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

NCT04281706 | Completed

• 1 other identifier: EtoProp
• Study Type: observational
• Target: 1,495
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Complications

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Pneumonia

  surgical intervention to hospital discharge, average 30 days

• Mediastinitis

  surgical intervention to hospital discharge, average 30 days

• Surgical Site Infections

  surgical intervention to hospital discharge, average 30 days

• ICU Mortality

  surgical intervention to ICU discharge, average 30 days

• Hospital mortality

  surgical intervention to hospital discharge, average 30 days

Study Arms (2)

Etomidate-Time-Frame

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

Drug: Etomidate vs Propofol as induction agent

Propofol-Time-Frame

Patients that underwent cardiac surgery between February 1st, 2014 and January 31st, 2015

Drug: Etomidate vs Propofol as induction agent

Interventions

Etomidate vs Propofol as induction agent 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.

Etomidate-Time-Frame; Propofol-Time-Frame

Eligibility Criteria

• Age: 18 Years - 100 Years
• Gender Eligibility Details: all gender are eligible.
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• ≥ 18 years of age
• Valve and/or coronary artery bypass graft surgery

You may not qualify if:

• Surgery during washout period (October 1st, 2013 - January 31st, 2014)
• Resurgery
• Endocarditis
• Known immunosuppression:
• Corticosteroid therapy
• Solid organ transplant
• Stem Cell therapy
• HIV diagnosis

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (1)

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, 13353, Germany

Location

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Prof. Dr. Dr. Felix Balzer, MSc

  Charite University, Berlin, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. Dr. Felix Balzer, MSc; ECDF-Professor for

Study Record Dates

• First Submitted: January 27, 2020
• First Posted: February 24, 2020
• Study Start: October 15, 2019
• Primary Completion: January 1, 2021
• Study Completion: January 1, 2021
• Last Updated: September 8, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)