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

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

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Complications
• Intervention / Treatment: Drug: Etomidate vs Propofol as induction agent

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).

• Study Type: Observational
• Enrollment (Actual): 1495

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 13353
    • 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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Patients that underwent cardiac surgery between October 1st, 2012 and January 31st, 2015

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Etomidate-Time-Frame; Patients that underwent cardiac surgery between October 1st, 2012 and September 30th, 2013	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.
Propofol-Time-Frame; Patients that underwent cardiac surgery between February 1st, 2014 and January 31st, 2015	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pneumonia	Incidence of pneumonia within between surgical intervention and hospital discharge	surgical intervention to hospital discharge, average 30 days
Mediastinitis	Incidence of mediastinitis within between surgical intervention and hospital discharge	surgical intervention to hospital discharge, average 30 days
Surgical Site Infections	Incidence of surgical site infections between surgical intervention and hospital discharge	surgical intervention to hospital discharge, average 30 days
ICU Mortality	Proportion of patients that died before ICU discharge	surgical intervention to ICU discharge, average 30 days
Hospital mortality	Proportion of patients that died before hospital discharge	surgical intervention to hospital discharge, average 30 days
Intensive Care Unit length of stay	Time patients spend on the ICU	ICU admission to ICU discharge, average 30 days
Hospital length of stay	Time patients spend admitted to the hospital	hospital admission to hospital discharge, average 30 days

Collaborators and Investigators

• Sponsor: Charite University, Berlin, Germany
• Investigators: Principal Investigator: Prof. Dr. Dr. Felix Balzer, MSc, Charite University, Berlin, Germany

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2019
• Primary Completion (Actual): January 1, 2021
• Study Completion (Actual): January 1, 2021

Study Registration Dates

• First Submitted: January 27, 2020
• First Submitted That Met QC Criteria: February 21, 2020
• First Posted (Actual): February 24, 2020

Study Record Updates

• Last Update Posted (Actual): September 8, 2023
• Last Update Submitted That Met QC Criteria: September 7, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Hypnotics and Sedatives; Propofol; Etomidate
• Other Study ID Numbers: EtoProp

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No