Comparison of Bolus and Continuous Hydration Regimens for the Prevention of Contrast-Associated Acute Kidney Injury in the Emergency Department

December 12, 2025 updated by: Yunus Emre Gemici

Comparison of Bolus and Continuous Hydration Regimens for the Prevention of Contrast-Associated Acute Kidney Injury in the Emergency Department: A Randomized Controlled Non-Inferiority Trial

A single-center, prospective, open-label, non-inferiority randomized controlled clinical trial was conducted at the ED of a tertiary hospital. The ED staff consisted of a mix of emergency medicine specialists, emergency medicine residents, and general practitioners.

Between August 10, 2024, and March 26, 2025, patients aged 18 and over who presented to the ED with creatinine levels above the reference range (1.2 mg/dl in men and 1.1 mg/dl in women) and underwent contrast-enhanced tomography were deemed eligible for inclusion in the study.

Eligible patients were randomly allocated in a 1:1 ratio to receive either bolus hydration or continuous hydration therapy. Permuted block randomization was employed at each participating site to distribute patients, stratified by age groups (18-44, 45-59, 60-74, and 75 years and older) and gender. This study did not use blinding. Both the implementers of the intervention and the researchers evaluating the outcome measures are aware of the intervention groups.

After the patients were divided into two groups, one group received bolus hydration therapy while the other group received continuous hydration therapy.

According to the literature, individuals with an ejection fraction of less than 40% got a half-dose hydration protocol.

The IV contrast agent used in the study was iohexol, which belongs to the non-ionic low osmolar contrast agent group. 300 mgI/ml 100 ml solutions were used, and the dose was adjusted between 80 and 100 ml depending on the imaging and the patient. In the majority of patients, 100 ml of contrast was administered, with an average of 98 ml of solution given in the bolus hydration group and an average of 96 ml of solution given in the continuous hydration group.

Patients were given control forms to provide follow-up blood samples 48-72 hours later and were asked to present to the ED with the form on the specified date. To inquire about the development of dialysis needs and mortality status, patients were contacted 30 days later to gather information.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

285

Phase

  • Phase 4

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)
      • Istanbul, Turkey (Türkiye), 34255
        • Gaziosmanpaşa Training and Research Hospital

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:

  • Presented to the Emergency Department creatinine levels above the reference range (1.2 mg/dl in men and 1.1 mg/dl in women)
  • Underwent contrast-enhanced tomography

Exclusion Criteria:

  • Pregnancy
  • Known allergy history to contrast agents
  • Exposure to contrast agents within the last 72 hours
  • Being on dialysis due to end-stage kidney disease
  • Presenting with decompensated heart failure
  • Patients who were unable to provide informed consent

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: Bolus hydration therapy
In the Bolus hydration therapy group, 500 ml of 0.9% saline treatment was started half an hour before the procedure and after the procedure, 1000 ml of 0.9% saline treatment was continued at a rate of 500 ml/h to be completed in 2 hours. A total of 1500 ml 0.9% saline hydration therapy was administered over 2.5 hours. According to the literature, individuals with an ejection fraction of less than 40% got a half-dose hydration protocol. In the bolus hydration group, 250 ml of treatment was administered half an hour before the procedure, and hydration was continued at a rate of 250 ml/h for 2 hours after the procedure.
Drug: Bolus hydration therapy
In the Bolus hydration therapy group, 500 ml of 0.9% saline treatment was started half an hour before the procedure and after the procedure, 1000 ml of 0.9% saline treatment was continued at a rate of 500 ml/h to be completed in 2 hours. A total of 1500 ml 0.9% saline hydration therapy was administered over 2.5 hours. According to the literature, individuals with an ejection fraction of less than 40% got a half-dose hydration protocol. In the bolus hydration group, 250 ml of treatment was administered half an hour before the procedure, and hydration was continued at a rate of 250 ml/h for 2 hours after the procedure.
Active Comparator: Continuous hydration therapy
In the Continuous hydration therapy group, saline treatment started 2 hours before the intravenous (IV) contrast agent application at a rate of 150 ml/h, and hydration was applied for 8 more hours after the procedure at the same rate. A total of 1500 ml 0.9% saline hydration therapy was administered over 10 hours. According to the literature, individuals with an ejection fraction of less than 40% got a half-dose hydration protocol. In the continuous hydration group, 75 ml/h of hydration was administered for 2 hours before the procedure and for 8 hours after the procedure.
Drug: Continuous hydration therapy
In the Continuous hydration therapy group, saline treatment started 2 hours before the intravenous (IV) contrast agent application at a rate of 150 ml/h, and hydration was applied for 8 more hours after the procedure at the same rate. A total of 1500 ml 0.9% saline hydration therapy was administered over 10 hours. According to the literature, individuals with an ejection fraction of less than 40% got a half-dose hydration protocol. In the continuous hydration group, 75 ml/h of hydration was administered for 2 hours before the procedure and for 8 hours after the procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of Participants Who Developed Contrast-Associated Acute Kidney Injury (CA-AKI)
Time Frame: From enrollment to the end of treatment at 1 week
The primary outcome of our study was the development of CA-AKI, defined as an increase in serum creatinine value by ≥25% compared to baseline or an absolute increase in serum creatinine value by ≥0.5 mg/dL within 48-72 hours after contrast administration.
From enrollment to the end of treatment at 1 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of Participants Who Required Dialysis
Time Frame: From enrollment to the end of treatment at 1 month
Patients were contacted by phone 1 month after the procedure and asked about the development of dialysis needs within that 1-month period.
From enrollment to the end of treatment at 1 month
All-Cause Mortality Rate
Time Frame: From enrollment to the end of treatment at 1 month
Patients were contacted by phone 1 month after the procedure and asked about the all-cause Mortality within that 1-month period.
From enrollment to the end of treatment at 1 month

Collaborators and Investigators

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

Sponsor

Yunus Emre Gemici

Investigators

  • Study Director: Mustafa Çalık, MD, Assoc. Prof., Department of Emergency Medicine Gaziosmanpaşa Training and Research Hospital, İstanbul, Türkiye

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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)

August 10, 2024

Primary Completion (Actual)

March 29, 2025

Study Completion (Actual)

April 26, 2025

Study Registration Dates

First Submitted

December 2, 2025

First Submitted That Met QC Criteria

December 12, 2025

First Posted (Actual)

December 16, 2025

Study Record Updates

Last Update Posted (Actual)

December 16, 2025

Last Update Submitted That Met QC Criteria

December 12, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • E-66291034-202.3.02-4819

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared because the study involves single-center clinical data without a dedicated data-sharing infrastructure, and sharing these data may pose risks to participant privacy despite de-identification efforts.

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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