NCT03913299

Brief Summary

The aim of the study is to assess frailty of patients admited for cardio-vascular surgery in Cliniques Universitaires Saint Luc in Brussels. And analyse the correlation between frailty, functionnal decline and postoperative mortality.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
2,080

participants targeted

Target at P75+ for all trials

Timeline
5mo left

Started Apr 2019

Longer than P75 for all trials

Geographic Reach
1 country

3 active sites

Status
active not recruiting

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 Progress95%
Apr 2019Sep 2026

First Submitted

Initial submission to the registry

April 11, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 12, 2019

Completed
11 days until next milestone

Study Start

First participant enrolled

April 23, 2019

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2025

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2026

Expected
Last Updated

April 15, 2025

Status Verified

April 1, 2025

Enrollment Period

5.9 years

First QC Date

April 11, 2019

Last Update Submit

April 10, 2025

Conditions

Keywords

FrailtyCardiac surgeryVascular surgery

Outcome Measures

Primary Outcomes (2)

  • Mortality

    1 year

  • Functionnal decline

    Admission to a nursing home (yes or no) or care dependency (defined by a Katz index higher than 0/6)

    1 year

Eligibility Criteria

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

All consecutive patients older than 18 years of age admitted for cardiac surgery or vascular surgery in Cliniques Universitaires Saint-Luc in Brussels will be included.

You may qualify if:

  • Any cardiac surgery under cardiopulmonary bypass
  • Any vascular surgery

You may not qualify if:

  • Salvage surgery
  • Cirrhosis CHILD B or C

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

St Luc University Hospital UCLouvain

Brussels, Belgium

Location

Grand Hopital Charleroi

Charleroi, 6060, Belgium

Location

Centre Hospitalier Universitaire de Liège

Liège, 4000, Belgium

Location

Related Publications (18)

  • Clegg A, Young J, Iliffe S, Rikkert MO, Rockwood K. Frailty in elderly people. Lancet. 2013 Mar 2;381(9868):752-62. doi: 10.1016/S0140-6736(12)62167-9. Epub 2013 Feb 8.

    PMID: 23395245BACKGROUND
  • Fried LP, Ferrucci L, Darer J, Williamson JD, Anderson G. Untangling the concepts of disability, frailty, and comorbidity: implications for improved targeting and care. J Gerontol A Biol Sci Med Sci. 2004 Mar;59(3):255-63. doi: 10.1093/gerona/59.3.m255.

    PMID: 15031310BACKGROUND
  • Nashef SA, Roques F, Sharples LD, Nilsson J, Smith C, Goldstone AR, Lockowandt U. EuroSCORE II. Eur J Cardiothorac Surg. 2012 Apr;41(4):734-44; discussion 744-5. doi: 10.1093/ejcts/ezs043. Epub 2012 Feb 29.

    PMID: 22378855BACKGROUND
  • Anderson RP. First publications from the Society of Thoracic Surgeons National Database. Ann Thorac Surg. 1994 Jan;57(1):6-7. doi: 10.1016/0003-4975(94)90355-7. No abstract available.

    PMID: 8279920BACKGROUND
  • Sundermann S, Dademasch A, Praetorius J, Kempfert J, Dewey T, Falk V, Mohr FW, Walther T. Comprehensive assessment of frailty for elderly high-risk patients undergoing cardiac surgery. Eur J Cardiothorac Surg. 2011 Jan;39(1):33-7. doi: 10.1016/j.ejcts.2010.04.013.

    PMID: 20627611BACKGROUND
  • Bagshaw SM, Stelfox HT, Johnson JA, McDermid RC, Rolfson DB, Tsuyuki RT, Ibrahim Q, Majumdar SR. Long-term association between frailty and health-related quality of life among survivors of critical illness: a prospective multicenter cohort study. Crit Care Med. 2015 May;43(5):973-82. doi: 10.1097/CCM.0000000000000860.

    PMID: 25668751BACKGROUND
  • Ferrante LE, Pisani MA, Murphy TE, Gahbauer EA, Leo-Summers LS, Gill TM. The Association of Frailty With Post-ICU Disability, Nursing Home Admission, and Mortality: A Longitudinal Study. Chest. 2018 Jun;153(6):1378-1386. doi: 10.1016/j.chest.2018.03.007. Epub 2018 Mar 17.

    PMID: 29559308BACKGROUND
  • Le Maguet P, Roquilly A, Lasocki S, Asehnoune K, Carise E, Saint Martin M, Mimoz O, Le Gac G, Somme D, Cattenoz C, Feuillet F, Malledant Y, Seguin P. Prevalence and impact of frailty on mortality in elderly ICU patients: a prospective, multicenter, observational study. Intensive Care Med. 2014 May;40(5):674-82. doi: 10.1007/s00134-014-3253-4. Epub 2014 Mar 21.

    PMID: 24651884BACKGROUND
  • Muscedere J, Waters B, Varambally A, Bagshaw SM, Boyd JG, Maslove D, Sibley S, Rockwood K. The impact of frailty on intensive care unit outcomes: a systematic review and meta-analysis. Intensive Care Med. 2017 Aug;43(8):1105-1122. doi: 10.1007/s00134-017-4867-0. Epub 2017 Jul 4.

    PMID: 28676896BACKGROUND
  • Smart R, Carter B, McGovern J, Luckman S, Connelly A, Hewitt J, Quasim T, Moug S. Frailty Exists in Younger Adults Admitted as Surgical Emergency Leading to Adverse Outcomes. J Frailty Aging. 2017;6(4):219-223. doi: 10.14283/jfa.2017.28.

    PMID: 29165541BACKGROUND
  • Bagshaw M, Majumdar SR, Rolfson DB, Ibrahim Q, McDermid RC, Stelfox HT. A prospective multicenter cohort study of frailty in younger critically ill patients. Crit Care. 2016 Jun 6;20(1):175. doi: 10.1186/s13054-016-1338-x.

    PMID: 27263535BACKGROUND
  • Brummel NE, Bell SP, Girard TD, Pandharipande PP, Jackson JC, Morandi A, Thompson JL, Chandrasekhar R, Bernard GR, Dittus RS, Gill TM, Ely EW. Frailty and Subsequent Disability and Mortality among Patients with Critical Illness. Am J Respir Crit Care Med. 2017 Jul 1;196(1):64-72. doi: 10.1164/rccm.201605-0939OC.

    PMID: 27922747BACKGROUND
  • Sundermann S, Dademasch A, Rastan A, Praetorius J, Rodriguez H, Walther T, Mohr FW, Falk V. One-year follow-up of patients undergoing elective cardiac surgery assessed with the Comprehensive Assessment of Frailty test and its simplified form. Interact Cardiovasc Thorac Surg. 2011 Aug;13(2):119-23; discussion 123. doi: 10.1510/icvts.2010.251884. Epub 2011 Mar 4.

    PMID: 21378017BACKGROUND
  • Rockwood K, Song X, MacKnight C, Bergman H, Hogan DB, McDowell I, Mitnitski A. A global clinical measure of fitness and frailty in elderly people. CMAJ. 2005 Aug 30;173(5):489-95. doi: 10.1503/cmaj.050051.

    PMID: 16129869BACKGROUND
  • Rolfson DB, Majumdar SR, Tsuyuki RT, Tahir A, Rockwood K. Validity and reliability of the Edmonton Frail Scale. Age Ageing. 2006 Sep;35(5):526-9. doi: 10.1093/ageing/afl041. Epub 2006 Jun 6. No abstract available.

    PMID: 16757522BACKGROUND
  • Katz S, Downs TD, Cash HR, Grotz RC. Progress in development of the index of ADL. Gerontologist. 1970 Spring;10(1):20-30. doi: 10.1093/geront/10.1_part_1.20. No abstract available.

    PMID: 5420677BACKGROUND
  • Kobe AR, Meyer A, Elmubarak H, Kempfert J, Pavicevic J, Maisano F, Walther T, Falk V, Sundermann SH. Frailty Assessed by the FORECAST Is a Valid Tool to Predict Short-Term Outcome After Transcatheter Aortic Valve Replacement. Innovations (Phila). 2016 Nov/Dec;11(6):407-413. doi: 10.1097/IMI.0000000000000321.

    PMID: 27926626BACKGROUND
  • Reichart D, Rosato S, Nammas W, Onorati F, Dalen M, Castro L, Gherli R, Gatti G, Franzese I, Faggian G, De Feo M, Khodabandeh S, Santarpino G, Rubino AS, Maselli D, Nardella S, Salsano A, Nicolini F, Zanobini M, Saccocci M, Bounader K, Kinnunen EM, Tauriainen T, Airaksinen J, Seccareccia F, Mariscalco G, Ruggieri VG, Perrotti A, Biancari F. Clinical frailty scale and outcome after coronary artery bypass grafting. Eur J Cardiothorac Surg. 2018 Dec 1;54(6):1102-1109. doi: 10.1093/ejcts/ezy222.

    PMID: 29897529BACKGROUND

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Melanie Dechamps, MD

    St Luc University Hospital UCLouvain

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

April 11, 2019

First Posted

April 12, 2019

Study Start

April 23, 2019

Primary Completion

April 1, 2025

Study Completion (Estimated)

September 30, 2026

Last Updated

April 15, 2025

Record last verified: 2025-04

Locations