Clinical trial NCT04141072: Shrunken Pore Syndrome: a Retrospective, Single Center, Cohort Study
Official title: Shrunken Pore Syndrome's Effect on Mortality in Elective Cardiac Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Kidney Diseases
Keywords: CKD
Creatinine
Cystatin C
Cardiac surgery
GFR
Lead sponsor: Region Skane
Sponsor class: OTHER
First posted: 2019-10-28
Enrollment: 4719
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Emergency operation
* Redo operation
* Preoperatively missing cystatin C or creatinine

Primary outcomes:
measure: Mortality during follow up
timeFrame: 1 January 2010 - 1 January 2019
Secondary outcomes:
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Skåne University Hospital
state: Skåne
Study officials:
affiliation: Region Skåne
name: Henrik Bjursten, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Grubb 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.
citation: Herou 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.
citation: Herou 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.