NCT04141072

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,719

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2015

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2019

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 24, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 28, 2019

Completed
Last Updated

September 21, 2021

Status Verified

September 1, 2021

Enrollment Period

6 years

First QC Date

October 24, 2019

Last Update Submit

September 14, 2021

Conditions

Keywords

CKDCreatinineCystatin CCardiac surgeryGFR

Outcome Measures

Primary Outcomes (1)

  • Mortality during follow up

    All cause mortality at follow up

    1 January 2010 - 1 January 2019

Interventions

Shrunken Pore SyndromeDIAGNOSTIC_TEST

eGFR Cystatin C ≤ 60% of eGFR Creatinine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Skåne University Hospital

Lund, Skåne County, 22241, Sweden

Location

Related Publications (4)

  • 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.

    PMID: 26647957BACKGROUND
  • 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.

    PMID: 25919022BACKGROUND
  • 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.

  • 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.

MeSH Terms

Conditions

Kidney Diseases

Condition Hierarchy (Ancestors)

Urologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Henrik Bjursten, MD PhD

    Region Skåne

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assoc. Prof

Study Record Dates

First Submitted

October 24, 2019

First Posted

October 28, 2019

Study Start

January 1, 2010

Primary Completion

December 30, 2015

Study Completion

January 10, 2019

Last Updated

September 21, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations