Acute Kidney Injury (Nontraumatic)CVPNCT04592406
Data on the Prevention of Complications of Prophylactic Intravenous Hydration in Patients With eGFR < 30
An observational study of Acute Kidney Injury (Nontraumatic) and Contrast-induced Nephropathy, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
At Maastricht University Medical Centre (Maastricht UMC+) a specialised unit was established where a dual screening process including both renal and cardiac parameters is used to minimize the risk of contrast-induced acute kidney injury as well as the risk of prophylactic hydration in eGFR<30mL/min/1.73m2 patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury (Nontraumatic), Contrast-induced Nephropathy
- What is being tested?
- CVP screening
- How many people
- 443 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Dec 2018to 6 Jan 2023
- Phase
- Observational
- 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
Study population: patients with eGFR <30 mL/min/1.73m2 in absence of dialysis referred for a procedure with intravascular administration of iodinated contrast material at Maastricht UMC+
Who may be able to join
- eGFR <30 mL/min/1.73m2 in absence of dialysis
- referred for a procedure with intravascular administration of iodinated contrast material at Maastricht UMC+
Who cannot join
- age <18 years
- dialysis or pre-dialysis
- emergency or intensive care status
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Data on the Prevention of Complications of Prophylactic Intravenous Hydration in Patients With Estimated Glomerular Filtration Rate (eGFR) < 30 ml/Min/1.73m2 From the Maastricht UMC+ Contrast Voorbereidings Polikliniek
At Maastricht University Medical Centre (Maastricht UMC+) a specialised unit was established where a dual screening process including both renal and cardiac parameters is used to minimize the risk of contrast-induced acute kidney injury as well as the risk of prophylactic hydration in eGFR<30mL/min/1.73m2 patients. Very little data exists on patients with eGFR <30mL/min/1.73m2 in this context. The current study aims to describe post-contrast outcomes of patients to whom this screening method has been applied.
Read the detailed description
A large retrospective observational study, including 4-years of elective procedures with intravascular iodinated contrast administration in eGFR<30mL/min/1.73m2 patients at Maastricht UMC+, found that prophylactic intravenous hydration might confer some benefit for renal function. For patients who had received prophylactic hydration, adjusted odds ratios for risk of post-contrast acute kidney injury, and 1-month eGFR decline and dialysis were all lower than 1. These results were not significant, but suggest that hydration may be protective. On the other hand, adjusted odds ratios for all-cause mortality within 1-month post-contrast were higher than 1, with point estimates indicating a trend toward higher risk of short-term mortality after prophylaxis as compared to no prophylaxis. Confounding by indication may be responsible for the observed increased risk of short-term mortality, but complications of the prophylaxis did contribute towards the risk. Amongst the 281 eGFR<30mL/min/1.73m2 prophylaxis patients studied, 18 (6.4%) serious complications occurred: 3 arrhythmias, and 15 heart failures including 5 deaths. Of all 21 deaths recorded for the prophylaxis patients, 24% (5/21) were considered to be related to intravenous fluids. An exploration of differences in baseline characteristics between patients with and without serious complications suggested that these can be avoided if cardiac function parameters are given extra and individual attention before deciding whether to administer prophylaxis to high-risk patients with eGFR<30mL/min/1.73m2. At Maastricht UMC+ a specialised unit (called the CVP) was established where a dual screening process including both renal and cardiac parameters is used to minimize the risk of contrast-induced acute kidney injury as well as the risk of prophylactic hydration in eGFR<30mL/min/1.73m2 patients. In order to enable real function follow-up, the CVP registers data on all patients with eGFR <30 receiving intravascular iodinated contrast material, including acute patients who did not receive the dual screening process prior to prophylactic intravenous hydration. The current study aims to describe post-contrast outcomes of patients to whom the CVP screening method has been applied and to compare them to earlier outcomes of patients to whom the screening was not applied.
- Being tested
- CVP screening
- Keywords
- intravascular iodinated contrast administration, prophylactic intravenous hydration
- 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.
CVP screeningOther
An appropriate dual screening process including both renal and cardiac parameters to minimize the risks of post-contrast renal adverse outcomes and of prophylactic hydration in eGFR<30mL/min/1.73m2 patients.
What is being measured
The primary outcome is the main question the study is designed to answer.
complications of prophylactic intravenous hydration
serious complications of prophylactic intravenous hydration (heart failure, arrhythmia)
Measured: 14 days
complications of prophylactic intravenous hydration 2
deaths with primary cause heart failure (and no known other underlying cause) within 14 days post-contrast
Measured: 14 days
complications of prophylactic intravenous hydration 3
proportion of all deaths in prophylaxis subgroups with primary cause heart failure within 14 days
Measured: 14 days
Secondary outcomes (6)
incidence of post-contrast acute kidney injury
acute increase in serum creatinine within 5 days post-contrast
Measured: 6 days
incidences of 1-month post-contrast dialysis and mortality
incidences of dialysis and all-cause mortality within post-contrast
Measured: 35 days
post-contrast change in eGFR
change in eGFR from baseline post-contrast
Measured: 6 days
prophylaxis administered
percentage of patients receiving standard, adapted and no prophylactic intravenous hydration
Measured: 1 day
post-contrast AKI according to KDIGO definition
post-contrast AKI according to KDIGO definition
Measured: 6 days
ODDS ratios prophylaxis
where possible odds ratios for standard prophylaxis versus no prophylaxis and adapted prophylaxis versus no prophylaxis will be calculated for post-contrast acute kidney injury, 1-month dialysis and death
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start1 Dec 2018
- Primary completion6 Jan 2023
- Study completion6 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney Injury (Nontraumatic)Studies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 443 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04592406
- Sponsor's protocol ID
- NL.MUMC.AMACINGrp.4
- Acronym
- CVP
- Status last verified
- Jan 2023
- First submitted
- 7 Oct 2020
- Last updated
- 18 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Data on the Prevention of Complications of Prophylactic Intravenous Hydration in Patients With Estimated Glomerular Filtration Rate (eGFR) < 30 ml/Min/1.73m2 From the Maastricht UMC+ Contrast Voorbereidings Polikliniek
- ClinicalTrials.gov ID
- NCT04592406
- Acronym / sponsor ID
- CVP / NL.MUMC.AMACINGrp.4
- Keywords
- intravascular iodinated contrast administration, prophylactic intravenous hydration
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 443 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 6 Jan 2023 (actual)
- Study completion
- 6 Jan 2023 (actual)
- First posted
- 19 Oct 2020 (actual)
- 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.
At Maastricht University Medical Centre (Maastricht UMC+) a specialised unit was established where a dual screening process including both renal and cardiac parameters is used to minimize the risk of contrast-induced acute kidney injury as well as the risk of prophylactic hydration in eGFR<30mL/min/1.73m2 patients. Very little data exists on patients with eGFR <30mL/min/1.73m2 in this context. The current study aims to describe post-contrast outcomes of patients to whom this screening method has been applied.
Detailed description
A large retrospective observational study, including 4-years of elective procedures with intravascular iodinated contrast administration in eGFR<30mL/min/1.73m2 patients at Maastricht UMC+, found that prophylactic intravenous hydration might confer some benefit for renal function. For patients who had received prophylactic hydration, adjusted odds ratios for risk of post-contrast acute kidney injury, and 1-month eGFR decline and dialysis were all lower than 1. These results were not significant, but suggest that hydration may be protective. On the other hand, adjusted odds ratios for all-cause mortality within 1-month post-contrast were higher than 1, with point estimates indicating a trend toward higher risk of short-term mortality after prophylaxis as compared to no prophylaxis. Confounding by indication may be responsible for the observed increased risk of short-term mortality, but complications of the prophylaxis did contribute towards the risk. Amongst the 281 eGFR<30mL/min/1.73m2 prophylaxis patients studied, 18 (6.4%) serious complications occurred: 3 arrhythmias, and 15 heart failures including 5 deaths. Of all 21 deaths recorded for the prophylaxis patients, 24% (5/21) were considered to be related to intravenous fluids. An exploration of differences in baseline characteristics between patients with and without serious complications suggested that these can be avoided if cardiac function parameters are given extra and individual attention before deciding whether to administer prophylaxis to high-risk patients with eGFR<30mL/min/1.73m2. At Maastricht UMC+ a specialised unit (called the CVP) was established where a dual screening process including both renal and cardiac parameters is used to minimize the risk of contrast-induced acute kidney injury as well as the risk of prophylactic hydration in eGFR<30mL/min/1.73m2 patients. In order to enable real function follow-up, the CVP registers data on all patients with eGFR <30 receiving intravascular iodinated contrast material, including acute patients who did not receive the dual screening process prior to prophylactic intravenous hydration. The current study aims to describe post-contrast outcomes of patients to whom the CVP screening method has been applied and to compare them to earlier outcomes of patients to whom the screening was not applied.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with eGFR <30 mL/min/1.73m2 in absence of dialysis referred for a procedure with intravascular administration of iodinated contrast material at Maastricht UMC+
Key inclusion criteria (2 listed)
- eGFR <30 mL/min/1.73m2 in absence of dialysis
- referred for a procedure with intravascular administration of iodinated contrast material at Maastricht UMC+
Key exclusion criteria (3 listed)
- age <18 years
- dialysis or pre-dialysis
- emergency or intensive care status
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 |
|---|---|---|
| CVP screeningAn appropriate dual screening process including both renal and cardiac parameters to minimize the risks of post-contrast renal adverse outcomes and of prophylactic hydration in eGFR<30mL/min/1.73m2 patients. | Other | – |
Primary outcome
complications of prophylactic intravenous hydration
Time frame: 14 days
serious complications of prophylactic intravenous hydration (heart failure, arrhythmia)
complications of prophylactic intravenous hydration 2
Time frame: 14 days
deaths with primary cause heart failure (and no known other underlying cause) within 14 days post-contrast
complications of prophylactic intravenous hydration 3
Time frame: 14 days
proportion of all deaths in prophylaxis subgroups with primary cause heart failure within 14 days
6 secondary outcomes
incidence of post-contrast acute kidney injury
Time frame: 6 days
incidences of 1-month post-contrast dialysis and mortality
Time frame: 35 days
post-contrast change in eGFR
Time frame: 6 days
prophylaxis administered
Time frame: 1 day
post-contrast AKI according to KDIGO definition
Time frame: 6 days
ODDS ratios prophylaxis
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Kidney Injury (Nontraumatic) and Contrast-induced Nephropathy, run by Maastricht University Medical Center at 1 site in Netherlands.
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 2 inclusion and 3 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: finished, as of the sponsor's last update on 18 Jan 2023. 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 Netherlands. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
complications of prophylactic intravenous hydration (time frame: 14 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Jan 2023.