NCT03939273

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

Randomized Placebo-controlled Study on the Effects of Antibiotic-induced Gut MicrobiomE Disruption on the Innate Immune Response Following Cardiac Surgery

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Radboud University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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

Detailed description

During cardiac surgery, the use of cardiopulmonary bypass and extracorporeal circulation, operative trauma, and ischemia-reperfusion injury can induce a profound systemic innate immune response. This response contributes to postoperative morbidity and mortality, as increased proinflammatory cytokine levels are associated with several postoperative complications. Commensal microbiota in the gut can modulate systemic immune responses. The investigators hypothesize that reduction of systemic immune activation by disruption of the microbiome may be beneficial in patients undergoing cardiac surgery. The objective of this trial is to assess the anti-inflammatory effects of disruption of the intestinal microbiota with broad-spectrum antibiotics in patients with systemic inflammation following cardiac surgery and to assess the effects on clinical outcomes in these patients. To this end, subjects will be randomized into one of two treatment arms and will receive either active treatment or a placebo during the seven days prior to surgery. Active treatment consists of a seven day course of oral ciprofloxacin 500 mg twice a day, oral vancomycin 500 mg thrice per day, oral metronidazole 500 mg thrice per day and a six day course of oral fluconazole 200 mg once per day. Placebo treatment is randomly allocated in a double blind fashion in a 1:1 proportion to the active treatment. Stool samples will be obtained prior to and directly after study treatment to assess the effects on the richness and diversity of the gut microbiota. During and after surgery, plasma levels of circulating cytokines will be measured to assess the effects of microbiota disruption on the inflammatory response.

Conditions

• Systemic Inflammatory Response Syndrome
• Postoperative Shock
• Coronary Artery Disease
• Extracorporeal Circulation; Complications

Interventions

Type	Name	Description
DRUG	Vancomycin Oral	500 mg thrice per day for seven days
DRUG	Metronidazole Oral	500 mg thrice per day for seven days
DRUG	Ciprofloxacin Pill	500 mg twice per day for seven days
DRUG	Fluconazole Oral Product	200 mg once per day for six days
DRUG	Placebos	seven day course of placebo tablets and capsules identical in appearance and number to active treatment

Timeline

• Start date: 2022-03-01
• Primary completion: 2023-03-01
• Completion: 2023-03-01
• First posted: 2019-05-06
• Last updated: 2021-03-12

Locations

1 site across 1 country: Netherlands