Acute Kidney InjuryNCT02894164
Evaluating the Role of Cystatin C and Creatinine as Markers of Renal Recovery in Critically Ill Patients After Acute Kidney Injury.
An observational study of Acute Kidney Injury and Chronic Kidney Disease, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
This is a cohort study in which patients who survive Acute Kidney Injury (AKI) during intensive care unit (ICU) admission are recalled at 3-6 months and renal function tests are performed. The purpose of the study is describe renal function in AKI survivors at follow-up. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Acute Kidney Injury, Chronic Kidney Disease, Acute Kidney Disease
- How many people
- 336 participants
- Where
- 1 siteSweden
- Study dates
- Jan 2008to Dec 2014
- How long will I take part?
- 2 Years
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted to the central intensive care unit at Karolinska University hospital, who suffered from AKI during the period September 2008 until May 2011.
Who may be able to join
- Adults treated on Intensive care with AKI (RIFLE criteria)
- Survival 3 months after discharge.
- Admission during September 2008-May 2011
Who cannot join
- Under 18 years
- Unable to give consent.
- Admission during a time when study staff not working.
- Death before 3 month follow-up
- No Swedish personal identification number
Trial locations and contacts
1 site in 1 country.
About this study
This is a cohort study in which patients who survive Acute Kidney Injury (AKI) during intensive care unit (ICU) admission are recalled at 3-6 months and renal function tests are performed.
The purpose of the study is describe renal function in AKI survivors at follow-up.
Additional aims are to determine how well admission values of renal function markers perform as predictors of renal function at follow-up and whether estimates of renal function at follow-up differ depending on which renal function marker is used.
Read the detailed description
Type of study: Cohort study with prospectively collected clinical data cross-matched with local \& national databases.
Source population: Patients suffering from AKI on a mixed intensive care unit, at the Karolinska University Hospital, Solna.
Setting: Single centre, Central Intensive Care unit Karolinska University hospital, Solna, Stockholm from September 2008 and May 2011.
Exposure: AKI on ICU and grade of AKI according to the RIFLE criteria Intervention: none
Outcome: Renal function 3 months after ICU discharge according to creatinine and Cystatin C measurements.
Parameters: Co-morbidities, ICU diagnoses, disease severity score, daily physiological and laboratory parameters, medications administered, interventions RRT (Renal replacement therapy), mechanical intervention, inotropes, surgery.
Data is crossmatched with national registries including the Swedish cause of death register (to obtain dates of death), the Swedish renal register (to obtain details of patients receiving chronic dialysis and with pre-existing Chronic Kidney Disease (CKD) diagnoses. Data is also cross matched with a large local ICU register (Clinisoft) to obtain physiological parameters\& intervention details. Clinisoft is also used to obtain risk of death for all ICU patients and all AKI patients (from the source population). Ethical approval has been granted by Stockholm Regional ethical review body (2008-408-32 2008/443-31/1-3, 2010/1780-31-2, 2011-408-32 and 2016-1801-32).
Aims:
- Describe the incidence of renal dysfunction in terms of Glomerular filtration rate (GFR) under 60ml/min/173m² at 3-6 months follow-up after AKI. According to serum Cystatin C and Creatinine values.
- Describe the incidence of Acute Kidney Disease (AKD) at 3 month follow-up.
- Produce a predictive model using comorbidities and admission data to CKD (Chronic Kidney Disease) and AKD 3-6 after AKI in intensive care patients.
- Examine how estimated GFR using creatinine and Cystatin C differ from measured Iohexol GFR at 6 month follow-up.
- Being tested
- No intervention
- Keywords
- Cystatin C, Creatinine, Glomerular Filtration Rate
- Medical subject headings
- Acute Kidney Injury, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Renal function
Renal function as defined by estimated glomerular filtration rate (eGFR)using seri Creatinine and Cystatin C at follow-up
Measured: 3-9 months
Secondary outcomes (1)
Mortality
Death as recorded in the swedish national death register.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2016 (estimated)
- Study startJan 2008
- Primary completionDec 2011
- Study completionDec 2014
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 Karolinska InstitutetThe 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
- 336 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Claire Rimes-Stigare, Karolinska Institutet
- Investigators
- Max Bell, PhD, Study director, Karolinska InstitutetJohan Mårtensson, PhD, Principal investigator, Karolinska InstitutetClaes-Roland Martling, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02894164
- Sponsor's protocol ID
- CysCr1
- Status last verified
- Aug 2017
- First submitted
- 5 Sep 2016
- Last updated
- 23 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Data is anonymised and data regarding individuals will not be published.
Publications
Bellomo R, Ronco C, Kellum JA, Mehta RL, Palevsky P; Acute Dialysis Quality Initiative workgroup. Acute renal failure - definition, outcome measures, animal models, fluid therapy and information technology needs: the Second International Consensus Conference of the Acute Dialysis Quality Initiative (ADQI) Group. Crit Care. 2004 Aug;8(4):R204-12. doi: 10.1186/cc2872. Epub 2004 May 24.
PubMed 15312219
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Role of Cystatin C and Creatinine as Markers of Renal Recovery in Critically Ill Patients After Acute Kidney Injury.
- ClinicalTrials.gov ID
- NCT02894164
- Acronym / sponsor ID
- CysCr1
- Keywords
- Cystatin C, Creatinine, Glomerular Filtration Rate
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 336 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 9 Sep 2016 (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.
This is a cohort study in which patients who survive Acute Kidney Injury (AKI) during intensive care unit (ICU) admission are recalled at 3-6 months and renal function tests are performed.
The purpose of the study is describe renal function in AKI survivors at follow-up.
Additional aims are to determine how well admission values of renal function markers perform as predictors of renal function at follow-up and whether estimates of renal function at follow-up differ depending on which renal function marker is used.
Detailed description
Type of study: Cohort study with prospectively collected clinical data cross-matched with local \& national databases.
Source population: Patients suffering from AKI on a mixed intensive care unit, at the Karolinska University Hospital, Solna.
Setting: Single centre, Central Intensive Care unit Karolinska University hospital, Solna, Stockholm from September 2008 and May 2011.
Exposure: AKI on ICU and grade of AKI according to the RIFLE criteria Intervention: none
Outcome: Renal function 3 months after ICU discharge according to creatinine and Cystatin C measurements.
Parameters: Co-morbidities, ICU diagnoses, disease severity score, daily physiological and laboratory parameters, medications administered, interventions RRT (Renal replacement therapy), mechanical intervention, inotropes, surgery.
Data is crossmatched with national registries including the Swedish cause of death register (to obtain dates of death), the Swedish renal register (to obtain details of patients receiving chronic dialysis and with pre-existing Chronic Kidney Disease (CKD) diagnoses. Data is also cross matched with a large local ICU register (Clinisoft) to obtain physiological parameters\& intervention details. Clinisoft is also used to obtain risk of death for all ICU patients and all AKI patients (from the source population). Ethical approval has been granted by Stockholm Regional ethical review body (2008-408-32 2008/443-31/1-3, 2010/1780-31-2, 2011-408-32 and 2016-1801-32).
Aims:
- Describe the incidence of renal dysfunction in terms of Glomerular filtration rate (GFR) under 60ml/min/173m² at 3-6 months follow-up after AKI. According to serum Cystatin C and Creatinine values.
- Describe the incidence of Acute Kidney Disease (AKD) at 3 month follow-up.
- Produce a predictive model using comorbidities and admission data to CKD (Chronic Kidney Disease) and AKD 3-6 after AKI in intensive care patients.
- Examine how estimated GFR using creatinine and Cystatin C differ from measured Iohexol GFR at 6 month follow-up.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to the central intensive care unit at Karolinska University hospital, who suffered from AKI during the period September 2008 until May 2011.
Key inclusion criteria (3 listed)
- Adults treated on Intensive care with AKI (RIFLE criteria)
- Survival 3 months after discharge.
- Admission during September 2008-May 2011
Key exclusion criteria (5 listed)
- Under 18 years
- Unable to give consent.
- Admission during a time when study staff not working.
- Death before 3 month follow-up
- No Swedish personal identification number
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 |
|---|---|---|
| No intervention | Other | – |
Primary outcome
Renal function
Time frame: 3-9 months
Renal function as defined by estimated glomerular filtration rate (eGFR)using seri Creatinine and Cystatin C at follow-up
1 secondary outcome
Mortality
Time frame: 2 years
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 23 Aug 2017.
- Background: PubMed 15312219Bellomo R, Ronco C, Kellum JA, Mehta RL, Palevsky P; Acute Dialysis Quality Initiative workgroup. Acute renal failure - definition, outcome measures, animal models, fluid therapy and information technology needs: the Second International Consensus Conference of the Acute Dialysis Quality Initiative (ADQI) Group. Crit Care. 2004 Aug;8(4):R204-12. doi: 10.1186/cc2872. Epub 2004 May 24.
- Individual participant dataSharing planned: No. Data is anonymised and data regarding individuals will not be published.
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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.
Max Bell, PhD study director
Karolinska Institutet
Johan Mårtensson, PhD principal investigator
Karolinska Institutet
Claes-Roland Martling, PhD principal investigator
Karolinska Institutet
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 and Chronic Kidney Disease, run by Karolinska Institutet 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 3 inclusion and 5 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 23 Aug 2017. 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?
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?
Renal function (time frame: 3-9 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 NCT02894164, 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 23 Aug 2017.