NCT02535728

Brief Summary

A prospective observational cohort study to assess the predictive value of preoperative frailty on postoperative quality of life in cardiac surgery patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
577

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2015

Typical duration 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

July 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 24, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 31, 2015

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

March 6, 2018

Status Verified

March 1, 2018

Enrollment Period

2.4 years

First QC Date

August 24, 2015

Last Update Submit

March 4, 2018

Conditions

Quality of Life

Keywords

Frail ElderlyCardiac Surgical ProcedureRisk AssessmentQuality of Life

Outcome Measures

Primary Outcomes (1)

  • Quality of Life Assessed by Short Form-36 (SF-36)

    Assessed by Short Form-36 (SF-36)

    12 months after surgery

Secondary Outcomes (6)

  • Quality of Life Assessed by Short Form-36 (SF-36)

    3 months after surgery

  • Psychosocial or physical functioning Assessed by World Health Organisation Disability Assessment Schedule 2.0

    3 and 12 months after surgery

  • Incidence of postoperative complications

    30 days after surgery

  • Mortality

    30 days and 12 months after surgery

  • Length of stay in hospital and ICU

    Post-Surgery. The expected length of stay in the ICU is 1 to 5 days and in hospital 5 to 10 days.

  • +1 more secondary outcomes

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodProbability Sample
Study Population

All patients planned for elective cardiac surgery and aged 70 years or older.

You may qualify if:

  • Aged 70 years or older
  • Mentally competent
  • Planned cardiac surgery (coronary, valvular, rhythm, aortic or combination of those)
  • Signed informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St Antonius hospital

Nieuwegein, Utrecht, 3435 CM, Netherlands

Location

Related Publications (8)

  • Fruitman DS, MacDougall CE, Ross DB. Cardiac surgery in octogenarians: can elderly patients benefit? Quality of life after cardiac surgery. Ann Thorac Surg. 1999 Dec;68(6):2129-35. doi: 10.1016/s0003-4975(99)00818-8.

    PMID: 10616989BACKGROUND

  • Chaturvedi RK, Blaise M, Verdon J, Iqbal S, Ergina P, Cecere R, deVarennes B, Lachapelle K. Cardiac surgery in octogenarians: long-term survival, functional status, living arrangements, and leisure activities. Ann Thorac Surg. 2010 Mar;89(3):805-10. doi: 10.1016/j.athoracsur.2009.12.002.

    PMID: 20172133BACKGROUND

  • Ettema RG, Peelen LM, Kalkman CJ, Nierich AP, Moons KG, Schuurmans MJ. Predicting prolonged intensive care unit stays in older cardiac surgery patients: a validation study. Intensive Care Med. 2011 Sep;37(9):1480-7. doi: 10.1007/s00134-011-2314-1. Epub 2011 Jul 30.

    PMID: 21805158BACKGROUND

  • Afilalo J, Mottillo S, Eisenberg MJ, Alexander KP, Noiseux N, Perrault LP, Morin JF, Langlois Y, Ohayon SM, Monette J, Boivin JF, Shahian DM, Bergman H. Addition of frailty and disability to cardiac surgery risk scores identifies elderly patients at high risk of mortality or major morbidity. Circ Cardiovasc Qual Outcomes. 2012 Mar 1;5(2):222-8. doi: 10.1161/CIRCOUTCOMES.111.963157. Epub 2012 Mar 6.

    PMID: 22396586BACKGROUND

  • Arends BC, Timmerman L, Vernooij LM, Verwijmeren L, Biesma DH, van Dongen EPA, Noordzij PG, van Oud-Alblas HJB. Preoperative frailty and chronic pain after cardiac surgery: a prospective observational study. BMC Anesthesiol. 2022 Jul 1;22(1):201. doi: 10.1186/s12871-022-01746-x.

    PMID: 35778674DERIVED

  • Verwijmeren L, Noordzij PG, Daeter EJ, Emmelot-Vonk MH, Vernooij LM, van Klei WA, van Dongen EPA. Preoperative frailty and one-year functional recovery in elderly cardiac surgery patients. J Thorac Cardiovasc Surg. 2023 Sep;166(3):870-878.e6. doi: 10.1016/j.jtcvs.2022.01.032. Epub 2022 Feb 3.

    PMID: 35272845DERIVED

  • Verwijmeren L, Bosma M, Vernooij LM, Linde EM, Dijkstra IM, Daeter EJ, Van Dongen EPA, Van Klei WA, Noordzij PG. Associations Between Preoperative Biomarkers and Cardiac Surgery-Associated Acute Kidney Injury in Elderly Patients: A Cohort Study. Anesth Analg. 2021 Sep 1;133(3):570-577. doi: 10.1213/ANE.0000000000005650.

    PMID: 34153017DERIVED

  • Verwijmeren L, Peelen LM, van Klei WA, Daeter EJ, van Dongen EPA, Noordzij PG. Anaesthesia geriatric evaluation to guide patient selection for preoperative multidisciplinary team care in cardiac surgery. Br J Anaesth. 2020 Apr;124(4):377-385. doi: 10.1016/j.bja.2019.12.042. Epub 2020 Feb 14.

    PMID: 32063340DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples are taken directly after induction of anesthaesia.

Study Officials

  • Peter G Noordzij, MD, PhD

    St. Antonius Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
dr. P. Noordzij, MD PhD

Study Record Dates

First Submitted

August 24, 2015

First Posted

August 31, 2015

Study Start

July 1, 2015

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

March 6, 2018

Record last verified: 2018-03

Locations

NL(1)