Arterial Thrombosis, Bloodstream Infection, Hypotension, Limb Ischemia, Mechanical Ventilation Complication, Renal Failure, Shock, Vasopressor Adverse Reaction
Conditions
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.
Interventions
OTHERRestricted-use of arterial catheter
The investigator will restrict the use of arterial catheters unless exclusion criteria is met.
OTHERStandard-use of arterial catheter
The investigator will allow standard-use of arterial catheters
Sponsors
Dartmouth-Hitchcock Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Pragmatic randomized trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* All subjects admitted to the medical intensive care unit Exclusion Criterion: * All subjects \<18 years of age.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of days hospitalized in the medical intensive care unit (length-of-stay) | inpatient hospitalization (approximately 1 to 30 days) | Number of days hospitalized in the medical intensive care unit |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of days using a mechanical ventilator (Ventilator-days) | inpatient hospitalization (approximately 1 to 30 days) | Number of days spent on a mechanical ventilator |
| Number of days using vasopressor medicines (vasopressor-days) | inpatient hospitalization (approximately 1 to 30 days) | Number of days using vasopressor medicines |
| Number of blood transfusions received during hospitalization (packed red blood cell transfusions) | inpatient hospitalization (approximately 1 to 30 days) and receiving approximately 0 - 10 blood transfusions | Number of blood transfusions received during hospitalization |
| Number of participants experiencing a bloodstream infection related to invasive arterial catheter use | 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 |
| Number of participants experiencing a vascular injury related to the invasive arterial catheter | inpatient hospitalization (approximately 1 to 30 days) | vascular injuries include hematoma formation, ischemic limb, false aneurysm, limb injury |
| Number of days hospitalized in a non- medical intensive care unit (Hospital length-of-stay) | inpatient hospitalization (approximately 1 to 30 days) | Number of days hospitalized in a non- medical intensive care unit |
| Number of days subjects experiencing death within 28 days of medical intensive care unit from any cause (28-day all-cause mortality) | 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 |
| Number of days subjects experiencing death within 90 days of medical intensive care unit from any cause (90-day all-cause mortality) | Inpatient or outpatient death within 1 to 90 days | The outcome of death that has occurred for subjects from all causes after 90 days |
| Number of patients experiencing renal failure while hospitalized | inpatient hospitalization (approximately 1 to 30 days) | Renal failure is defined as any renal replacement therapy |
| Number of vasopressors used | Inpatient hospitalization (approximately 1 to 60 days) | The quantity of vasopressors |
| Number of ABG measurements | Inpatient hospitalization (approximately 1 to 60 days) | The total quantity of ABG labs sent |
| 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) | 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 |
Countries
United States
Outcome results
None listed