Selective Decontamination of the Digestive Tract in Intensive Care Unit Patients

Summary

Introduction- Hospital acquired infections (HAI) are a major cause of morbidity and mortality and increase health care costs. Critically ill patients are particularly susceptible to these infections and have an even higher mortality. One intervention that has gained much interest in the medical literature for reducing infection rates and deaths from HAIs is selective decontamination of the digestive tract (SDD). SDD involves the application of antibiotic paste to the mouth, throat, stomach and a short course of intravenous antibiotics. The evidence supporting the use of SDD for saving lives and preventing infections is actually quite strong. However, health care professionals in many parts of the world have refrained from using SDD due to fears of the effects of overuse of antibiotics on the frequency of infections with resistant bacteria such as multi-resistant Gram negative organisms, MRSA and Clostridium difficile.

SuDDICU is a cross-over, cluster randomised trial comparing the effect of using selective decontamination of the digestive tract (SDD) plus standard care, to standard care alone on hospital mortality in patients receiving mechanical ventilation in the intensive care unit (ICU).

Secondary outcomes include an ecological assessment and a long-term health economic analysis.

Conditions

• Critical Illness
• Sepsis
• Septic Shock
• Ventilator Associated Pneumonia

Interventions

DRUG

SDD Oral Paste

A six-hourly topical application of 0.5g paste, containing colistin 10mg, tobramycin 10mg and nystatin 125,000 IU, to the buccal mucosa and oropharynx

DRUG

SDD Gastric Suspension

2\. A six-hourly administration of 10 mL of a suspension containing 100 mg colistin, 80 mg tobramycin and 2 x 10 \^6 IU nystatin, to the gastrointestinal tract via a gastric/post-pyloric tube

DRUG

Intravenous Antibiotic

A four-day course of an intravenous antibiotic in patients not already receiving a therapeutic antibiotic

Sponsors & Collaborators

• Imperial College London

  collaborator OTHER

• Sunnybrook Health Sciences Centre

  collaborator OTHER

• The George Institute

  lead OTHER

Principal Investigators

• John Myburgh, MBBCh PhD · The George Institute

• Brian Cuthbertson, MD FRCA · Sunnybrook Health Sciences Centre

• Anthony Gordon, MD FRCA · Imperial College London

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

CROSSOVER

Eligibility

Min Age

16 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-05-01

Primary Completion

2023-04-26

Completion

2023-04-26

Countries

• Australia
• Canada
• United Kingdom

Study Locations