Pragmatic Randomized Trial for Arterial Catheters in the Critical Care Environment (GRACE)

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Actual): 700
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Dartmouth-Hitchcock Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• All subjects admitted to the medical intensive care unit

Exclusion Criterion:

• All subjects <18 years of age.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
Number of days using a mechanical ventilator (Ventilator-days)	Number of days spent on a mechanical ventilator	inpatient hospitalization (approximately 1 to 30 days)
Number of days using vasopressor medicines (vasopressor-days)	Number of days using vasopressor medicines	inpatient hospitalization (approximately 1 to 30 days)
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
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
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)
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
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
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
Number of patients experiencing renal failure while hospitalized	Renal failure is defined as any renal replacement therapy	inpatient hospitalization (approximately 1 to 30 days)
Number of vasopressors used	The quantity of vasopressors	Inpatient hospitalization (approximately 1 to 60 days)
Number of ABG measurements	The total quantity of ABG labs sent	Inpatient hospitalization (approximately 1 to 60 days)

Collaborators and Investigators

• Sponsor: Dartmouth-Hitchcock Medical Center
• Investigators: Principal Investigator: David Feller-Kopman, MD, Dartmouth-Hitchcock Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): October 17, 2022
• Primary Completion (Actual): July 14, 2023
• Study Completion (Actual): July 14, 2023

Study Registration Dates

• First Submitted: June 6, 2022
• First Submitted That Met QC Criteria: June 6, 2022
• First Posted (Actual): June 9, 2022

Study Record Updates

• Last Update Posted (Estimated): February 26, 2024
• Last Update Submitted That Met QC Criteria: February 22, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Embolism and Thrombosis; Sepsis; Ischemia; Thrombosis; Hypotension
• Other Study ID Numbers: STUDY02001496

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No