Clinical trial NCT04281706: Impact of Etomidate vs. Propofol on Infectious Complications Post Cardiac Surgery
Official title: Impact of Etomidate vs. Propofol on Development of Sepsis and Infectious Complications Post Cardiac Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postoperative Complications
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2020-02-24
Enrollment: 1495
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients that underwent cardiac surgery between October 1st, 2012 and January 31st, 2015

Brief summary: 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.

Detailed 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).

Eligibility criteria: 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

Primary outcomes:
measure: Sepsis
timeFrame: surgical intervention to hospital discharge, average 30 days
Secondary outcomes:
measure: Pneumonia
timeFrame: surgical intervention to hospital discharge, average 30 days
measure: Mediastinitis
timeFrame: surgical intervention to hospital discharge, average 30 days
measure: Surgical Site Infections
timeFrame: surgical intervention to hospital discharge, average 30 days
measure: ICU Mortality
timeFrame: surgical intervention to ICU discharge, average 30 days
measure: Hospital mortality
timeFrame: surgical intervention to hospital discharge, average 30 days
measure: Intensive Care Unit length of stay
timeFrame: ICU admission to ICU discharge, average 30 days
measure: Hospital length of stay
timeFrame: hospital admission to hospital discharge, average 30 days
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Department of Anesthesiology and Operative Intensive Care Medicine (CCM, CVK), Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt Universität zu Berlin and Berlin Institute of Health, Augustenburger Platz 1, 13353
Study officials:
affiliation: Charite University, Berlin, Germany
name: Prof. Dr. Dr. Felix Balzer, MSc
role: PRINCIPAL_INVESTIGATOR
References: