Pragmatic Randomized Trial for Arterial Catheters in the Critical Care Environment

Not Applicable

Completed

• Conditions: Arterial Thrombosis; Limb Ischemia; Shock; Mechanical Ventilation Complication; Hypotension; Vasopressor Adverse Reaction; Renal Failure; Bloodstream Infection
• Interventions: Other: Restricted-use of arterial catheter; Other: Standard-use of arterial catheter

• Registration Number: NCT05411315
• Lead Sponsor: Dartmouth-Hitchcock Medical Center

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.

Study Timeline

• Study First Submitted: 2022-06-06
• Study First Submitted QC: 2022-06-06
• Study First Posted: 2022-06-09
• Study Start: 2022-10-17
• Primary Completion: 2023-07-14
• Study Completion: 2023-07-14
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-22
• Last Update Posted: 2024-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 700

Inclusion Criteria

• All subjects admitted to the medical intensive care unit

Exclusion Criterion:

• All subjects <18 years of age.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Restricted-use of arterial catheters	Restricted-use of arterial catheter	-
Standard-use of arterial catheters	Standard-use of arterial catheter	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Number of vasopressors used	Inpatient hospitalization (approximately 1 to 60 days)	The quantity of vasopressors
Number of days using vasopressor medicines (vasopressor-days)	inpatient hospitalization (approximately 1 to 30 days)	Number of days using vasopressor medicines
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 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 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 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 ABG measurements	Inpatient hospitalization (approximately 1 to 60 days)	The total quantity of ABG labs sent
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 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 patients experiencing renal failure while hospitalized	inpatient hospitalization (approximately 1 to 30 days)	Renal failure is defined as any renal replacement therapy

Trial Locations

Locations (1)

Dartmouth-Hitchcock Medical Center; 🇺🇸 Lebanon, New Hampshire, United States