Clinical trial NCT05411315: Pragmatic Randomized Trial for Arterial Catheters in the Critical Care Environment
Official title: Pragmatic Randomized Trial for Arterial Catheters in the Critical Care Environment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mechanical Ventilation Complication
Arterial Thrombosis
Limb Ischemia
Shock
Hypotension
Bloodstream Infection
Vasopressor Adverse Reaction
Renal Failure
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
First posted: 2022-06-09
Enrollment: 700
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pragmatic randomized trial
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* All subjects admitted to the medical intensive care unit

Exclusion Criterion:

* All subjects \<18 years of age.

Primary outcomes:
measure: Number of days hospitalized in the medical intensive care unit (length-of-stay)
timeFrame: inpatient hospitalization (approximately 1 to 30 days)
Secondary outcomes:
measure: Number of days hospitalized in a non- medical intensive care unit (Hospital length-of-stay)
timeFrame: inpatient hospitalization (approximately 1 to 30 days)
measure: Number of days using a mechanical ventilator (Ventilator-days)
timeFrame: inpatient hospitalization (approximately 1 to 30 days)
measure: Number of days using vasopressor medicines (vasopressor-days)
timeFrame: inpatient hospitalization (approximately 1 to 30 days)
measure: Number of blood transfusions received during hospitalization (packed red blood cell transfusions)
timeFrame: inpatient hospitalization (approximately 1 to 30 days) and receiving approximately 0 - 10 blood transfusions
measure: Number of participants experiencing a bloodstream infection related to invasive arterial catheter use
timeFrame: inpatient hospitalization (approximately 1 to 30 days) and experiencing 0 to 1 bloodstream infections
measure: Number of participants experiencing a vascular injury related to the invasive arterial catheter
timeFrame: inpatient hospitalization (approximately 1 to 30 days)
measure: 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)
timeFrame: Inpatient or outpatient death within 1 to 28 days
measure: Number of days subjects experiencing death within 28 days of medical intensive care unit from any cause (28-day all-cause mortality)
timeFrame: Inpatient or outpatient death within 1 to 28 days
measure: Number of days subjects experiencing death within 90 days of medical intensive care unit from any cause (90-day all-cause mortality)
timeFrame: Inpatient or outpatient death within 1 to 90 days
measure: Number of patients experiencing renal failure while hospitalized
timeFrame: inpatient hospitalization (approximately 1 to 30 days)
measure: Number of vasopressors used
timeFrame: Inpatient hospitalization (approximately 1 to 60 days)
measure: Number of ABG measurements
timeFrame: Inpatient hospitalization (approximately 1 to 60 days)
Other outcomes:
Locations:
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
Study officials:
affiliation: Dartmouth-Hitchcock Medical Center
name: David Feller-Kopman, MD
role: PRINCIPAL_INVESTIGATOR
References: