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

NCT03939273 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2021-03-12

No results posted yet for this study

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

Conditions

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

Interventions

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

Sponsors & Collaborators

  • Radboud University Medical Center

    lead OTHER

Principal Investigators

  • Peter Pickkers, MD, PhD · Radboud University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-31
Primary Completion
2023-03-31
Completion
2023-03-31

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03939273 on ClinicalTrials.gov