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Completed

NCT Number: NCT03868241

Coated Devices to Decrease Infection in the Intensive Care Unit

Pilot explanatory, randomized, open label, controlled trial. Critically ill patients which will demand placement of invasive devices for organ support (endotracheal tube, central venous catheter and urinary Foley catheter) will be randomized 1:1 to receive coated (Bactiguard®) or habitual (non-coated) devices.

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Key information

Conditions

Critically Ill Critical Illness Cross Infection Disease Attributes Healthcare-Associated Pneumonia Iatrogenic Disease Infections Inflammation Lung Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Ventilator-Associated Respiratory Tract Diseases Respiratory Tract Infections Sepsis Systemic Inflammatory Response Syndrome

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Hospital de Base de São José do Rio Preto, Rio Preto, São Paulo, Brazil

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All patients admitted to the intensive care unit which will require simultaneous insertion of all three devices (endotracheal tube, central venous catheter and urinary catheter) due to illness severity as defined by the attending physician.

Exclusion criteria

  • Patients admitted to the intensive care unit for more than 48 hours or admitted in the hospital for more than seven days
  • Presence of any of the invasive devices (endotracheal tube, central venous catheter or urinary catheters) before randomization and absence of the intention to exchange the devices;
  • Previous use of any type of coated devices;
  • Age < 18 years;
  • Known pregnancy
  • Known allergy to gold, silver and palladium;
  • Suspected or confirmed brain death;
  • Previously enrolled in the study

Newly added exclusion criteria in version 2.0:

  • Severe chronic pulmonary obstructive disease which may limit catheter site selection
  • Previous irradiation and/or thrombosis in site selected for catheter insertion

Treatment and study plan

Coated devices

Device

Gold-silver-palladium coated devices (endotracheal tube, central venous catheter and urinary catheter) will be used whenever necessary. All three devices are required to be inserted as soon as possible after randomization and need for all three devices are the main inclusion criteria

Control

Device

Devices without coating available at each participating intensive care unit

Primary outcomes

  1. Number of participants recruited in each center during the trial

    Time frame: Through study completion, an average of 1 year

    Assess the recruitment rate

  2. Number of participants admitted to the intensive care unit that requires simultaneous insertion of endotracheal tube, central venous catheter and urinary catheter

    Time frame: Through study completion, an average of 1 year

    Assess how many patients admitted to the intensive care unit will demand insertion of endotracheal tube, urinary catheter and central venous catheter after admission in all patients

  3. Feasibility - Occurence of sepsis

    Time frame: 28 days

    Occurrence of sepsis after admission in patients that require all three devices to be inserted in all patients

Secondary outcomes

  1. Sepsis

    Time frame: 28 days

    Occurrence of sepsis after randomization (defined as infection plus organ failure)

  2. Occurence of ventilator-associated pneumonia

    Time frame: 28 days

    Occurence of ventilator-associated pneumonia by radiographic and clinical criteria

  3. Occurence of central venous catheter-related bloodstream infection

    Time frame: 28 days

    Occurence of central venous catheter-related bloodstream infection using Brazilian regulatory agency criteria

  4. Occurence of urinary catheter-related infection

    Time frame: 28 days

    Occurence of urinary catheter-related infection defined as positive urinary culture coupled with fever and without any other infection source

  5. Rate of composite endpoint of ventilator-associated pneumonia and/or central venous catheter-related bloodstream infection and/or urinary catheter-related infection

    Time frame: 28 days

    Occurrence of any of the infections above

  6. Antibiotic-free days

    Time frame: 28 days

    Number of days not receiving antibiotics

  7. Number of patients that die in Intensive Care Unit

    Time frame: Through intensive care unit stay, an average of 28 days

    Mortality during intensive care unit stay

  8. Number of patients that die during hospital stay

    Time frame: Through hospital stay, an average of 40 days

    Mortality during hospital stay

Sponsors and collaborators

Lead sponsor

Hospital do Coracao

Other

Collaborators

  • Bactiguard AB

Registry information

Official study title

Randomized Controlled Open-label Trial Assessing the Efficacy of a Bundle of Coated Devices to Reduce Nosocomial Infections in the Intensive Care Unit

Acronym: CRITIC

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Mar 11, 2019
Registry last updated
Mar 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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