Pragmatic Randomized Trial for Arterial Catheters in the Critical Care Environment

Hypotension Clinical Trial

— GRACE  

Official title:

Pragmatic Randomized Trial for Arterial Catheters in the Critical Care Environment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05411315
• Other study ID #: STUDY02001496
• Status: Completed
• Phase: N/A
• Start date: October 17, 2022
• Est. completion date: July 14, 2023

Study information

• Verified date: February 2024
• Source: Dartmouth-Hitchcock Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Arterial Thrombosis
• Bloodstream Infection
• Hypotension
• Ischemia
• Limb Ischemia
• Mechanical Ventilation Complication
• Renal Failure
• Sepsis
• Shock
• Thrombosis

Intervention

Other:
• Restricted-use of arterial catheter
The investigator will restrict the use of arterial catheters unless exclusion criteria is met.
• Standard-use of arterial catheter
The investigator will allow standard-use of arterial catheters

Locations

Country	Name	City	State
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire

Sponsors (1)

Lead Sponsor	Collaborator
Dartmouth-Hitchcock Medical Center

Country where clinical trial is conducted

United States, 

Outcome

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)