VasoplegiaNCT05925348
Endotoxinemia and Vasoplegia Following Cardiothoracic Surgery With Cardiopulmonary Bypass (CPB)
An observational study of Vasoplegia and Vasoplegic Shock, run by Universität Münster at 1 site in Germany.
Trial summary
This observational study investigates the effect of endotoxinemia on the postoperative incidence of vasoplegia or vasoplegic shock in patients undergoing cardiac surgery with the use of cardiopulmonary bypass. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vasoplegia, Vasoplegic Shock
- What is being tested?
- Patients with cardiopulmonary bypass
- How many people
- 200 participants
- Where
- 1 siteGermany
- Study dates
- 2 Oct 2023to Jan 2025
- 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 years and older
- All sexes
- Adult, Older adult
Study population: Perioperative patients
Who may be able to join
- adult patients undergoing cardiac surgery requiring CPB
- written informed consent
Who cannot join
- emergency surgery in the context of acute coronary syndrome
- patients with chronic inflammatory diseases of the gut
- patients receiving immunosuppressive drugs
- patients with infectious endocarditis
- patients with sepsis
- patients with chronic kidney disease with estimated glomerular filtration rate (eGFR) <20 ml/min/1,73m²
- persons with any kind of dependency on the investigator or employed by the institution responsible or investigator
- persons held in an institution by legal of official order -
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University Hospital Münster
Münster, 48149
About this study
Official title: Effect of Endotoxinemia on the Incidence of Postoperative Vasoplegia or Vasoplegic Shock Following Cardiothoracic Surgery Using Cardiopulmonary Bypass
This observational study investigates the effect of endotoxinemia on the postoperative incidence of vasoplegia or vasoplegic shock in patients undergoing cardiac surgery with the use of cardiopulmonary bypass.
Read the detailed description
Through previous research, it has been well established that cardiothoracic surgery using cardiopulmonary bypass (CPB) causes a systemic inflammatory response. This is in part due to the surgical trauma, the extracorporeal circulation and factors that come with it (e.g. blood contact with foreign surfaces, mechanical stress etc.), and ischemia. This inflammatory response is a key contributor to the incidence of vasoplegia and vasoplegic shock following these types of surgery - a common complication that in turn causes significant morbidity and mortality. Over the years, many factors that contribute to this reaction have been discussed. One potential explanation is the release of endotoxin into the bloodstream during CPB. Endotoxin is a molecule that is a part of bacteria which are native to the human gut. In healthy subjects, cell-barriers prevent release of relevant amounts of endotoxin into the blood stream. During major interventions, and especially during cardiac surgery with CPB, this barrier function is impeded, allowing endotoxin levels to rise and potentially exert detrimental effects. While previous studies have indicated that endotoxin may in fact be released into the bloodstream in significant concentrations, and there are some mechanistic explanations to how endotoxin may contribute to the resulting inflammation and vasoplegia, available studies have been small and the evidence is inconclusive. This study aims to show whether different blood-levels of endotoxin are associated with vasoplegia and vasoplegic shock in patients undergoing cardiac surgery with CPB.
- Conditions
- Vasoplegia, Vasoplegic Shock
- Being tested
- Patients with cardiopulmonary bypass
- Keywords
- Endotoxin, cardiopulmonary bypass (CBP), Vasoplegia, Vasoplegic shock
- Medical subject headings
- Vasoplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients with cardiopulmonary bypassDiagnostic test
Due to the observational design of the study, no study-specific interventions are performed.
Blood samples are measured to analyze blood-levels of endotoxin
What is being measured
The primary outcome is the main question the study is designed to answer.
Norepinephrine equivalent dose (NED)
Measured: within 24 hours following induction of general anesthesia
Secondary outcomes (4)
Fluid input
Measured: within 24 hours following induction of general anesthesia
Fluid balance
Measured: within 24 hours following induction of general anesthesia
Occurence of Acute Kidney Injury (AKI) according to the Kidney Disease: Improving Global Outcomes (KDIGO) criteria
Measured: 72 hours after cardiac surgery
Duration of mechanical ventilation
Measured: within 72 hours after cardiac surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2023
- Study start2 Oct 2023
- Primary completionDec 2024 (estimated)
- Study completionJan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VasoplegiaStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universität Münster
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexander Zarbock, MD, Study chair, University Hospital Muenster, Dept. of Anesthesiology, Intensive Care Therapy and Pain Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05925348
- Sponsor's protocol ID
- AnIt22-11
- Status last verified
- Nov 2023
- First submitted
- 20 Jun 2023
- Last updated
- 11 Dec 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 11 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Endotoxinemia on the Incidence of Postoperative Vasoplegia or Vasoplegic Shock Following Cardiothoracic Surgery Using Cardiopulmonary Bypass
- ClinicalTrials.gov ID
- NCT05925348
- Acronym / sponsor ID
- AnIt22-11
- Conditions
- Vasoplegia, Vasoplegic Shock
- Keywords
- Endotoxin, cardiopulmonary bypass (CBP), Vasoplegia, Vasoplegic shock
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Universität MünsterUniversity, hospital or other
- Study start
- 2 Oct 2023 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 29 Jun 2023 (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.
This observational study investigates the effect of endotoxinemia on the postoperative incidence of vasoplegia or vasoplegic shock in patients undergoing cardiac surgery with the use of cardiopulmonary bypass.
Detailed description
Through previous research, it has been well established that cardiothoracic surgery using cardiopulmonary bypass (CPB) causes a systemic inflammatory response. This is in part due to the surgical trauma, the extracorporeal circulation and factors that come with it (e.g. blood contact with foreign surfaces, mechanical stress etc.), and ischemia. This inflammatory response is a key contributor to the incidence of vasoplegia and vasoplegic shock following these types of surgery - a common complication that in turn causes significant morbidity and mortality. Over the years, many factors that contribute to this reaction have been discussed. One potential explanation is the release of endotoxin into the bloodstream during CPB. Endotoxin is a molecule that is a part of bacteria which are native to the human gut. In healthy subjects, cell-barriers prevent release of relevant amounts of endotoxin into the blood stream. During major interventions, and especially during cardiac surgery with CPB, this barrier function is impeded, allowing endotoxin levels to rise and potentially exert detrimental effects. While previous studies have indicated that endotoxin may in fact be released into the bloodstream in significant concentrations, and there are some mechanistic explanations to how endotoxin may contribute to the resulting inflammation and vasoplegia, available studies have been small and the evidence is inconclusive. This study aims to show whether different blood-levels of endotoxin are associated with vasoplegia and vasoplegic shock in patients undergoing cardiac surgery with CPB.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Perioperative patients
Key inclusion criteria (2 listed)
- adult patients undergoing cardiac surgery requiring CPB
- written informed consent
Key exclusion criteria (8 listed)
- emergency surgery in the context of acute coronary syndrome
- patients with chronic inflammatory diseases of the gut
- patients receiving immunosuppressive drugs
- patients with infectious endocarditis
- patients with sepsis
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 |
|---|---|---|
| Patients with cardiopulmonary bypassDue to the observational design of the study, no study-specific interventions are performed. Blood samples are measured to analyze blood-levels of endotoxin | Diagnostic test | – |
Primary outcome
Norepinephrine equivalent dose (NED)
Time frame: within 24 hours following induction of general anesthesia
4 secondary outcomes
Fluid input
Time frame: within 24 hours following induction of general anesthesia
Fluid balance
Time frame: within 24 hours following induction of general anesthesia
Occurence of Acute Kidney Injury (AKI) according to the Kidney Disease: Improving Global Outcomes (KDIGO) criteria
Time frame: 72 hours after cardiac surgery
Duration of mechanical ventilation
Time frame: within 72 hours after cardiac surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 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.
Alexander Zarbock, MD study chair
University Hospital Muenster, Dept. of Anesthesiology, Intensive Care Therapy and Pain Medicine
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 Vasoplegia and Vasoplegic Shock, run by Universität Münster 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: status not confirmed, as of the sponsor's last update on 11 Dec 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sadjadi, MD (+49-251-8347255, aki@anit.uni-muenster.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Norepinephrine equivalent dose (NED) (time frame: within 24 hours following induction of general anesthesia). 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 11 Dec 2023.