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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bolus hydration therapy | Experimental | 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. |
|
| Continuous hydration therapy | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bolus hydration therapy | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Participants Who Developed Contrast-Associated Acute Kidney Injury (CA-AKI) | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Participants Who Required Dialysis | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mustafa Çalık, MD, Assoc. Prof. | Department of Emergency Medicine Gaziosmanpaşa Training and Research Hospital, İstanbul, Türkiye | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gaziosmanpaşa Training and Research Hospital | Istanbul | 34255 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20574082 | Background | Katzberg RW, Newhouse JH. Intravenous contrast medium-induced nephrotoxicity: is the medical risk really as great as we have come to believe? Radiology. 2010 Jul;256(1):21-8. doi: 10.1148/radiol.10092000. No abstract available. | |
| 23322741 | Background | James MT, Samuel SM, Manning MA, Tonelli M, Ghali WA, Faris P, Knudtson ML, Pannu N, Hemmelgarn BR. Contrast-induced acute kidney injury and risk of adverse clinical outcomes after coronary angiography: a systematic review and meta-analysis. Circ Cardiovasc Interv. 2013 Feb;6(1):37-43. doi: 10.1161/CIRCINTERVENTIONS.112.974493. Epub 2013 Jan 15. |
| Label | URL |
|---|---|
| Related Info | View source |
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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.
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 12, 2026 | |
| Reset | Mar 31, 2026 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 7, 2024 |
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|
| Continuous hydration therapy | Drug | 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. |
|
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 |
| 35054347 | Background | Cho E, Ko GJ. The Pathophysiology and the Management of Radiocontrast-Induced Nephropathy. Diagnostics (Basel). 2022 Jan 12;12(1):180. doi: 10.3390/diagnostics12010180. |
| 38072210 | Background | Ehmann MR, Klein EY, Zhao X, Mitchell J, Menez S, Smith A, Levin S, Hinson JS. Epidemiology and Clinical Outcomes of Community-Acquired Acute Kidney Injury in the Emergency Department: A Multisite Retrospective Cohort Study. Am J Kidney Dis. 2024 Jun;83(6):762-771.e1. doi: 10.1053/j.ajkd.2023.10.009. Epub 2023 Dec 10. |
| 22064601 | Background | Levine GN, Bates ER, Blankenship JC, Bailey SR, Bittl JA, Cercek B, Chambers CE, Ellis SG, Guyton RA, Hollenberg SM, Khot UN, Lange RA, Mauri L, Mehran R, Moussa ID, Mukherjee D, Nallamothu BK, Ting HH. 2011 ACCF/AHA/SCAI Guideline for Percutaneous Coronary Intervention: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines and the Society for Cardiovascular Angiography and Interventions. Circulation. 2011 Dec 6;124(23):e574-651. doi: 10.1161/CIR.0b013e31823ba622. Epub 2011 Nov 7. No abstract available. |
| 30165437 | Background | Neumann FJ, Sousa-Uva M, Ahlsson A, Alfonso F, Banning AP, Benedetto U, Byrne RA, Collet JP, Falk V, Head SJ, Juni P, Kastrati A, Koller A, Kristensen SD, Niebauer J, Richter DJ, Seferovic PM, Sibbing D, Stefanini GG, Windecker S, Yadav R, Zembala MO; ESC Scientific Document Group. 2018 ESC/EACTS Guidelines on myocardial revascularization. Eur Heart J. 2019 Jan 7;40(2):87-165. doi: 10.1093/eurheartj/ehy394. No abstract available. |
| 7160191 | Background | Blackwelder WC. "Proving the null hypothesis" in clinical trials. Control Clin Trials. 1982 Dec;3(4):345-53. doi: 10.1016/0197-2456(82)90024-1. |
| 33516141 | Background | Sebastia C, Paez-Carpio A, Guillen E, Pano B, Garcia-Cinca D, Poch E, Oleaga L, Nicolau C. Oral hydration compared to intravenous hydration in the prevention of post-contrast acute kidney injury in patients with chronic kidney disease stage IIIb: A phase III non-inferiority study (NICIR study). Eur J Radiol. 2021 Mar;136:109509. doi: 10.1016/j.ejrad.2020.109509. Epub 2021 Jan 14. |
| 35620986 | Background | Lombardi M, Molisana M, Genovesi E, De Innocentiis C, Limbruno U, Misuraca L, Moretti L, Di Vito L, Renda G, Zimarino M, Di Nicola M, De Caterina R. Urine alkalinisation to prevent contrast-induced acute kidney injury: the prospective, randomised, controlled, open-label TEATE trial. EuroIntervention. 2022 Sep 20;18(7):562-573. doi: 10.4244/EIJ-D-22-00010. |
| 37699636 | Background | Ravn EJ, Hasific S, Thomassen M, Hjortebjerg R, Bach Laursen K, Diederichsen A, Bistrup C, Ovrehus KA. Intravenous versus oral hydration to reduce the risk of postcontrast acute kidney injury after intravenous contrast-enhanced CT in patients with severe chronic kidney disease (ENRICH): a study protocol for a single-centre, parallel-group, open-labelled non-inferiority randomised controlled trial in Denmark. BMJ Open. 2023 Sep 12;13(9):e074057. doi: 10.1136/bmjopen-2023-074057. |
| 38264052 | Background | Somkereki C, Palfi R, Scridon A. Prevention of contrast-associated acute kidney injury in an era of increasingly complex interventional procedures. Front Med (Lausanne). 2024 Jan 9;10:1180861. doi: 10.3389/fmed.2023.1180861. eCollection 2023. |
| 25018920 | Background | Section 4: Contrast-induced AKI. Kidney Int Suppl (2011). 2012 Mar;2(1):69-88. doi: 10.1038/kisup.2011.34. No abstract available. |
| 38649939 | Background | Li Y, Wang J. Contrast-induced acute kidney injury: a review of definition, pathogenesis, risk factors, prevention and treatment. BMC Nephrol. 2024 Apr 22;25(1):140. doi: 10.1186/s12882-024-03570-6. |
| 33060531 | Background | Arslan S, Yildiz A, Dalgic Y, Batit S, Kilicarslan O, Ser OS, Dalgic SN, Kocas C, Abaci O. Avoiding the emergence of contrast-induced acute kidney injury in acute coronary syndrome: routine hydration treatment. Coron Artery Dis. 2021 Aug 1;32(5):397-402. doi: 10.1097/MCA.0000000000000966. |
| 34509996 | Background | Liu Y, Tan N, Huo Y, Chen S, Liu J, Chen YD, Wu K, Wu G, Chen K, Ye J, Liang Y, Feng X, Dong S, Wu Q, Ye X, Zeng H, Zhang M, Dai M, Duan CY, Sun G, He Y, Song F, Guo Z, Chen PY, Ge J, Xian Y, Chen J. Hydration for prevention of kidney injury after primary coronary intervention for acute myocardial infarction: a randomised clinical trial. Heart. 2022 May 25;108(12):948-955. doi: 10.1136/heartjnl-2021-319716. |
| 37380233 | Background | Liu Y, Tan N, Huo Y, Chen SQ, Liu J, Wang Y, Li L, Tao JH, Su X, Zhang L, Li QX, Zhang JY, Guo YS, Du ZM, Zhou YP, Fang ZF, Xu GM, Liang Y, Tao L, Chen H, Ji Z, Han B, Chen PY, Ge JB, Han YL, Chen JY. Simplified Rapid Hydration Prevents Contrast-Associated Acute Kidney Injury Among CKD Patients Undergoing Coronary Angiography. JACC Cardiovasc Interv. 2023 Jun 26;16(12):1503-1513. doi: 10.1016/j.jcin.2023.03.025. |
| 37355592 | Background | Chen F, Lu J, Yang X, Liu D, Wang Q, Geng X, Xiao B, Zhang J, Liu F, Gu G, Cui W. Different hydration methods for the prevention of contrast-induced nephropathy in patients with elective percutaneous coronary intervention: a retrospective study. BMC Cardiovasc Disord. 2023 Jun 24;23(1):323. doi: 10.1186/s12872-023-03358-w. |
| 30135570 | Background | Hoste EAJ, Kellum JA, Selby NM, Zarbock A, Palevsky PM, Bagshaw SM, Goldstein SL, Cerda J, Chawla LS. Global epidemiology and outcomes of acute kidney injury. Nat Rev Nephrol. 2018 Oct;14(10):607-625. doi: 10.1038/s41581-018-0052-0. |
| 38158245 | Background | Batte A, Shahrin L, Claure-Del Granado R, Luyckx VA, Conroy AL. Infections and Acute Kidney Injury: A Global Perspective. Semin Nephrol. 2023 Sep;43(5):151466. doi: 10.1016/j.semnephrol.2023.151466. Epub 2023 Dec 28. |
| 34267223 | Background | Kellum JA, Romagnani P, Ashuntantang G, Ronco C, Zarbock A, Anders HJ. Acute kidney injury. Nat Rev Dis Primers. 2021 Jul 15;7(1):52. doi: 10.1038/s41572-021-00284-z. |
| 25018917 | Background | Section 1: Introduction and Methodology. Kidney Int Suppl (2011). 2012 Mar;2(1):13-18. doi: 10.1038/kisup.2011.31. No abstract available. |
| Dec 12, 2025 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 7, 2024 | Dec 12, 2025 | ICF_001.pdf |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 12, 2026 | Mar 31, 2026 |