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Completed

NCT Number: NCT05411315

Pragmatic Randomized Trial for Arterial Catheters in the Critical Care Environment

Investigators will conduct a pragmatic randomized trial to investigate the non-inferiority of restricted use of invasive arterial lines compared to standard arterial line use.

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Key information

Conditions

Mechanical Ventilation Complication Arterial Thrombosis Bloodstream Infection Cardiovascular Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hypotension Infections Inflammation Kidney Diseases Limb Ischemia Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Failure Renal Insufficiency Sepsis Shock Systemic Inflammatory Response Syndrome Urogenital Diseases Urologic Diseases Vascular Diseases Vasopressor Adverse Reaction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

About this study

Patients in the medical intensive care unit (MICU) often receive arterial lines as standard of care, however there are little data to support this practice. Investigators will randomly assign consecutive weeks to either current practice(control) or to a more conservative practice of not placing invasive arterial lines except for limited indication indications as defined below (intervention). Patients entering during an intervention week will be treated according to the intervention practice throughout their ICU stay. Likewise, patients entering during a control week will be treated according to current standard practice.

Permuted block randomization will be used to assure equal numbers of intervention and control weeks. All outcome measures will be obtained through EPIC data analytics and post-hospitalization phone calls. Weekly randomization codes will be generated by the study statisticians and delivered to MICU staff via sealed envelopes to be opened at the beginning of each week.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • All subjects admitted to the medical intensive care unit

Exclusion Criterion:

  • All subjects <18 years of age.

Treatment and study plan

Restricted-use of arterial catheter

Other

The investigator will restrict the use of arterial catheters unless exclusion criteria is met.

Standard-use of arterial catheter

Other

The investigator will allow standard-use of arterial catheters

Primary outcomes

  1. Number of days hospitalized in the medical intensive care unit (length-of-stay)

    Time frame: inpatient hospitalization (approximately 1 to 30 days)

    Number of days hospitalized in the medical intensive care unit

Secondary outcomes

  1. Number of days hospitalized in a non- medical intensive care unit (Hospital length-of-stay)

    Time frame: inpatient hospitalization (approximately 1 to 30 days)

    Number of days hospitalized in a non- medical intensive care unit

  2. Number of days using a mechanical ventilator (Ventilator-days)

    Time frame: inpatient hospitalization (approximately 1 to 30 days)

    Number of days spent on a mechanical ventilator

  3. Number of days using vasopressor medicines (vasopressor-days)

    Time frame: inpatient hospitalization (approximately 1 to 30 days)

    Number of days using vasopressor medicines

  4. Number of blood transfusions received during hospitalization (packed red blood cell transfusions)

    Time frame: inpatient hospitalization (approximately 1 to 30 days) and receiving approximately 0 - 10 blood transfusions

    Number of blood transfusions received during hospitalization

  5. Number of participants experiencing a bloodstream infection related to invasive arterial catheter use

    Time frame: inpatient hospitalization (approximately 1 to 30 days) and experiencing 0 to 1 bloodstream infections

    Number of participants experiencing a bloodstream infection related to invasive arterial catheter use

  6. Number of participants experiencing a vascular injury related to the invasive arterial catheter

    Time frame: inpatient hospitalization (approximately 1 to 30 days)

    vascular injuries include hematoma formation, ischemic limb, false aneurysm, limb injury

  7. Number of days subjects experiencing death within 28 days of medical intensive care unit while having received vasopressor medicines (28-day mortality while on vasopressors)

    Time frame: Inpatient or outpatient death within 1 to 28 days

    Number of days subjects experiencing death within 28 days of medical intensive care unit while having received vasopressor medicines

  8. Number of days subjects experiencing death within 28 days of medical intensive care unit from any cause (28-day all-cause mortality)

    Time frame: Inpatient or outpatient death within 1 to 28 days

    Number of days subjects experiencing death within 28 days of medical intensive care unit from any cause

  9. Number of days subjects experiencing death within 90 days of medical intensive care unit from any cause (90-day all-cause mortality)

    Time frame: Inpatient or outpatient death within 1 to 90 days

    The outcome of death that has occurred for subjects from all causes after 90 days

  10. Number of patients experiencing renal failure while hospitalized

    Time frame: inpatient hospitalization (approximately 1 to 30 days)

    Renal failure is defined as any renal replacement therapy

  11. Number of vasopressors used

    Time frame: Inpatient hospitalization (approximately 1 to 60 days)

    The quantity of vasopressors

  12. Number of ABG measurements

    Time frame: Inpatient hospitalization (approximately 1 to 60 days)

    The total quantity of ABG labs sent

Sponsors and collaborators

Lead sponsor

Dartmouth-Hitchcock Medical Center

Other

Registry information

Acronym: GRACE

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jun 9, 2022
Registry last updated
Feb 26, 2024

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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