Acute Kidney InjuryPhase 4NCT02084771
Oral Salt and Water to Prevent Contrast Nephropathy
A Phase 4 study testing Intravenous Saline and Oral Salt and Water in people with Acute Kidney Injury, run by Ottawa Hospital Research Institute at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury
- What is being tested?
- Intravenous Saline and Oral Salt and Water
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2014to Jun 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Prevention of Acute Kidney Injury Following Contrast-Enhanced Computed Tomography: A Pilot Trial of Oral Fluid Versus Intravenous Saline
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.
Read the 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
- Being tested
- Intravenous Saline, Oral Salt and Water
- Keywords
- contrast nephropathy, contrast induced acute kidney injury, acute kidney injury, prophylaxis, randomized trial
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous SalineDrug
Also called normal saline, 0.9% saline, intravenous hydration, volume expansion
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.
Oral Salt and WaterBiological
Oral salt capsules and water, based on patient weight
| Study group | Role | What they receive |
|---|---|---|
| Oral Salt and Water | Experimental | 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. Receives: Biological: Oral Salt and Water |
| Intravenous Saline | Active comparator | 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. Receives: Drug: Intravenous Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 months
Secondary outcomes (1)
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.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2014 (estimated)
- Study startOct 2014
- Primary completionDec 2015
- Study completionJun 2016 (estimated)
Why it stopped: The recruitment rate was very slow, and it was concluded that it was not feasible to do this trial.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Swapnil Hiremath, MD MPH, Principal investigator, Ottawa Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02084771
- Sponsor's protocol ID
- OHRI-1777
- Status last verified
- Mar 2016
- First submitted
- 5 Nov 2013
- Last updated
- 31 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 25883789
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prevention of Acute Kidney Injury Following Contrast-Enhanced Computed Tomography: A Pilot Trial of Oral Fluid Versus Intravenous Saline
- ClinicalTrials.gov ID
- NCT02084771
- Acronym / sponsor ID
- OHRI-1777
- Conditions
- Acute Kidney Injury
- Keywords
- contrast nephropathy, contrast induced acute kidney injury, acute kidney injury, prophylaxis, randomized trial
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The recruitment rate was very slow, and it was concluded that it was not feasible to do this trial.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Jun 2016 (estimated)
- First posted
- 12 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral Salt and Water | Experimental | Biological: Oral Salt and WaterOral 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. |
| Intravenous Saline | Active comparator | Drug: Intravenous SalinePatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intravenous SalineAlso: normal saline, 0.9% saline, intravenous hydration, volume expansionPatients 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. | Drug | Intravenous Saline |
| Oral Salt and WaterOral salt capsules and water, based on patient weight | Biological | Oral Salt and Water |
Primary outcome
Feasibility (recruitment rate, adherence to intervention and completeness of follow-up)
Time frame: 24 months
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.
1 secondary outcome
Safety
Time frame: 24 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2016.
- Background: PubMed 25883789Swapnil 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Swapnil Hiremath, MD MPH principal investigator
Ottawa Hospital Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Intravenous Saline and Oral Salt and Water in people with Acute Kidney Injury, run by Ottawa Hospital Research Institute at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 31 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility (recruitment rate, adherence to intervention and completeness of follow-up) (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02084771, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2016.