The Effects of Gut Micribiota Disruption on the Immune Response After Open Heart Surgery

• Status: Not yet recruiting
• Trial end date: 2023-03-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Radboud University
• Treatments: Ciprofloxacin; Fluconazole; Metronidazole; Vancomycin

Criteria

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