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

NCT ID: NCT04281706

Last Updated: 2023-09-08

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1495 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-10-15
• Study Completion Date: 2021-01-01

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).

Conditions

Postoperative Complications

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Etomidate-Time-Frame

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

Etomidate vs Propofol as induction agent

Intervention Type: DRUG

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

Etomidate vs Propofol as induction agent

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Charite University, Berlin, Germany

OTHER

Sponsor Role: lead

Responsible Party

Felix Balzer

Prof. Dr. Dr. Felix Balzer, MSc; ECDF-Professor for

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Prof. Dr. Dr. Felix Balzer, MSc

Role: PRINCIPAL_INVESTIGATOR

Charite University, Berlin, Germany

Locations

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, , Germany

Countries

Germany

Other Identifiers

EtoProp

Identifier Type: -

Identifier Source: org_study_id