Acute Kidney Injury Following Administration of Contrast Media
Conditions
Keywords
non-inferiorty, randomized controlled trial, contrast associated acute kidney injury, contrast agents, hydration
Brief summary
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.
Interventions
DRUGBolus 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.
DRUGContinuous 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.
Sponsors
Yunus Emre Gemici
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Participants Who Developed Contrast-Associated Acute Kidney Injury (CA-AKI) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Participants Who Required Dialysis | 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. |
| All-Cause Mortality Rate | 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. |
Countries
Turkey (Türkiye)
Outcome results
None listed