Oral Salt and Water to Prevent Contrast Nephropathy

Acute Kidney Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02084771
• Other study ID #: OHRI-1777
• Status: Recruiting
• Phase: Phase 4
• First received: November 5, 2013
• Last updated: April 20, 2015
• Start date: October 2014
• Est. completion date: January 2017

Study information

• Verified date: April 2015
• Source: Ottawa Hospital Research Institute
• Contact: Swapnil Hiremath, MD MPH
• Phone: 613-737-8899
• Email: shiremath[@]Ottawahospital.on.ca
• Is FDA regulated: No
• Health authority: Canada: Ethics Review CommitteeCanada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: January 2017
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Chronic kidney disease (as defined by glomerular filtration rate (GFR) < 45 mL/min/1.73m2 using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula calculated on the day of randomization);

• Undergoing an outpatient intravenous contrast-enhanced CT of the chest or abdomen;

• Age = 18 years

Exclusion criteria:

• Inability to give informed consent;

• Previously enrolled in this study;

• Any contrast-enhanced test in previous 14 days (to exclude patients who might have ongoing AKI from previous contrast exposure) ;

• Congestive heart failure defined as New York Heart Association (NYHA) class III or worse 76;

• Uncontrolled hypertension defined as systolic blood pressure greater than 180 mm Hg or diastolic blood pressure greater than 110 mm Hg at screening;

• Receiving dialysis treatments.

• The Physician ordering the CT scan has also ordered IV Saline, sodium bicarbonate or n-acetyl cysteine.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Acute Kidney Injury

Intervention

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

Locations

Country	Name	City	State
Canada	Ottawa Hospital Research Institute	Ottawa	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Ottawa Hospital Research Institute

Country where clinical trial is conducted

Canada, 

References & Publications (1)

Swapnil H, Knoll GA, Kayibanda JF, Fergusson D, Chow BJ, Shabana W, Murphy E, Ramsay T, James M, White CA, Garg A, Wald R, Hoch J, Akbari A. Oral salt and water versus intravenous saline for the prevention of acute kidney injury following contrast-enhanced computed tomography: study protocol for a pilot randomized trial. Can J Kidney Health Dis. 2015 Apr 16;2:12. doi: 10.1186/s40697-015-0048-7. eCollection 2015. Erratum in: Can J Kidney Health Dis. 2015;2:39. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility (recruitment rate, adherence to intervention and completeness of follow-up)	The primary outcome for this pilot trial is feasibility (recruitment rate, adherence to intervention and completeness of follow-up).; We will aim to establish that; We can randomize 50 patients into this trial; Trial participants have >95% adherence to the fluid regimens and; After randomization, <1% participants are lost to follow-up in terms of post-CT serum creatinine measurements.	24 months	No
Secondary	Safety	The tolerability of both regimens will be assessed using participants' self-reported symptoms, such as nausea or gastrointestinal discomfort with the oral regimen and discomfort with the venipuncture with the intravenous regimen.	24 months	Yes