Acute Kidney Injury Following Administration of Contrast MediaCOINCIDESNCT06171958
Incidence of Acute Kidney Injury After Administration of Iodine Contrast Media in Patients With Reduced Renal Function
An observational study of Acute Kidney Injury Following Administration of Contrast Media, run by Uppsala University at 1 site in Sweden.
Trial summary
This study is examining if injection of iodine contrast media increases the risk of acute kidney injury in patients with severely reduced renal function. All patients who have a medical need for a computerized tomography, either with or without iodine contrast media, and has a renal function of less than estimated… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury Following Administration of Contrast Media
- What is being tested?
- Iodine-containing Contrast Media
- How many people
- 400 participants
- Where
- 1 siteSweden
- Study dates
- 24 Jan 2024to 31 Dec 2025
- 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
- Adult, Older adult
Study population: Patients referred for a CT at Uppsala University Hospital which is a tertiary level hospital that also handles most emergency cases in Uppsala county, Sweden.
Who may be able to join
- eGFR <30 mL/min/1.73m2, calculated with the revised Lund-Malmö formula and plasma creatinine.
- Medical need of either an ICM-enhanced or unenhanced CT
Who cannot join
- <18 years of age
- Ongoing renal replacement therapy
- Ongoing treatment with nephrotoxic drugs. Drugs classified as nephrotoxic are acyclovir, aminoglycosides, ciclosporins, cisplatin, methotrexate, non-steroidal anti-inflammatory drugs (except low-dose aspirin) and vancomycin administered intravenously.
- Known allergy to ICM who and have not received prophylactic treatment (if patient belongs to ICM arm)
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Uppsala University
Uppsala, 751 85
Per G Liss, PhD, MD, +46722223476, per.liss@uu.se
About this study
Official title: Cohort Study of Intravenous Contrast-media Influence on Decreased Renal Function
This study is examining if injection of iodine contrast media increases the risk of acute kidney injury in patients with severely reduced renal function. All patients who have a medical need for a computerized tomography, either with or without iodine contrast media, and has a renal function of less than estimated glomerular filtration rate (eGFR) 30 will be recruited. Blood and urine samples will be collected at baseline, three and 21 days after the computerized tomography. Additionally, we will examine if the decision to use iodine contrast media or not was easy or difficult if the use of iodine contrast media potentially changed the patient care and if it might have been lifesaving.
Read the detailed description
This is a single centre prospective cohort study performed at a tertiary level, university hospital in Sweden.
Background data included age, sex, height, and weight. Body surface area (BSA) is calculated with DuBois formula. Clinical history consists of chronic heart failure (CHF), chronic kidney disease (CKD), diabetes mellitus (DM), hypertension and liver failure. Details regarding the CT such as examined body part, clinical question on CT referral, if iodine contrast media (ICM) was used and, if so, which dose, type and concentration is going to be recorded.
Blood and urine samples will be collected three times prospectively and, if available, previously recorded plasma creatinine values will be recorded once as well. The retrospective value is recorded at least seven days before CT. The prospective values are going to be recorded within 24 hours before CT, 72 hours after CT and 21 days after CT. The following biomarkers are analysed in plasma: bicarbonate, creatinine, cystatin C and endostatin. The following biomarkers are analysed in urine: angiotensinogen (AGT), creatinine, cystatin C, endostatin, kidney injury molecule-1 (KIM-1), neutrophile gelatinase associated lipase (NGAL) and tissue inhibitor of metalloproteinase-2 (TIMP-2). The revised Lund-Malmö formula is used to calculate eGFR based on creatinine. The Caucasian and Asian Paediatric and Adult subjects (CAPA) formula is used to calculate eGFR from Cystatin C.
Five yes or no-questions are going to be answered, two before the exam and three after. The questions answered before the exam will be answered by the radiologist who decided upon the exam protocol, and they are investigating if the decision to use ICM or not was easy to make. The questions after the exam are going to be answered by two senior radiologists independent of each other and they relate to if ICM helped in the discovery of clinically relevant information and if that information/condition was life-threatening. The third question will be answered by going through the patient's discharge summary and is looking at the main diagnosis and if that diagnosis would have been easier to discover with the use of ICM. Since no clear definition of life-threatening exists all diagnoses that were considered life-threatening will be stated in the manuscript. The data will be recorded in the electronic data capture REDCap.
Sample size has been calculated based on an incidence of 14%, a margin of error of 5% and a 95% confidence interval. If there will be to much missing data to run a complete observation analysis, and especially if it is unbalanced between ICM and no ICM an imputation will be performed.
Association will be evaluated with logistic regression. Test of difference among groups will be performed with chi-2 test for categorical variables and the Kruskal-Wallis test for continuous variables. If to many data points are missing and especially if it is unbalanced between groups imputation will be performed. Data will be presented as median and interquartile range or as frequency in percent where suitable. A significance level of 0.05 will be used.
- Being tested
- Iodine-containing Contrast Media
- Keywords
- cohort study, incidence study, acute kidney injury, contrast media, tomography, x-ray computed
- 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.
Iodine-containing Contrast MediaDrug
Patients will receive or not receive ICM depending on their medical need.
| Study group | Role | What they receive |
|---|---|---|
| ICM | Patients receiving ICM at CT Receives: Drug: Iodine-containing Contrast Media | |
| No ICM | Patients not receiving ICM at CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of post-contrast acute kidney injury (PC-AKI)
The primary outcome, PC-AKI, is defined and staged according to the creatinine-based criteria from Kidney Disease Improve Global Outcome (KDIGO) [5]. If any of these criteria are fulfilled 72 hours after ICM administration the patient had PC-AKI. The urine output criterion was not used in this study. PC-AKI should be read as post-CT AKI in patients not receiving ICM.
Measured: This outcome is measured 72 hours after CT.
Incidence of long-term decline in renal function
Any remaining increase in creatinine compared to baseline.
Measured: This outcome is measured 21 days after CT.
Incidence of long-term decline in renal function
Any remaining increase in cystatin C compared to baseline.
Measured: This outcome is measured 21 days after CT.
Secondary outcomes (2)
Incidence of mortality
Mortality will be recorded during the follow-up period.
Measured: 21 days
Incidence of need for renal replacement therapy
A need for any form of renal replacement during the follow-up period.
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2023
- Study start24 Jan 2024
- Primary completion31 Jul 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Acute Kidney Injury Following Administration of Contrast MediaStudies of the same condition, open and under way.
- More trials run by Uppsala UniversityThe 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
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06171958
- Sponsor's protocol ID
- COINCIDES
- Acronym
- COINCIDES
- Status last verified
- May 2024
- First submitted
- 16 Nov 2023
- Last updated
- 20 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The datasets generated and/or analysed during the current study are not publicly available due national and European Union regulations regarding patient related data but are available from the corresponding author on reasonable request.
Publications
Du BOIS D, Du BOIS EF. CLINICAL CALORIMETRY: TENTH PAPER A FORMULA TO ESTIMATE THE APPROXIMATE SURFACE AREA IF HEIGHT AND WEIGHT BE KNOWN. Archives of Internal Medicine. 1916;XVII(6_2):863-71.
Bjork J, Grubb A, Sterner G, Nyman U. Revised equations for estimating glomerular filtration rate based on the Lund-Malmo Study cohort. Scand J Clin Lab Invest. 2011 May;71(3):232-9. doi: 10.3109/00365513.2011.557086. Epub 2011 Mar 10.
PubMed 21391777Grubb A, Horio M, Hansson LO, Bjork J, Nyman U, Flodin M, Larsson A, Bokenkamp A, Yasuda Y, Blufpand H, Lindstrom V, Zegers I, Althaus H, Blirup-Jensen S, Itoh Y, Sjostrom P, Nordin G, Christensson A, Klima H, Sunde K, Hjort-Christensen P, Armbruster D, Ferrero C. Generation of a new cystatin C-based estimating equation for glomerular filtration rate by use of 7 assays standardized to the international calibrator. Clin Chem. 2014 Jul;60(7):974-86. doi: 10.1373/clinchem.2013.220707. Epub 2014 May 14.
PubMed 24829272McDonald JS, McDonald RJ, Carter RE, Katzberg RW, Kallmes DF, Williamson EE. Risk of intravenous contrast material-mediated acute kidney injury: a propensity score-matched study stratified by baseline-estimated glomerular filtration rate. Radiology. 2014 Apr;271(1):65-73. doi: 10.1148/radiol.13130775. Epub 2014 Jan 16.
PubMed 24475854KDIGO. KDIGO Clinical Practice Guideline for Acute Kidney Injury. Kidney International, Supplements. 2012;2(1).
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cohort Study of Intravenous Contrast-media Influence on Decreased Renal Function
- ClinicalTrials.gov ID
- NCT06171958
- Acronym / sponsor ID
- COINCIDES / COINCIDES
- Keywords
- cohort study, incidence study, acute kidney injury, contrast media, tomography, x-ray computed
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Study start
- 24 Jan 2024 (actual)
- Primary completion
- 31 Jul 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 15 Dec 2023 (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.
This study is examining if injection of iodine contrast media increases the risk of acute kidney injury in patients with severely reduced renal function. All patients who have a medical need for a computerized tomography, either with or without iodine contrast media, and has a renal function of less than estimated glomerular filtration rate (eGFR) 30 will be recruited. Blood and urine samples will be collected at baseline, three and 21 days after the computerized tomography. Additionally, we will examine if the decision to use iodine contrast media or not was easy or difficult if the use of iodine contrast media potentially changed the patient care and if it might have been lifesaving.
Detailed description
This is a single centre prospective cohort study performed at a tertiary level, university hospital in Sweden.
Background data included age, sex, height, and weight. Body surface area (BSA) is calculated with DuBois formula. Clinical history consists of chronic heart failure (CHF), chronic kidney disease (CKD), diabetes mellitus (DM), hypertension and liver failure. Details regarding the CT such as examined body part, clinical question on CT referral, if iodine contrast media (ICM) was used and, if so, which dose, type and concentration is going to be recorded.
Blood and urine samples will be collected three times prospectively and, if available, previously recorded plasma creatinine values will be recorded once as well. The retrospective value is recorded at least seven days before CT. The prospective values are going to be recorded within 24 hours before CT, 72 hours after CT and 21 days after CT. The following biomarkers are analysed in plasma: bicarbonate, creatinine, cystatin C and endostatin. The following biomarkers are analysed in urine: angiotensinogen (AGT), creatinine, cystatin C, endostatin, kidney injury molecule-1 (KIM-1), neutrophile gelatinase associated lipase (NGAL) and tissue inhibitor of metalloproteinase-2 (TIMP-2). The revised Lund-Malmö formula is used to calculate eGFR based on creatinine. The Caucasian and Asian Paediatric and Adult subjects (CAPA) formula is used to calculate eGFR from Cystatin C.
Five yes or no-questions are going to be answered, two before the exam and three after. The questions answered before the exam will be answered by the radiologist who decided upon the exam protocol, and they are investigating if the decision to use ICM or not was easy to make. The questions after the exam are going to be answered by two senior radiologists independent of each other and they relate to if ICM helped in the discovery of clinically relevant information and if that information/condition was life-threatening. The third question will be answered by going through the patient's discharge summary and is looking at the main diagnosis and if that diagnosis would have been easier to discover with the use of ICM. Since no clear definition of life-threatening exists all diagnoses that were considered life-threatening will be stated in the manuscript. The data will be recorded in the electronic data capture REDCap.
Sample size has been calculated based on an incidence of 14%, a margin of error of 5% and a 95% confidence interval. If there will be to much missing data to run a complete observation analysis, and especially if it is unbalanced between ICM and no ICM an imputation will be performed.
Association will be evaluated with logistic regression. Test of difference among groups will be performed with chi-2 test for categorical variables and the Kruskal-Wallis test for continuous variables. If to many data points are missing and especially if it is unbalanced between groups imputation will be performed. Data will be presented as median and interquartile range or as frequency in percent where suitable. A significance level of 0.05 will be used.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ICM | – | Drug: Iodine-containing Contrast MediaPatients receiving ICM at CT |
| No ICM | – | –Patients not receiving ICM at CT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients referred for a CT at Uppsala University Hospital which is a tertiary level hospital that also handles most emergency cases in Uppsala county, Sweden.
Key inclusion criteria (2 listed)
- eGFR <30 mL/min/1.73m2, calculated with the revised Lund-Malmö formula and plasma creatinine.
- Medical need of either an ICM-enhanced or unenhanced CT
Key exclusion criteria (4 listed)
- <18 years of age
- Ongoing renal replacement therapy
- Ongoing treatment with nephrotoxic drugs. Drugs classified as nephrotoxic are acyclovir, aminoglycosides, ciclosporins, cisplatin, methotrexate, non-steroidal anti-inflammatory drugs (except low-dose aspirin) and vancomycin administered intravenously.
- Known allergy to ICM who and have not received prophylactic treatment (if patient belongs to ICM arm)
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 |
|---|---|---|
| Iodine-containing Contrast MediaPatients will receive or not receive ICM depending on their medical need. | Drug | ICM |
Primary outcome
Incidence of post-contrast acute kidney injury (PC-AKI)
Time frame: This outcome is measured 72 hours after CT.
The primary outcome, PC-AKI, is defined and staged according to the creatinine-based criteria from Kidney Disease Improve Global Outcome (KDIGO) [5]. If any of these criteria are fulfilled 72 hours after ICM administration the patient had PC-AKI. The urine output criterion was not used in this study. PC-AKI should be read as post-CT AKI in patients not receiving ICM.
Incidence of long-term decline in renal function
Time frame: This outcome is measured 21 days after CT.
Any remaining increase in creatinine compared to baseline.
Incidence of long-term decline in renal function
Time frame: This outcome is measured 21 days after CT.
Any remaining increase in cystatin C compared to baseline.
2 secondary outcomes
Incidence of mortality
Time frame: 21 days
Incidence of need for renal replacement therapy
Time frame: 21 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2024.
- BackgroundDu BOIS D, Du BOIS EF. CLINICAL CALORIMETRY: TENTH PAPER A FORMULA TO ESTIMATE THE APPROXIMATE SURFACE AREA IF HEIGHT AND WEIGHT BE KNOWN. Archives of Internal Medicine. 1916;XVII(6_2):863-71.
- Background: PubMed 21391777Bjork J, Grubb A, Sterner G, Nyman U. Revised equations for estimating glomerular filtration rate based on the Lund-Malmo Study cohort. Scand J Clin Lab Invest. 2011 May;71(3):232-9. doi: 10.3109/00365513.2011.557086. Epub 2011 Mar 10.
- Background: PubMed 24829272Grubb A, Horio M, Hansson LO, Bjork J, Nyman U, Flodin M, Larsson A, Bokenkamp A, Yasuda Y, Blufpand H, Lindstrom V, Zegers I, Althaus H, Blirup-Jensen S, Itoh Y, Sjostrom P, Nordin G, Christensson A, Klima H, Sunde K, Hjort-Christensen P, Armbruster D, Ferrero C. Generation of a new cystatin C-based estimating equation for glomerular filtration rate by use of 7 assays standardized to the international calibrator. Clin Chem. 2014 Jul;60(7):974-86. doi: 10.1373/clinchem.2013.220707. Epub 2014 May 14.
- Background: PubMed 24475854McDonald JS, McDonald RJ, Carter RE, Katzberg RW, Kallmes DF, Williamson EE. Risk of intravenous contrast material-mediated acute kidney injury: a propensity score-matched study stratified by baseline-estimated glomerular filtration rate. Radiology. 2014 Apr;271(1):65-73. doi: 10.1148/radiol.13130775. Epub 2014 Jan 16.
- BackgroundKDIGO. KDIGO Clinical Practice Guideline for Acute Kidney Injury. Kidney International, Supplements. 2012;2(1).
- Individual participant dataSharing planned: No. The datasets generated and/or analysed during the current study are not publicly available due national and European Union regulations regarding patient related data but are available from the corresponding author on reasonable request.
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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.
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 Following Administration of Contrast Media, run by Uppsala University at 1 site in Sweden.
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 4 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: status not confirmed, as of the sponsor's last update on 20 May 2024. 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 Sweden. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Felix B Berglund, MD (+46703387606, felix.berglund@uu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of post-contrast acute kidney injury (PC-AKI) (time frame: This outcome is measured 72 hours after CT.). 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?
On the ClinicalTrials.gov record for NCT06171958, which also lists 5 linked publications.
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 20 May 2024.