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

NCT05283512 | Recruiting DMC

• 2 other identifiers: S-20210126Danish Data Protection Act
• Study Type: interventional
• Target: 254
• Locations: 1 country
• Sites: 1

Brief Summary

The use of contrast media (CM) poses a risk of post-contrast acute kidney injury (PC-AKI), especially among patients chronic kidney disease (CKD). International guidelines recommend intravenous (IV) hydration with isotonic 0.9% NaCl for three-four hours pre-contrast and four-six hours post-contrast. Recent studies have proven that oral hydration or no hydration is non-inferior to IV hydration in patients with mild to moderate CKD (eGFR 30-60 mL/min/1.73 m2). However, no randomized controlled trials have evaluated alternative hydration methods against the guideline-recommended hydration protocol for the prevention of PC-AKI in high-risk patients with severe CKD (eGFR \< 30 mL/min/1.73 m2). Thus, the main focus of this trial is to evaluate IV hydration vs. oral hydration for their efficacy to prevent of PC-AKI in patients with severe CKD, who are scheduled for an elective contrast-enhanced CT-scan (CECT) with IV contrast-administration. Our research hypotheses consist of the following:

1. 1.Oral hydration with bottled tap water is non-inferior to IV-hydration with isotonic 0.9% NaCl as renal prophylaxis to prevent PC-AKI in patients with severe CKD referred for an elective IV CECT.
2. 2.NGAL and cfDNA are early and precise plasma and urinary biomarkers of PC-AKI with excellent diagnostic and prognostic accuracy for PC-AKI, dialysis, renal adverse events, hospitalization, progression in CKD-symptoms, and all-cause mortality.

Conditions

Contrast-induced Nephropathy; Kidney Injury; Kidney Failure, Chronic; Risk Reduction

Keywords

Intravenous; Contrast material; Computed Tomography; Cardiac CT; Prophylaxis; Oral Hydration; IV-hydration

Outcome Measures

Primary Outcomes (1)

• Incidence of PC-AKI

  The incidence of PC-AKI within the two arms

  2-5 days after IV CECT

Secondary Outcomes (20)

• Incidence of new onset need for dialysis treatment

  ≤ 30 days after IV CECT

• Renal adverse events

  25-40 days after IV CECT

• Hospitalization due to symptomatic heart failure

  ≤ 30 days after IV CECT

• All-cause mortality

  ≤ 30 days after IV CECT

• Hospitalization due to suspected hydration- or contrast-related sequelae

  ≤ 30 days after IV CECT

Study Arms (2)

IV-hydration group (standard of care according to international guidelines)

OTHER

The IV-hydration with isotonic 0.9% NaCl will be initiated three hours prior to the IV CECT and completed four hours after IV CECT (infusion rate of 1-3 mL/kg/hour). Patients are prescribed a fixed volume of 1000 mL, which is equally distributed before and after IV CECT (500 mL before and 500 mL after). Patients with heart failure (LVEF ≤ 40%) are prescribed a reduced volume of 500 mL, which is also equally distributed before and after IV CECT (250 mL before and 250 mL after).

Other: Preventive treatment with IV-hydration

Oral hydration group

ACTIVE COMPARATOR

The oral hydration regimen will be initiated one-two hours prior to IV CECT and completed within four hours after IV CECT. Patients are prescribed a fixed volume of 1000 mL, which is distributed equally before and after IV CECT (500 mL before and 500 mL after). Patients with heart failure (LVEF ≤ 40%) are prescribed a reduced volume of 500 mL, which is equally distributed before and after IV CECT (250 mL before and 250 mL after).

Other: Preventive treatment with oral hydration

Interventions

Preventive treatment with IV-hydration OTHER

IV hydration with isotonic 0.9% NaCl

IV-hydration group (standard of care according to international guidelines)

Preventive treatment with oral hydration OTHER

Oral hydration with regular bottled water

Oral hydration group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• eGFR \< 30 mL/min/1.73 m2
• Scheduled for elective IV CECT
• Age ≥ 18
• Signed informed consent

You may not qualify if:

• Allergy to Iodine
• Pregnancy
• Active dialysis treatment
• Acute infectious or inflammatory disease
• Acute pre- and/or post-renal kidney failure
• Unable to understand study information

Sponsors & Collaborators

• Odense University Hospital: lead
• Department of Nephrology, Odense University Hospital: collaborator
• Department of Clinical Genetics, Odense University Hospital: collaborator
• The A.P. Moller Foundation: collaborator
• The Research Counsil of Odense University Hospital: collaborator
• Copenhagen University's Research Foundation for Medical Students: collaborator
• Helen and Ejnar Bjørnow's Foundation: collaborator
• Novo Nordisk A/S: collaborator
• Sophus Jacobsen and Astrid Jacobsen's Foundation: collaborator
• Region of Southern Denmark: collaborator

Study Sites (1)

Department of Cardiology

Odense C, Fyn, 5000, Denmark

RECRUITING

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Related Links

• OECD (2022), Computed tomography (CT) exams (indicator). doi: 10.1787/3c994537-en (Accessed on 02 February 2022).
• Kidney Disease Improving Global Outcomes. KDIGO clinical practice guideline for acute kidney injury
• European Society of Urogenital Radiology's Guidelines on Contrast Agents.
• American College of Radiology - Manual on Contrast Media 2023

MeSH Terms

Conditions

Kidney Failure, Chronic; Risk Reduction Behavior

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Central Study Contacts

Kristian Altern Øvrehus, Chief physician

CONTACT

+45 28305454; kristian.altern.ovrehus@rsyd.dk

Emil Johannes Ravn, BSc.Med.

CONTACT

+45 31476794; emil.johannes.ravn2@rsyd.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical student and clinical research assistant

Model Details: Patients are allocated to either oral- or IV-hydration

Study Record Dates

• First Submitted: February 25, 2022
• First Posted: March 17, 2022
• Study Start: April 20, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: August 1, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, ANALYTIC CODE
• Time Frame: TBA
• Access Criteria: TBA

Locations

DK (1)