Shrunken Pore Syndrome: a Retrospective, Single Center, Cohort Study

Kidney Diseases Clinical Trial

Official title:

Shrunken Pore Syndrome's Effect on Mortality in Elective Cardiac Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04141072
• Other study ID #: SPS
• Status: Completed
• Start date: January 1, 2010
• Est. completion date: January 10, 2019

Study information

• Verified date: September 2021
• Source: Region Skane
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

To study the impact a difference in renal clearance of small and large molecules has on long-term survival.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4719
• Est. completion date: January 10, 2019
• Est. primary completion date: December 30, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Kidney Diseases

Intervention

Diagnostic Test:
• Shrunken Pore Syndrome
eGFR Cystatin C = 60% of eGFR Creatinine

Locations

Country	Name	City	State
Sweden	Skåne University Hospital	Lund	Skåne

Sponsors (1)

Lead Sponsor	Collaborator
Henrik Bjursten

Country where clinical trial is conducted

Sweden, 

References & Publications (3)

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. — View Citation

Grubb A, Lindström V, Jonsson M, Bäck SE, Åhlund 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. — View 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 eGFR(cystatin C)/eGFR(creatinine)-ratio. Scand J Clin Lab Invest. 2 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality during follow up	All cause mortality at follow up	1 January 2010 - 1 January 2019