Effects of the implementation of a specific Safety Checklist in cardiac surgery

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN16953845

Enrollment

6000

Registered

2018-06-14

Start date

2015-01-01

Completion date

Unknown

Last updated

2018-07-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adult cardiac surgery patients Surgery

Interventions

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 ch

Eligibility

Sex/Gender

All

Inclusion criteria

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)

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
120-day mortality; data retrieved from electronic database of the regional municipal administration	—

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

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Countries

Netherlands

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026