Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID05283512

Intravenous vs. Oral Hydration to Reduce the Risk of Post-Contrast Acute Kidney Injury After Intravenous Contrast-Enhanced Computed Tomography in Patients With Severe Chronic Kidney Disease (ENRICH): A Randomized Controlled Trial

Led by Odense University Hospital · Updated on 2025-08-01

254

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

Sponsors

O

Odense University Hospital

Lead Sponsor

D

Department of Nephrology, Odense University Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

This research aims to compare intravenous (IV) hydration and oral hydration to prevent post-contrast acute kidney injury (PC-AKI) in patients with severe chronic kidney disease (CKD) who are scheduled for an elective contrast-enhanced CT scan (CECT). The study focuses on patients with an estimated glomerular filtration rate (eGFR) below 30 mL/min/1.73 m2, who are at high risk for PC-AKI, a kidney injury that can occur after contrast media use. It also evaluates biomarkers NGAL and cfDNA for early detection and prognosis of PC-AKI and related outcomes. Participants will be randomly assigned to receive either IV hydration with isotonic 0.9% NaCl or oral hydration with bottled water. IV hydration starts three hours before and ends four hours after the CT scan, typically with 1000 mL divided equally before and after the scan; patients with heart failure receive a reduced volume of 500 mL. Oral hydration starts one to two hours before and completes within four hours after the scan, with similar volume adjustments. The study is an open-label, randomized controlled trial conducted at Odense University Hospital. During the study, patients will undergo blood and urine tests before, shortly after, and up to 30 days following the CT scan to monitor kidney function, biomarkers, and clinical outcomes including dialysis, hospitalization, and mortality. Follow-ups include medical interviews to assess CKD symptom progression. Patient data is collected via electronic health records and REDCap. Participants may leave the study anytime without consequences. The total follow-up period is 30 days post-CT scan with interim safety analyses planned.

CONDITIONS

Brief Title

Intravenous vs. Oral Hydration to Reduce the Risk of Post-Contrast Acute Kidney Injury After Intravenous Contrast-Enhanced Computed Tomography in Patients With Severe Chronic Kidney Disease

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • eGFR less than 30 mL/min/1.73 m2
  • Scheduled for elective intravenous contrast-enhanced CT scan
  • Age 18 years or older
  • Signed informed consent
Not Eligible

You will not qualify if you...

  • Allergy to iodine
  • Pregnancy
  • Currently receiving dialysis treatment
  • Acute infectious or inflammatory disease
  • Acute pre- or post-renal kidney failure
  • Unable to understand study information

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Eligibility is assessed from electronic health records and laboratory results less than seven days prior to the scheduled IV CECT.

Enrollment and Baseline Assessment

Duration - Within 7 to 14 days before IV CECT

Participants provide verbal and then written informed consent and receive a thorough presentation of the study. Baseline medical history, medication use, echocardiography, blood and urine samples are collected before the scheduled intravenous contrast-enhanced CT scan (IV CECT).

1 visit (in-person) for consent and baseline assessments

Preventive Hydration Treatment and IV CECT

Duration - Approximately 7 hours (starting up to 3 hours before IV CECT and completed 4 hours after IV CECT)

Participants receive preventive hydration treatment via either intravenous hydration or oral hydration starting hours before and continuing after the IV CECT procedure, which involves administration of contrast media.

1 visit (in-person) on the day of IV CECT with hydration treatment before and after the scan

Post-Procedure Monitoring and Follow-up

Duration - 30 days after IV CECT

Participants are monitored with blood sampling and clinical assessments to evaluate kidney function and detect any adverse events related to the contrast and hydration treatments.

3 to 5 visits (in-person) including visits at 2-3 days, 4-5 days, and 30 days after IV CECT; additional visits may occur if kidney function worsens

Trial Site Locations

Total: 1 location

1

Department of Cardiology

Odense C, Fyn, Denmark, 5000

Actively Recruiting

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Research Team

K

Kristian Altern Øvrehus, Chief physician

E

Emil Johannes Ravn, BSc.Med.

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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Published Research Related To This Trial

Post-contrast acute kidney injury - Part 1: Definition, clinical features, incidence, role of contrast medium and risk factors : Recommendations for updated ESUR Contrast Medium Safety Committee guidelines.

Aart J van der Molen, Peter Reimer, Ilona A Dekkers...

https://pubmed.ncbi.nlm.nih.gov/29426991

Post-contrast acute kidney injury. Part 2: risk stratification, role of hydration and other prophylactic measures, patients taking metformin and chronic dialysis patients : Recommendations for updated ESUR Contrast Medium Safety Committee guidelines.

Aart J van der Molen, Peter Reimer, Ilona A Dekkers...

https://pubmed.ncbi.nlm.nih.gov/29417249

Use of Intravenous Iodinated Contrast Media in Patients with Kidney Disease: Consensus Statements from the American College of Radiology and the National Kidney Foundation.

Matthew S Davenport, Mark A Perazella, Jerry Yee...

https://pubmed.ncbi.nlm.nih.gov/31961246