Oral vs. Intravenous Hydration to Prevent Contrast-Associated Acute Kidney Injury in the ED

March 5, 2026 updated by: Gaziosmanpasa Research and Education Hospital

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.

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

198

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • Gaziosmanpasa
      • Istanbul, Gaziosmanpasa, Turkey (Türkiye), 34255
        • Recruiting
        • Gaziosmanpasa Training and Research Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Oral Hydration Therapy
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.
Dietary supplement: Water
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.
Active Comparator: IV Hydration Therapy
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.
Other: %0,9 NaCl
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
48 to 72 hours after contrast media administration

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
New-Onset Dialysis Requirement or Mortality
Time Frame: Within 30-45 days post-procedure
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.
Within 30-45 days post-procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gaziosmanpasa Research and Education Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 7, 2025

Primary Completion (Estimated)

November 7, 2026

Study Completion (Estimated)

December 7, 2026

Study Registration Dates

First Submitted

February 17, 2026

First Submitted That Met QC Criteria

March 5, 2026

First Posted (Actual)

March 9, 2026

Study Record Updates

Last Update Posted (Actual)

March 9, 2026

Last Update Submitted That Met QC Criteria

March 5, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E-66291034-202.3.02-7615

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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