Hypotension Clinical Trial
— GRACEOfficial title:
Pragmatic Randomized Trial for Arterial Catheters in the Critical Care Environment
Verified date | February 2024 |
Source | Dartmouth-Hitchcock Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 700 |
Est. completion date | July 14, 2023 |
Est. primary completion date | July 14, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - All subjects admitted to the medical intensive care unit Exclusion Criterion: - All subjects <18 years of age. |
Country | Name | City | State |
---|---|---|---|
United States | Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire |
Lead Sponsor | Collaborator |
---|---|
Dartmouth-Hitchcock Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of days hospitalized in the medical intensive care unit (length-of-stay) | Number of days hospitalized in the medical intensive care unit | inpatient hospitalization (approximately 1 to 30 days) | |
Secondary | Number of days hospitalized in a non- medical intensive care unit (Hospital length-of-stay) | Number of days hospitalized in a non- medical intensive care unit | inpatient hospitalization (approximately 1 to 30 days) | |
Secondary | Number of days using a mechanical ventilator (Ventilator-days) | Number of days spent on a mechanical ventilator | inpatient hospitalization (approximately 1 to 30 days) | |
Secondary | Number of days using vasopressor medicines (vasopressor-days) | Number of days using vasopressor medicines | inpatient hospitalization (approximately 1 to 30 days) | |
Secondary | Number of blood transfusions received during hospitalization (packed red blood cell transfusions) | Number of blood transfusions received during hospitalization | inpatient hospitalization (approximately 1 to 30 days) and receiving approximately 0 - 10 blood transfusions | |
Secondary | Number of participants experiencing a bloodstream infection related to invasive arterial catheter use | 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 | |
Secondary | Number of participants experiencing a vascular injury related to the invasive arterial catheter | vascular injuries include hematoma formation, ischemic limb, false aneurysm, limb injury | inpatient hospitalization (approximately 1 to 30 days) | |
Secondary | 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) | Number of days subjects experiencing death within 28 days of medical intensive care unit while having received vasopressor medicines | Inpatient or outpatient death within 1 to 28 days | |
Secondary | Number of days subjects experiencing death within 28 days of medical intensive care unit from any cause (28-day all-cause mortality) | Number of days subjects experiencing death within 28 days of medical intensive care unit from any cause | Inpatient or outpatient death within 1 to 28 days | |
Secondary | Number of days subjects experiencing death within 90 days of medical intensive care unit from any cause (90-day all-cause mortality) | The outcome of death that has occurred for subjects from all causes after 90 days | Inpatient or outpatient death within 1 to 90 days | |
Secondary | Number of patients experiencing renal failure while hospitalized | Renal failure is defined as any renal replacement therapy | inpatient hospitalization (approximately 1 to 30 days) | |
Secondary | Number of vasopressors used | The quantity of vasopressors | Inpatient hospitalization (approximately 1 to 60 days) | |
Secondary | Number of ABG measurements | The total quantity of ABG labs sent | Inpatient hospitalization (approximately 1 to 60 days) |
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