Acute Kidney InjuryNCT02424747
Long-term Survival and Renal Outcomes in Critically Ill Patients After Acute Kidney Injury: Swedish Multi-centre Cohort Study
An observational study of Acute Kidney Injury, run by Karolinska Institutet.
Trial summary
The study evaluates how outcome varies among critically ill patients with and without acute kidney injury. Data from the Swedish Intensive care register and other Swedish national registers is used to compare how survival and post discharge renal function differ between critically ill patients with and without acute… 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?
- Acute Kidney Injury
- How many people
- 103,000 participants
- Where
- No sites listed yet
- Study dates
- Jan 2005to Dec 2011
- How long will I take part?
- 5 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population was provided by the Swedish Intensive Care register and included patients receiving intensive care treatment between January 2005 and January 2011
Who may be able to join
- All first admissions of adult patients registered on the Swedish Intensive Care Register between January 1st 2005 and January 1st 2011.
Who cannot join
- Patients under 18. Subjects with incomplete records. Patients previously diagnosed with Chronic Kidney Disease or End Stage Renal disease.
- -
About this study
Official title: Long Term Survival and Renal Outcomes in Critically Ill Patients After Acute Kidney Injury: Swedish Multi-centre Cohort Study
The study evaluates how outcome varies among critically ill patients with and without acute kidney injury. Data from the Swedish Intensive care register and other Swedish national registers is used to compare how survival and post discharge renal function differ between critically ill patients with and without acute kidney injury.
Read the detailed description
Background: Acute kidney injury is common amongst intensive care patients and is associated with extremely high mortality and morbidity in terms of increased risk of developing Chronic Kidney Disease (CKD) and End Stage Renal Disease (ESRD). Patients with CKD are at increased risk of cardiovascular, cerebro-vascular disease and long term increased risk of death. Those patients who progress to ESRD have a 20% mortality risk per year in Sweden. Outcome after acute kidney injury in the Swedish critical care population has never previously been described.
Method: This cohort study uses Swedish national healthcare registers to investigate the epidemiology of acute kidney injury. The Swedish Intensive Care Register (SIR) provides the population base, with data extraction between 2005 and 2011. The information obtained is cross-matched by the Swedish board for health and welfare (Social Styrelsen) with other national registries. All data are returned anonymized and individual patients can not be identified in any way. Additionally analysis is performed on a group and not on an individual basis. The key to this data is held by Swedish board for health and welfare. The other national registries include the Swedish Cause of Death Register (Dödsregister), the Swedish renal register (Svensknjurregistret) and the in and out-patients registers (Öppen- slutenvårdsregister) these are used to obtain data on all cause mortality, co-morbidities, Pre and Post ICU CKD and ESRD. Epidemiological methods are used to analyse the data.
Investigators aim to describe outcome in terms of long-term mortality (up to five years) and renal morbidity (incidence of CKD and ESRD) in critically ill patients with and without de novo AKI in Sweden.
- Conditions
- Acute Kidney Injury
- Being tested
- Acute Kidney Injury
- 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.
Acute Kidney InjuryOther
We will identify and observe "exposure" to Acute Kidney Injury during Intensive Care admission.
| Study group | Role | What they receive |
|---|---|---|
| De Novo Acute Kidney Injury | Patients who developed Acute Kidney Injury during intensive care admission and not previously diagnosed with chronic kidney disease or end stage renal disease. Receives: Other: Acute Kidney Injury | |
| No Acute Kidney Injury. | Intensive care patients not diagnosed with acute kidney Injury during admission and not previously diagnosed with Chronic Kidney Disease or End Stage Renal Disease. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Measured: 5 year
Secondary outcomes (2)
Incidence of Chronic Kidney Disease
Measured: 5 years
Incidence of End Stage Renal Failure
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2015 (estimated)
- Study startJan 2005
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)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
- 103,000 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Region Stockholm, Baxter Healthcare Corporation
- Responsible party
- Principal investigator, Claire Rimes-Stigare, Karolinska Institutet
- Investigators
- Claire Stigare, MD, Principal investigator, karolinska University Hospital, Karolinska Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02424747
- Sponsor's protocol ID
- Karolinska Institutet SIR
- Status last verified
- Apr 2015
- First submitted
- 20 Apr 2015
- Last updated
- 24 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Goldstein SL, Jaber BL, Faubel S, Chawla LS; Acute Kidney Injury Advisory Group of American Society of Nephrology. AKI transition of care: a potential opportunity to detect and prevent CKD. Clin J Am Soc Nephrol. 2013 Mar;8(3):476-83. doi: 10.2215/CJN.12101112.
PubMed 23471414Bellomo R. The epidemiology of acute renal failure: 1975 versus 2005. Curr Opin Crit Care. 2006 Dec;12(6):557-60. doi: 10.1097/01.ccx.0000247443.86628.68.
PubMed 17077686Rimes-Stigare C, Awad A, Martensson J, Martling CR, Bell M. Long-term outcome after acute renal replacement therapy: a narrative review. Acta Anaesthesiol Scand. 2012 Feb;56(2):138-46. doi: 10.1111/j.1399-6576.2011.02567.x. Epub 2011 Oct 19.
PubMed 22092145Go AS, Chertow GM, Fan D, McCulloch CE, Hsu CY. Chronic kidney disease and the risks of death, cardiovascular events, and hospitalization. N Engl J Med. 2004 Sep 23;351(13):1296-305. doi: 10.1056/NEJMoa041031.
PubMed 15385656Bellomo R, Kellum JA, Ronco C. Acute kidney injury. Lancet. 2012 Aug 25;380(9843):756-66. doi: 10.1016/S0140-6736(11)61454-2. Epub 2012 May 21.
PubMed 22617274Emilsson L, Lindahl B, Koster M, Lambe M, Ludvigsson JF. Review of 103 Swedish Healthcare Quality Registries. J Intern Med. 2015 Jan;277(1):94-136. doi: 10.1111/joim.12303. Epub 2014 Sep 27.
PubMed 25174800Adami HO, Hernan MA. Learning how to improve healthcare delivery: the Swedish Quality Registers. J Intern Med. 2015 Jan;277(1):87-9. doi: 10.1111/joim.12315. Epub 2014 Nov 24. No abstract available.
PubMed 25270255Rimes-Stigare C, Frumento P, Bottai M, Martensson J, Martling CR, Bell M. Long-term mortality and risk factors for development of end-stage renal disease in critically ill patients with and without chronic kidney disease. Crit Care. 2015 Nov 3;19:383. doi: 10.1186/s13054-015-1101-8.
PubMed 26526622
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Survival and Renal Outcomes in Critically Ill Patients After Acute Kidney Injury: Swedish Multi-centre Cohort Study
- ClinicalTrials.gov ID
- NCT02424747
- Acronym / sponsor ID
- Karolinska Institutet SIR
- Conditions
- Acute Kidney Injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 103,000 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Region Stockholm, Baxter Healthcare Corporation
- Study start
- Jan 2005
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 23 Apr 2015 (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 study evaluates how outcome varies among critically ill patients with and without acute kidney injury. Data from the Swedish Intensive care register and other Swedish national registers is used to compare how survival and post discharge renal function differ between critically ill patients with and without acute kidney injury.
Detailed description
Background: Acute kidney injury is common amongst intensive care patients and is associated with extremely high mortality and morbidity in terms of increased risk of developing Chronic Kidney Disease (CKD) and End Stage Renal Disease (ESRD). Patients with CKD are at increased risk of cardiovascular, cerebro-vascular disease and long term increased risk of death. Those patients who progress to ESRD have a 20% mortality risk per year in Sweden. Outcome after acute kidney injury in the Swedish critical care population has never previously been described.
Method: This cohort study uses Swedish national healthcare registers to investigate the epidemiology of acute kidney injury. The Swedish Intensive Care Register (SIR) provides the population base, with data extraction between 2005 and 2011. The information obtained is cross-matched by the Swedish board for health and welfare (Social Styrelsen) with other national registries. All data are returned anonymized and individual patients can not be identified in any way. Additionally analysis is performed on a group and not on an individual basis. The key to this data is held by Swedish board for health and welfare. The other national registries include the Swedish Cause of Death Register (Dödsregister), the Swedish renal register (Svensknjurregistret) and the in and out-patients registers (Öppen- slutenvårdsregister) these are used to obtain data on all cause mortality, co-morbidities, Pre and Post ICU CKD and ESRD. Epidemiological methods are used to analyse the data.
Investigators aim to describe outcome in terms of long-term mortality (up to five years) and renal morbidity (incidence of CKD and ESRD) in critically ill patients with and without de novo AKI in Sweden.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| De Novo Acute Kidney Injury | – | Other: Acute Kidney InjuryPatients who developed Acute Kidney Injury during intensive care admission and not previously diagnosed with chronic kidney disease or end stage renal disease. |
| No Acute Kidney Injury. | – | –Intensive care patients not diagnosed with acute kidney Injury during admission and not previously diagnosed with Chronic Kidney Disease or End Stage Renal Disease. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population was provided by the Swedish Intensive Care register and included patients receiving intensive care treatment between January 2005 and January 2011
Key inclusion criteria (1 listed)
- All first admissions of adult patients registered on the Swedish Intensive Care Register between January 1st 2005 and January 1st 2011.
Key exclusion criteria (2 listed)
- Patients under 18. Subjects with incomplete records. Patients previously diagnosed with Chronic Kidney Disease or End Stage Renal disease.
- -
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 |
|---|---|---|
| Acute Kidney InjuryWe will identify and observe "exposure" to Acute Kidney Injury during Intensive Care admission. | Other | De Novo Acute Kidney Injury |
Primary outcome
Mortality
Time frame: 5 year
2 secondary outcomes
Incidence of Chronic Kidney Disease
Time frame: 5 years
Incidence of End Stage Renal Failure
Time frame: 5 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 24 Apr 2015.
- Background: PubMed 23471414Goldstein SL, Jaber BL, Faubel S, Chawla LS; Acute Kidney Injury Advisory Group of American Society of Nephrology. AKI transition of care: a potential opportunity to detect and prevent CKD. Clin J Am Soc Nephrol. 2013 Mar;8(3):476-83. doi: 10.2215/CJN.12101112.
- Background: PubMed 17077686Bellomo R. The epidemiology of acute renal failure: 1975 versus 2005. Curr Opin Crit Care. 2006 Dec;12(6):557-60. doi: 10.1097/01.ccx.0000247443.86628.68.
- Background: PubMed 22092145Rimes-Stigare C, Awad A, Martensson J, Martling CR, Bell M. Long-term outcome after acute renal replacement therapy: a narrative review. Acta Anaesthesiol Scand. 2012 Feb;56(2):138-46. doi: 10.1111/j.1399-6576.2011.02567.x. Epub 2011 Oct 19.
- Background: PubMed 15385656Go AS, Chertow GM, Fan D, McCulloch CE, Hsu CY. Chronic kidney disease and the risks of death, cardiovascular events, and hospitalization. N Engl J Med. 2004 Sep 23;351(13):1296-305. doi: 10.1056/NEJMoa041031.
- Background: PubMed 22617274Bellomo R, Kellum JA, Ronco C. Acute kidney injury. Lancet. 2012 Aug 25;380(9843):756-66. doi: 10.1016/S0140-6736(11)61454-2. Epub 2012 May 21.
- Background: PubMed 25174800Emilsson L, Lindahl B, Koster M, Lambe M, Ludvigsson JF. Review of 103 Swedish Healthcare Quality Registries. J Intern Med. 2015 Jan;277(1):94-136. doi: 10.1111/joim.12303. Epub 2014 Sep 27.
- Background: PubMed 25270255Adami HO, Hernan MA. Learning how to improve healthcare delivery: the Swedish Quality Registers. J Intern Med. 2015 Jan;277(1):87-9. doi: 10.1111/joim.12315. Epub 2014 Nov 24. No abstract available.
- Derived from this study: PubMed 26526622Rimes-Stigare C, Frumento P, Bottai M, Martensson J, Martling CR, Bell M. Long-term mortality and risk factors for development of end-stage renal disease in critically ill patients with and without chronic kidney disease. Crit Care. 2015 Nov 3;19:383. doi: 10.1186/s13054-015-1101-8.
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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.
Claire Stigare, MD principal investigator
karolinska University Hospital, Karolinska Institute
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Kidney Injury, run by Karolinska Institutet.
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 2 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 24 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Mortality (time frame: 5 year). 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 NCT02424747, which also lists 8 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 24 Apr 2015.