Postoperative ComplicationsNCT04281706
Impact of Etomidate vs. Propofol on Infectious Complications Post Cardiac Surgery
An observational study of Postoperative Complications, run by Charite University, Berlin, Germany at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Postoperative Complications
- What is being tested?
- Etomidate vs Propofol as induction agent
- How many people
- 1,495 participants
- Where
- 1 siteGermany
- Study dates
- 15 Oct 2019to 1 Jan 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Adult, Older adult
Study population: Patients that underwent cardiac surgery between October 1st, 2012 and January 31st, 2015
Who may be able to join
- ≥ 18 years of age
- Valve and/or coronary artery bypass graft surgery
Who cannot join
- Surgery during washout period (October 1st, 2013 - January 31st, 2014)
- Resurgery
- Endocarditis
- Known immunosuppression:
- Corticosteroid therapy
- Solid organ transplant
- Stem Cell therapy
- HIV diagnosis
Trial locations and contacts
1 site in 1 country.
Germany1 site
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
About this study
Official title: 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.
Read the 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
- Being tested
- Etomidate vs Propofol as induction agent
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Etomidate vs Propofol as induction agentDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Etomidate-Time-Frame | Patients that underwent cardiac surgery between October 1st, 2012 and September 30th, 2013 Receives: Drug: Etomidate vs Propofol as induction agent | |
| Propofol-Time-Frame | Patients that underwent cardiac surgery between February 1st, 2014 and January 31st, 2015 Receives: Drug: Etomidate vs Propofol as induction agent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sepsis
Incidence of sepsis according to diagnosis-related group coding between surgical intervention and hospital discharge (according to SEPSIS II)
Measured: surgical intervention to hospital discharge, average 30 days
Secondary outcomes (7)
Pneumonia
Incidence of pneumonia within between surgical intervention and hospital discharge
Measured: surgical intervention to hospital discharge, average 30 days
Mediastinitis
Incidence of mediastinitis within between surgical intervention and hospital discharge
Measured: surgical intervention to hospital discharge, average 30 days
Surgical Site Infections
Incidence of surgical site infections between surgical intervention and hospital discharge
Measured: surgical intervention to hospital discharge, average 30 days
ICU Mortality
Proportion of patients that died before ICU discharge
Measured: surgical intervention to ICU discharge, average 30 days
Hospital mortality
Proportion of patients that died before hospital discharge
Measured: surgical intervention to hospital discharge, average 30 days
Intensive Care Unit length of stay
Time patients spend on the ICU
Measured: ICU admission to ICU discharge, average 30 days
Hospital length of stay
Time patients spend admitted to the hospital
Measured: hospital admission to hospital discharge, average 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2020
- Study start15 Oct 2019
- Primary completion1 Jan 2021
- Study completion1 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative ComplicationsStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,495 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Felix Balzer, Charite University, Berlin, Germany
- Investigators
- Prof. Dr. Dr. Felix Balzer, MSc, Principal investigator, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04281706
- Sponsor's protocol ID
- EtoProp
- Status last verified
- Sep 2023
- First submitted
- 27 Jan 2020
- Last updated
- 8 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Etomidate vs. Propofol on Development of Sepsis and Infectious Complications Post Cardiac Surgery
- ClinicalTrials.gov ID
- NCT04281706
- Acronym / sponsor ID
- EtoProp
- Conditions
- Postoperative Complications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,495 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- 15 Oct 2019 (actual)
- Primary completion
- 1 Jan 2021 (actual)
- Study completion
- 1 Jan 2021 (actual)
- First posted
- 24 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Etomidate-Time-Frame | – | Drug: Etomidate vs Propofol as induction agentPatients that underwent cardiac surgery between October 1st, 2012 and September 30th, 2013 |
| Propofol-Time-Frame | – | Drug: Etomidate vs Propofol as induction agentPatients that underwent cardiac surgery between February 1st, 2014 and January 31st, 2015 |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients that underwent cardiac surgery between October 1st, 2012 and January 31st, 2015
Key inclusion criteria (2 listed)
- ≥ 18 years of age
- Valve and/or coronary artery bypass graft surgery
Key exclusion criteria (8 listed)
- Surgery during washout period (October 1st, 2013 - January 31st, 2014)
- Resurgery
- Endocarditis
- Known immunosuppression:
- Corticosteroid therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Etomidate vs Propofol as induction agentPatients 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. | Drug | Etomidate-Time-Frame, Propofol-Time-Frame |
Primary outcome
Sepsis
Time frame: surgical intervention to hospital discharge, average 30 days
Incidence of sepsis according to diagnosis-related group coding between surgical intervention and hospital discharge (according to SEPSIS II)
7 secondary outcomes
Pneumonia
Time frame: surgical intervention to hospital discharge, average 30 days
Mediastinitis
Time frame: surgical intervention to hospital discharge, average 30 days
Surgical Site Infections
Time frame: surgical intervention to hospital discharge, average 30 days
ICU Mortality
Time frame: surgical intervention to ICU discharge, average 30 days
Hospital mortality
Time frame: surgical intervention to hospital discharge, average 30 days
Intensive Care Unit length of stay
Time frame: ICU admission to ICU discharge, average 30 days
Hospital length of stay
Time frame: hospital admission to hospital discharge, average 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Prof. Dr. Dr. Felix Balzer, MSc principal investigator
Charite University, Berlin, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Complications, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sepsis (time frame: surgical intervention to hospital discharge, average 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2023.