Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT04281706 |
Other study ID # |
EtoProp |
Secondary ID |
|
Status |
Completed |
Phase |
|
First received |
|
Last updated |
|
Start date |
October 15, 2019 |
Est. completion date |
January 1, 2021 |
Study information
Verified date |
September 2023 |
Source |
Charite University, Berlin, Germany |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial 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.
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).