NCT02692833

Brief Summary

The purpose of this study is to investigate whether biomarkers of cell senescence and aging can predict the development of acute kidney injury following cardiac surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
254

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2016

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, 2016

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

January 22, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 26, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

September 20, 2017

Status Verified

September 1, 2016

Enrollment Period

1.3 years

First QC Date

January 22, 2016

Last Update Submit

September 18, 2017

Conditions

Acute Kidney InjuryHeart Valve DiseasesCoronary Artery Disease

Keywords

TelomereTelomeraseDNA methylationCell agingThoracic Surgery

Outcome Measures

Primary Outcomes (1)

  • Acute Kidney Injury

    The development of acute kidney injury in the first 5 days of surgery.

    5 days

Secondary Outcomes (3)

  • In hospital mortality

    30 days

  • Major adverse cardiac and cerebrovascular events

    30 days

  • length of stay

    Will be assessed upon patient's discharge from hospital. Typically 5-10 days but variable

Study Arms (2)

AKI Patients

Patients who develop acute kidney injury within the first 5 days following their cardiac surgical operation.

Other: No intervention

Non-AKI patients

Patients who do not develop acute kidney injury within the first 5 days following their cardiac surgical operation.

Other: No intervention

Interventions

No interventionOTHER

No intervention. This is an observational study of how patients' renal function responds to their surgery. The groups are defined by this response. There is no difference between clinical interventions between the two groups.

AKI PatientsNon-AKI patients

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients undergoing cardiac surgery

You may qualify if:

  • All adult patients undergoing cardiac surgery at Barts Heart Centre

You may not qualify if:

  • Renal dialysis patients
  • Renal transplant patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St Bartholomew's Hospital

London, EC1A 7BE, United Kingdom

Location

Related Publications (4)

  • Thakar CV, Arrigain S, Worley S, Yared JP, Paganini EP. A clinical score to predict acute renal failure after cardiac surgery. J Am Soc Nephrol. 2005 Jan;16(1):162-8. doi: 10.1681/ASN.2004040331. Epub 2004 Nov 24.

    PMID: 15563569BACKGROUND

  • Hobson CE, Yavas S, Segal MS, Schold JD, Tribble CG, Layon AJ, Bihorac A. Acute kidney injury is associated with increased long-term mortality after cardiothoracic surgery. Circulation. 2009 May 12;119(18):2444-53. doi: 10.1161/CIRCULATIONAHA.108.800011. Epub 2009 Apr 27.

    PMID: 19398670BACKGROUND

  • Loef BG, Epema AH, Smilde TD, Henning RH, Ebels T, Navis G, Stegeman CA. Immediate postoperative renal function deterioration in cardiac surgical patients predicts in-hospital mortality and long-term survival. J Am Soc Nephrol. 2005 Jan;16(1):195-200. doi: 10.1681/ASN.2003100875. Epub 2004 Nov 24.

    PMID: 15563558BACKGROUND

  • Westhoff JH, Schildhorn C, Jacobi C, Homme M, Hartner A, Braun H, Kryzer C, Wang C, von Zglinicki T, Kranzlin B, Gretz N, Melk A. Telomere shortening reduces regenerative capacity after acute kidney injury. J Am Soc Nephrol. 2010 Feb;21(2):327-36. doi: 10.1681/ASN.2009010072. Epub 2009 Dec 3.

    PMID: 19959722BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples collected for: Peripheral Blood Mononuclear Cells (PBMC) DNA extraction from buffy coat Right atrial tissue samples (subset) Urine and plasma/serum for urinary biomarkers (subset)

MeSH Terms

Conditions

Acute Kidney InjuryHeart Valve DiseasesCoronary Artery Disease

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesHeart DiseasesCardiovascular DiseasesCoronary DiseaseMyocardial IschemiaArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Magdi M Yaqoob, PhD

    Queen mary Univerisity of London

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
7 Days
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 22, 2016

First Posted

February 26, 2016

Study Start

January 1, 2016

Primary Completion

May 1, 2017

Study Completion

May 1, 2017

Last Updated

September 20, 2017

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will not share

We do not plan to share individual participant data outside of our research group

Locations

GB(1)