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

Postoperative Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04281706
• Other study ID #: EtoProp
• Status: Completed
• 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
• 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1495
• Est. completion date: January 1, 2021
• Est. primary completion date: January 1, 2021
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Postoperative Complications

Intervention

Drug:
• Etomidate vs Propofol as induction agent
Patients undergoing cardiac surgery were induced with Etomidate according to the standard operating procedure for induction until October 1st, 2013, afterwards a new SOP with Propofol as primary induction agent was introduced. After a washout period of 3 months, Propofol was used as sole induction agent. The rest of the standard operating procedure remained the same.

Locations

Country	Name	City	State
Germany	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	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sepsis	Incidence of sepsis according to diagnosis-related group coding between surgical intervention and hospital discharge (according to SEPSIS II)	surgical intervention to hospital discharge, average 30 days
Secondary	Pneumonia	Incidence of pneumonia within between surgical intervention and hospital discharge	surgical intervention to hospital discharge, average 30 days
Secondary	Mediastinitis	Incidence of mediastinitis within between surgical intervention and hospital discharge	surgical intervention to hospital discharge, average 30 days
Secondary	Surgical Site Infections	Incidence of surgical site infections between surgical intervention and hospital discharge	surgical intervention to hospital discharge, average 30 days
Secondary	ICU Mortality	Proportion of patients that died before ICU discharge	surgical intervention to ICU discharge, average 30 days
Secondary	Hospital mortality	Proportion of patients that died before hospital discharge	surgical intervention to hospital discharge, average 30 days
Secondary	Intensive Care Unit length of stay	Time patients spend on the ICU	ICU admission to ICU discharge, average 30 days
Secondary	Hospital length of stay	Time patients spend admitted to the hospital	hospital admission to hospital discharge, average 30 days