Shrunken Pore Syndrome: a Retrospective, Single Center, C... | NCT04141072

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

NCT04141072

Sponsor

Henrik Bjursten

Status

Completed

Last Update Posted

Sep 21, 2021Actual

Enrollment

4,719Actual

Phase

Not provided

Conditions

Kidney Diseases

Interventions

Shrunken Pore Syndrome

Countries

Sweden

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2010Actual

Primary Completion Date

Dec 30, 2015Actual

Completion Date

Jan 10, 2019Actual

First Submitted Date

Oct 24, 2019

First Submission Date that Met QC Criteria

Oct 25, 2019

First Posted Date

Oct 28, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 14, 2021

Last Update Posted Date

Sep 21, 2021Actual

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

10 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

4,719Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Shrunken Pore Syndrome	Diagnostic Test	eGFR Cystatin C ≤ 60% of eGFR Creatinine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mortality during follow up	All cause mortality at follow up	1 January 2010 - 1 January 2019

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder 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.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Henrik Bjursten, MD PhD	Region Skane	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Skåne University Hospital		Lund	Skåne County	22241	Sweden

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26647957	Background	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.
25919022	Background	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.

ID	Term
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases