol consists of 3 mL/kg for 1 hour before the procedure, followed by 2 mL/kg/hour for 4 hours post-procedure. For patients with an ejection fraction (EF) <40%, the hydration dose is halved: 1.5 mL/kg before the procedure and 1 mL/kg/hour for 4 hours post-procedure. | Other | IV Hydration Therapy |
Primary outcome
Incidence of Contrast-Associated Acute Kidney Injury (CA-AKI)
Time frame: 48 to 72 hours after contrast media administration
The percentage of participants who develop CA-AKI, defined by the ESUR 10.0 (2018) criteria as an absolute increase in serum creatinine of at least 0.3 mg/dL or a relative increase of at least 50% from the baseline value within 48-72 hours after contrast media administration.
1 secondary outcome
New-Onset Dialysis Requirement or Mortality
Time frame: Within 30-45 days post-procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2026.
- Individual participant dataSharing planned: No
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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.
Gaziosmanpasa Training and Research Hospital
Istanbul, Turkey (Türkiye)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Water and %0,9 NaCl in people with Contrast-Associated Acute Kidney Injury and Contrast-induced Nephropathy, run by Gaziosmanpasa Research and Education Hospital at 1 site in Turkey (Türkiye).
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 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: looking for participants now, as of the sponsor's last update on 9 Mar 2026. 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 Turkey (Türkiye). 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Contrast-Associated Acute Kidney Injury (CA-AKI) (time frame: 48 to 72 hours after contrast media administration). 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 9 Mar 2026.