Kidney DiseasesNCT04141072
Shrunken Pore Syndrome: a Retrospective, Single Center, Cohort Study
An observational study of Kidney Diseases, run by Henrik Bjursten at 1 site in Sweden.
Trial summary
To study the impact a difference in renal clearance of small and large molecules has on long-term survival. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Diseases
- What is being tested?
- Shrunken Pore Syndrome
- How many people
- 4,719 participants
- Where
- 1 siteSweden
- Study dates
- 1 Jan 2010to 10 Jan 2019
- How long will I take part?
- 10 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: Skåne University Hospital in Lund is a tertiary care hospital that is the sole provider of cardiac surgery to the Southern part of Sweden, comprising 1 500 000 people.
Who may be able to join
- Elective CABG and/or sAVR at the department of Cardiothoracic Surgery, Skåne University Hospital in Lund, Sweden between 1 January 2010 and 31 December 2015.
Who cannot join
- Emergency operation
- Redo operation
- Preoperatively missing cystatin C or creatinine
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Shrunken Pore Syndrome's Effect on Mortality in Elective Cardiac Surgery
To study the impact a difference in renal clearance of small and large molecules has on long-term survival.
Read the detailed description
Renal dysfunction is considered a major risk factor in cardiac surgery. Renal function has earlier been estimated by creatinine and more recently by cystatin C, both of which are analysed in a blood sample. New evidence seems to suggest that if the ratio between estimated renal function from cystatin C and creatinine is below 60% the patient has a higher rate of mortality irrespective of renal function. This syndrome is named Shrunken Pore Syndrome.
We study patients whom have undergone elective cardiac surgery at our institution and on whom we before the surgery has collected blood samples. They are all included in our in house patient registry and qulaity database and afterwards we match this data to our national tax registry to get data on mortality.
Our aim is to evaluate whether Shrunken Pore Syndrome influence mortality following elective cardiac surgery.
- Conditions
- Kidney Diseases
- Being tested
- Shrunken Pore Syndrome
- Keywords
- CKD, Creatinine, Cystatin C, Cardiac surgery, GFR
- Medical subject headings
- Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shrunken Pore SyndromeDiagnostic test
eGFR Cystatin C ≤ 60% of eGFR Creatinine
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality during follow up
All cause mortality at follow up
Measured: 1 January 2010 - 1 January 2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2019
- Study start1 Jan 2010
- Primary completion30 Dec 2015
- Study completion10 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Kidney DiseasesStudies of the same condition, open and under way.
- 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
- 4,719 participants (actual)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Henrik Bjursten
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Henrik Bjursten, Region Skane
- Investigators
- Henrik Bjursten, MD PhD, Principal investigator, Region Skane
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04141072
- Sponsor's protocol ID
- SPS
- Status last verified
- Sep 2021
- First submitted
- 24 Oct 2019
- Last updated
- 21 Sep 2021
- Results posted
- No
- Individual data sharing
- No
Publications
Dardashti A, Nozohoor S, Grubb A, Bjursten H. Shrunken Pore Syndrome is associated with a sharp rise in mortality in patients undergoing elective coronary artery bypass grafting. Scand J Clin Lab Invest. 2016;76(1):74-81. doi: 10.3109/00365513.2015.1099724.
PubMed 26647957Grubb A, Lindstrom V, Jonsson M, Back SE, Ahlund T, Rippe B, Christensson A. Reduction in glomerular pore size is not restricted to pregnant women. Evidence for a new syndrome: 'Shrunken pore syndrome'. Scand J Clin Lab Invest. 2015 Jul;75(4):333-40. doi: 10.3109/00365513.2015.1025427.
PubMed 25919022Herou E, Dardashti A, Nozohoor S, Zindovic I, Ederoth P, Grubb A, Bjursten H. The mortality increase in cardiac surgery patients associated with shrunken pore syndrome correlates with the eGFRcystatin C/eGFRcreatinine-ratio. Scand J Clin Lab Invest. 2019 May;79(3):167-173. doi: 10.1080/00365513.2019.1576101. Epub 2019 Feb 15.
PubMed 30767571Herou E, Grubb A, Dardashti A, Nozohoor S, Zindovic I, Ederoth P, Bjursten H. Reduced renal elimination of larger molecules is a strong predictor for mortality. Sci Rep. 2022 Oct 20;12(1):17517. doi: 10.1038/s41598-022-22433-4.
PubMed 36266435
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shrunken Pore Syndrome's Effect on Mortality in Elective Cardiac Surgery
- ClinicalTrials.gov ID
- NCT04141072
- Acronym / sponsor ID
- SPS
- Conditions
- Kidney Diseases
- Keywords
- CKD, Creatinine, Cystatin C, Cardiac surgery, GFR
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,719 participants (actual)
- Lead sponsor
- Henrik BjurstenUniversity, hospital or other
- Study start
- 1 Jan 2010 (actual)
- Primary completion
- 30 Dec 2015 (actual)
- Study completion
- 10 Jan 2019 (actual)
- First posted
- 28 Oct 2019 (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.
To study the impact a difference in renal clearance of small and large molecules has on long-term survival.
Detailed description
Renal dysfunction is considered a major risk factor in cardiac surgery. Renal function has earlier been estimated by creatinine and more recently by cystatin C, both of which are analysed in a blood sample. New evidence seems to suggest that if the ratio between estimated renal function from cystatin C and creatinine is below 60% the patient has a higher rate of mortality irrespective of renal function. This syndrome is named Shrunken Pore Syndrome.
We study patients whom have undergone elective cardiac surgery at our institution and on whom we before the surgery has collected blood samples. They are all included in our in house patient registry and qulaity database and afterwards we match this data to our national tax registry to get data on mortality.
Our aim is to evaluate whether Shrunken Pore Syndrome influence mortality following elective cardiac surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Skåne University Hospital in Lund is a tertiary care hospital that is the sole provider of cardiac surgery to the Southern part of Sweden, comprising 1 500 000 people.
Key inclusion criteria (1 listed)
- Elective CABG and/or sAVR at the department of Cardiothoracic Surgery, Skåne University Hospital in Lund, Sweden between 1 January 2010 and 31 December 2015.
Key exclusion criteria (3 listed)
- Emergency operation
- Redo operation
- Preoperatively missing cystatin C or creatinine
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 |
|---|---|---|
| Shrunken Pore SyndromeeGFR Cystatin C ≤ 60% of eGFR Creatinine | Diagnostic test | – |
Primary outcome
Mortality during follow up
Time frame: 1 January 2010 - 1 January 2019
All cause mortality at follow up
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 21 Sep 2021.
- Background: PubMed 26647957Dardashti A, Nozohoor S, Grubb A, Bjursten H. Shrunken Pore Syndrome is associated with a sharp rise in mortality in patients undergoing elective coronary artery bypass grafting. Scand J Clin Lab Invest. 2016;76(1):74-81. doi: 10.3109/00365513.2015.1099724.
- Background: PubMed 25919022Grubb A, Lindstrom V, Jonsson M, Back SE, Ahlund T, Rippe B, Christensson A. Reduction in glomerular pore size is not restricted to pregnant women. Evidence for a new syndrome: 'Shrunken pore syndrome'. Scand J Clin Lab Invest. 2015 Jul;75(4):333-40. doi: 10.3109/00365513.2015.1025427.
- Results publication: PubMed 30767571Herou E, Dardashti A, Nozohoor S, Zindovic I, Ederoth P, Grubb A, Bjursten H. The mortality increase in cardiac surgery patients associated with shrunken pore syndrome correlates with the eGFRcystatin C/eGFRcreatinine-ratio. Scand J Clin Lab Invest. 2019 May;79(3):167-173. doi: 10.1080/00365513.2019.1576101. Epub 2019 Feb 15.
- Derived from this study: PubMed 36266435Herou E, Grubb A, Dardashti A, Nozohoor S, Zindovic I, Ederoth P, Bjursten H. Reduced renal elimination of larger molecules is a strong predictor for mortality. Sci Rep. 2022 Oct 20;12(1):17517. doi: 10.1038/s41598-022-22433-4.
- 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.
Henrik Bjursten, MD PhD principal investigator
Region Skane
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 Kidney Diseases, run by Henrik Bjursten 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 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 21 Sep 2021. 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?
Mortality during follow up (time frame: 1 January 2010 - 1 January 2019). 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 NCT04141072, which also lists 4 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 21 Sep 2021.