A Phase 4 interventional study of Intravenous Saline and Oral Salt and Water in Acute Kidney Injury, sponsored by Ottawa Hospital Research Institute. Withdrawn at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-03-31.
Sponsored by Ottawa Hospital Research Institute · Phase 4, Interventional, and Prevention
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.
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.
1,595 studies on the registry are indexed under Acute Kidney Injury; 371 are open to participants now.
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Exclusion criteria:
Oral Salt and Water Loading: Participants randomized to this arm of the trial will receive 0.1 g/kg of salt (NaCl) and 12 mL/kg of water. Patients weighing more than 110 kg will receive the same amount as per a 110 kg patient. One third of the oral salt and water will be given before the CT and 2/3 post-CT as in the intravenous saline arm. Specifically, 0.03 g/kg of NaCl and 4 mL/kg of water in the one hour before CT and 0.07 g/kg of NaCl and 8 mL/kg of water taken over 2 hours post-CT. The ingestion of the oral salt and water will be directly observed by the study nurse to ensure adherence to the protocol.
Biological: Oral Salt and Water
Patients randomized to this arm will receive intravenous isotonic (0.9%) saline. The rate of isotonic saline will be 3 mL/kg give in 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.
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.
Also known as: normal saline, 0.9% saline, intravenous hydration, volume expansion
Oral salt capsules and water, based on patient weight
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 1. We can randomize 50 patients into this trial; 2. Trial participants have \>95% adherence to the fluid regimens and 3. After randomization, \<1% participants are lost to follow-up in terms of post-CT serum creatinine measurements.
Time frame: 24 months
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.
Time frame: 24 months
Plan to share: No
This study is withdrawn, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.
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Ottawa Hospital Research Institute