Condition category
Surgery
Date applied
12/06/2018
Date assigned
14/06/2018
Last edited
14/06/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Cardiac (heart) surgery has become a routine procedure with acceptable risks. However, there is still room for improvement, especially in elderly patients with multiple comorbidities (illnesses). Each of these conditions may require special measures during or shortly after the operation. In these complex situations checklists may help to structure and improve communication between different caregivers. A specific cardiac surgery safety checklist was developed in one hospital (Isala) and then implemented in six other Dutch cardiac centers. This safety checklist focuses on pre-operative known risk factors in combination with a trans-esophageal echo (an ultrasound scan of the heart) that is performed just after induction of anesthesia.

Who can participate?
Adult cardiac surgery patients

What does the study involve?
Participating cardiac centers introduce the safety checklist. The use of the checklist is strongly encouraged but not obligatory. Patients who are operated with the use of the safety checklist are compared with those who are operated without. 30-day and 120-day mortality (death rates), surgical re-exploration, 72-hour stroke and deep sternal wound infections are compared between the groups.

What are the possible benefits and risks of participating?
The benefit of participating is that patient safety may be improved by systematically checking all the possible risk factors for preoperative complications. There is a small risk that the initial operation plan will be adapted. However, these adaptations are meant to increase patient safety and to prevent possible harmful situations.

Where is the study run from?
1. Isala Hospital, Zwolle (Netherlands)
2. Medisch Spectrum Twente (Netherlands)
3. Antonius Hospital Nieuwegein (Netherlands)
4. OLVG (Netherlands)
5. Catharina Hospital (Netherlands)
6. HAGA teaching hospitals (Netherlands)
7. Amphia (Netherlands)

When is the study starting and how long is it expected to run for?
May 2014 to December 2015

Who is funding the study?
Achmea Healthcare (Netherlands)

Who is the main contact?
Mr Alexander Spanjersberg

Trial website

Contact information

Type

Scientific

Primary contact

Mr Alexander Spanjersberg

ORCID ID

Contact details

Dr van Heesweg 2
Zwolle
8025AB
Netherlands

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Z528-2

Study information

Scientific title

Effects of the implementation of a specific cardiac surgery checklist on mortality in 7 Dutch cardiac centers

Acronym

Study hypothesis

Implementing a specific cardiac surgery safety checklist in multiple cardiac surgery centers results in lower mortality and major complications.

Ethics approval

Committee on Research Ethics of Isala Hospital in Zwolle the Netherlands considered that no further approval was necessary as this is a retrospective study on routine data, 14/08/2014, METC nr 14.08113

Study design

Multicenter observational cohort study during a one-year implementation phase

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Adult cardiac surgery patients

Intervention

Participating centers started to implement the safety checklist from 01/01/2015 and all adult patients undergoing cardiac surgery in one of the participating hospitals were eligible. The use of the checklist was strongly encouraged, but not obligatory. The studied patient population was limited to coronary artery bypass grafting (CABG), surgical aortic valve replacement (AVR), combination of both, and mitral valve surgery (MVS). Patients who were operated on with the use of the safety checklist were compared with those who were operated without.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

120-day mortality; data retrieved from electronic database of the regional municipal administration

Secondary outcome measures

1. 30-day mortality; data retrieved from electronic database of the regional municipal administration
2. 72-hour stroke; data retrieved from active reporting of participating hospital; stroke is defined as a stroke diagnosed by a neurologist (not TIA), within 72 hours after primary surgery.
3. Surgical re-exploration: data from active reporting; surgical re-exploration is defined as every opening of the thorax after primary closure within 30 days after primary surgery. Causes may be bleeding, tamponade or other, but not mediastinitis
4. Deep sternal wound infection (DSWI); data from active reporting; DSWI is defined as deep sternal wound infection within 30 days after primary surgery

Overall trial start date

27/05/2014

Overall trial end date

31/12/2015

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Adult cardiac surgery patients
2. Undergoing coronary artery bypass grafting (CABG), surgical aortic valve replacement (AVR), AVR combined with CABG, and mitral valve surgery (MVS)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

The one year study period in 7 Dutch centers will render about 6000 patients undergoing CABG, AVR, AVR+CABG and MVS

Participant exclusion criteria

Data not available on:
1. Type of surgery
2. Use of safety checklist

Recruitment start date

01/01/2015

Recruitment end date

31/12/2015

Locations

Countries of recruitment

Netherlands

Trial participating centre

Isala Hospital, Zwolle
Dr van Heesweg 2
Zwolle
8025AB
Netherlands

Trial participating centre

Medisch Spectrum Twente
Koningsplein 1
Enschede
7512 KZ
Netherlands

Trial participating centre

Antonius Hospital Nieuwegein
Koekoekslaan 1
Nieuwegein
3435 CM
Netherlands

Trial participating centre

OLVG
Oosterpark 9
Amsterdam
1091 AC
Netherlands

Trial participating centre

Catharina Hospital
Michelangelolaan 2
Eindhoven
5623 EJ
Netherlands

Trial participating centre

HAGA teaching hospitals
Els Borst-Eilersplein 275
The Hague
2545 AA
Netherlands

Trial participating centre

Amphia
Molengracht 21
Breda
4818 CK
Netherlands

Sponsor information

Organisation

Achmea Healthcare

Sponsor details

Burgemeester Roelenweg 13
Zwolle
8021 EV
Netherlands

Sponsor type

Other

Website

achmea.nl

Organisation

Isala Academy

Sponsor details

Dr Van Heesweg 2
Zwolle
8025 AB
Netherlands

Sponsor type

Hospital/treatment centre

Website

www.isala.nl/academie

Funders

Funder type

Other

Funder name

Achmea Healthcare

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Main article will be submitted summer 2018. Presentation on ESC congress 2018 Munich.

IPD sharing statement
The dataset will not be directly available, as data ownership is at the participating centers. In the agreement with the participating centers it is stated that data may only be analyzed for the purpose of this study. If there is a request, the participating centers have to be asked for permission to use the data for a new purpose. In the meantime data are held at the national institution: Netherlands Heart Registry.

Intention to publish date

01/08/2018

Participant level data

Not expected to be available

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes