The Effects of Gut Micribiota Disruption on the Immune Response After Open Heart Surgery (NCT03939273) | Clinical Trial Compass
UnknownNot Applicable
The Effects of Gut Micribiota Disruption on the Immune Response After Open Heart Surgery
Netherlands80 participantsStarted 2022-03
Plain-language summary
In this randomized, double-blind, placebo-controlled study, the investigators will assess whether preoperative disruption of the gut microbiota by a course of broad spectrum antibiotics will attenuate the postoperative systemic inflammatory response after on-pump cardiac surgery
Who can participate
Age range
18 Years – 99 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age \> 18 years
* Scheduled for elective on-pump cardiac surgery.
* Written informed consent to participate in this trial prior to any study-mandated procedure
Exclusion Criteria:
* Use of any antibiotic or antifungal therapies within 30 days prior to surgery
* History of inflammatory bowel disease
* History of bowel resection and / or short bowel syndrome
* Pre-operative creatinine clearance \< 50 ml/min
* Severe hepatic impairment
* Immune compromised
* Solid organ transplantation
* Known HIV
* Pregnancy
* Use of immunosuppressive drugs
* Emergency surgery
* Haematological disorders
* Disorders from myeloid and / or lymphoid origin
* Leucopenia
* Known hypersensitivity to any of the investigational and/or non-investigational products or their excipients.
* Treatment with investigational drugs or participation in any other intervention clinical trial within 30 days prior to study drug administration
* Inability to personally provide written informed consent
* Suspected of not being able to comply with the trial protocol
* Use of vitamin K antagonists
* Use of tricyclic antidepressants
* Use of other drugs which have potential dangerous interactions with study treatment
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Between group differences in Area Under the Curve (AUC) of the time-concentration curve of interleukin (IL)-6 plasma concentrations.
Timeframe: During surgery and up to 24 hours after surgery