NCT02084771

Oral Salt and Water to Prevent Contrast Nephropathy

The Prevention of Acute Kidney Injury Following Contrast-Enhanced Computed Tomography: A Pilot Trial of Oral Fluid Versus Intravenous Saline

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Ottawa Hospital Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this pilot trial is to determine the safety and feasibility of using oral salt and water loading compared to intravenous saline for the prevention of contrast-induced acute kidney injury in patients with chronic kidney disease receiving a contrast-enhanced CT scan.

Detailed description

Background: Intravenous saline is the accepted prophylactic measure for prevention of contrast-induced acute kidney injury. However, most trials for contrast nephropathy prevention have been in the setting of arterial contrast, such as with cardiac catheterization, and not with venous contrast, such as computed tomography (CT). There is insufficient data on effective prophylactic strategies to prevent acute kidney injury (AKI) following contrast-enhanced CT scans. Objective: The primary aim of this pilot trial is to determine the safety and feasibility of using oral salt and water loading compared to intravenous saline for the prevention of contrast-induced acute kidney injury in patients with chronic kidney disease (CKD) receiving a contrast-enhanced CT scan of the chest or abdomen. The results of the pilot trial will help us to plan and carry out a definitive efficacy trial to compare the two interventions. Design: A randomized controlled trial with two parallel arms. Study Population: 50 patients with chronic kidney disease (eGFR \< 45 mL/min/1.73m2) who are undergoing a contrast-enhanced CT scan. Intervention: Participants will be randomly allocated to receive either intravenous saline or oral salt and water loading. All participants will be administered an intravenous low-osmolar contrast medium as per recommended guidelines. Relevance: The results of this pilot trial will provide critical information to plan a definitive trial to test the efficacy of volume loading regimens to prevent acute kidney injury after contrast-enhanced CT scans. The current standard of care for chronic kidney disease patients who have contrast-enhanced CT scans is intravenous saline. This regimen requires significant health care resources as it requires a same-day hospital stay, nursing time as well as patient inconvenience. If the results of this study show that oral salt loading is effective as the standard intravenous saline, it would result in a significant reduction in the use of these resources. Given the large volume of CT scans performed in Canada and worldwide, this will result in a substantial cost savings to the healthcare system. We have established a network with acute kidney injury researchers at four other large academic health organizations across Canada in preparation for a definitive trial.

Conditions

• Acute Kidney Injury

Interventions

Type	Name	Description
DRUG	Intravenous Saline	Patients randomized to this arm will receive intravenous isotonic (0.9%) saline. The rate of isotonic saline will be 3 mL/kg given the one hour before CT and 1 mL/kg/hour for 6 hours post-CT as per Canadian guidelines. Patients weighing more than 110 kg will receive the rate as per a 110 kg patient. The dose will be rounded up to the nearest 5 mL.
BIOLOGICAL	Oral Salt and Water	Oral salt capsules and water, based on patient weight

Timeline

• Start date: 2014-10-01
• Primary completion: 2015-12-01
• Completion: 2016-06-01
• First posted: 2014-03-12
• Last updated: 2016-03-31

Locations

1 site across 1 country: Canada