Critical IllnessNCT05385094
Consistency Between Measures of Renal Function in ICU Patients
An observational study of Critical Illness, run by Karolinska University Hospital at 1 site in Sweden.
Trial summary
This study aim to compare different measures of renal function (glomerular filtration rate) in ICU patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness
- What is being tested?
- S Creatinine concentration, Serum Cystatin C concentration and Urinary Creatinine Clearance
- How many people
- 5,000 participants
- Where
- 1 siteSweden
- Study dates
- 1 Jan 2006to 31 Dec 2024
- 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: General ICU patients
Who may be able to join
- ICU patients with at least one measurement of urinary creatinine clearance
Who cannot join
- Renal replacement therapy initiated before the measurement of creatinine clerance
Trial locations and contacts
1 site in 1 country.
About this study
This study aim to compare different measures of renal function (glomerular filtration rate) in ICU patients.
Read the detailed description
The study uses a large dataset of prospectively collected data according to clinical routines.
- Conditions
- Critical Illness
- Being tested
- S Creatinine concentration, Serum Cystatin C concentration, Urinary Creatinine Clearance
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S Creatinine concentrationDiagnostic test
Serum Cystatin C concentrationDiagnostic test
Urinary Creatinine ClearanceDiagnostic test
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlations between estimates of renal function
Measured: 7 days
Correlations between changes in estimates of renal function
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2022
- Study start1 Jan 2006
- Primary completion31 Dec 2017
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- More trials run by Karolinska University HospitalThe 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
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Johan Petersson, Karolinska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05385094
- Sponsor's protocol ID
- EPN 2017/806-31 Renal Function
- Status last verified
- May 2022
- First submitted
- 12 Dec 2021
- Last updated
- 23 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: No plan.
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Consistency Between Measures of Renal Function in ICU Patients
- ClinicalTrials.gov ID
- NCT05385094
- Acronym / sponsor ID
- EPN 2017/806-31 Renal Function
- Conditions
- Critical Illness
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Karolinska University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2006 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 23 May 2022 (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 aim to compare different measures of renal function (glomerular filtration rate) in ICU patients.
Detailed description
The study uses a large dataset of prospectively collected data according to clinical routines.
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
- General ICU patients
Key inclusion criteria (1 listed)
- ICU patients with at least one measurement of urinary creatinine clearance
Key exclusion criteria (1 listed)
- Renal replacement therapy initiated before the measurement of creatinine clerance
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 |
|---|---|---|
| S Creatinine concentration | Diagnostic test | – |
| Serum Cystatin C concentration | Diagnostic test | – |
| Urinary Creatinine Clearance | Diagnostic test | – |
Primary outcome
Correlations between estimates of renal function
Time frame: 7 days
Correlations between changes in estimates of renal function
Time frame: 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2022.
- Individual participant dataSharing planned: Undecided. No plan.
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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 Critical Illness, run by Karolinska University Hospital 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 1 inclusion and 1 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 23 May 2022. 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?
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?
Correlations between estimates of renal function (time frame: 7 days). The study lists 2 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 23 May 2022.