Impact of Etomidate vs. Propofol on Infectious Complications Post Cardiac Surgery

Charité University Medicine Berlin

Status: Completed

Conditions: Postoperative Complications

Treatments: Drug: Etomidate vs Propofol as induction agent

Study type: Observational

Funder types: Other

Identifiers

NCT04281706

EtoProp

Details and patient eligibility

About

The aim of this retrospective before-after-study is to evaluate the potential association of etomidate vs. propofol as an induction agent for major cardiac surgery on infectious post-operative complications.

The investigators hypothesize that etomidate increases the rate post-operative infectious complications in cardiosurgical patients.

Full description

Etomidate had been a standard induction agent as it results in increased hemodynamic stability compared to propofol. This is seen as a major advantage in patients that frequently have a fragile haemodynamic situation.

A major side effect of Etomidate is the resulting adrenal dysfunction, which hampers the bodies stress response and has been shown to cause a higher mortality in infectious contexts such as sepsis. It remains unclear to what extend this attenuated stress response has an impact on the post-operative context in cardiosurgical patients. First preliminary data show that patients receiving Etomidate as an induction agent are more prone to infection than those receiving a different agent, a definitive correlation is nevertheless still lacking.

This is a retrospective before-after-study comparing the rate of infectious complications in patients receiving either valve and/or coronary cardiac surgery at the Charité - Universitätsmedizin Berlin between October 1st, 2012 and January 31th, 2015. On October 1st, 2013 the standard operating procedures for anesthesia for cardiac surgery were amended and the induction agent at the Charité - Universitätsmedizin Berlin was switched from Etomidate to Propofol. The investigators are therefore comparing patients undergoing cardiac surgery between October 1st, 2012 and September 30th, 2013 as the Etomidate group with patients undergoing surgery between February 1st, 2014 and January 31st, 2015 as the Propofol group. The gap in between the two groups (October 1st, 2013 - January 31st, 2014) was defined as a washout phase to account for a potential delay in implementation of the renewed standard operating procedures. Patients will be investigated unmatched as well as matched according to (Age, Body Mass Index, American Society of Anesthesiologists physical status classification system (ASA), New York Heart Association Functional Classification (NYHA), Surgical Mode and Diabetes). The data for both groups will be acquired from the 2 electronic patient data management systems at our hospital (COPRA System, Sasbachwalden, Germany, and SAP, Walldorf, Germany).

Enrollment: 1,495 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ≥ 18 years of age
• Valve and/or coronary artery bypass graft surgery

Exclusion criteria

• Surgery during washout period (October 1st, 2013 - January 31st, 2014)
• Resurgery
• Endocarditis
• Known immunosuppression:
• Corticosteroid therapy
• Solid organ transplant
• Stem Cell therapy
• HIV diagnosis

Trial design

1,495 participants in 2 patient groups

Etomidate-Time-Frame

Description:

Patients that underwent cardiac surgery between October 1st, 2012 and September 30th, 2013

Treatment:

Drug: Etomidate vs Propofol as induction agent

Propofol-Time-Frame

Description:

Patients that underwent cardiac surgery between February 1st, 2014 and January 31st, 2015

Treatment:

Drug: Etomidate vs Propofol as induction agent