Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07459413

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gaziosmanpasa Training and Research Hospital

Istanbul, Gaziosmanpasa, 34255, Turkey (Türkiye)

Location status: Recruiting

Location contact

Alper G Cimen, MD

CONTACT

[email protected]

90+5353054720

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Water

Dietary 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 NaCl

Other

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Gaziosmanpasa Research and Education Hospital

Other Gov

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 9, 2026
Registry last updated
Mar 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.