GRACE: Pragmatic Randomized Trial for Arterial Catheters in the Critical Care Environment
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Restricted-use of arterial catheters
|
Other: Restricted-use of arterial catheter
The investigator will restrict the use of arterial catheters unless exclusion criteria is met.
|
| Active Comparator: Standard-use of arterial catheters
|
Other: Standard-use of arterial catheter
The investigator will allow standard-use of arterial catheters
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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 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 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
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
- All subjects admitted to the medical intensive care unit
Exclusion Criteria:
-
Clinical discretion of the attending physician
-
Severe pulmonary hypertension (right ventricular systolic pressure > 60 mmHg)
-
Unreliable pulse oximetry
-
Unreliable non-invasive blood pressure monitoring
-
Absolute need of arterial blood gas measurement after 5 consecutive failed arterial blood gas sticks
-
Extracorporeal membrane oxygenation
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Dartmouth-Hitchcock Medical Center
Investigators
- Principal Investigator: David Feller-Kopman, MD, Dartmouth-Hitchcock Medical Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- STUDY02001496