Pragmatic Randomized Trial for Arterial Catheters in the Critical Care Environment

NCT05411315 | Completed

• 1 other identifier: STUDY02001496
• Study Type: interventional
• Target: 700
• Locations: 1 country
• Sites: 1

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.

Conditions

Mechanical Ventilation Complication; Arterial Thrombosis; Limb Ischemia; Shock; Hypotension; Bloodstream Infection; Vasopressor Adverse Reaction; Renal Failure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• 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 using a mechanical ventilator (Ventilator-days)

  inpatient hospitalization (approximately 1 to 30 days)

• Number of days using vasopressor medicines (vasopressor-days)

  inpatient hospitalization (approximately 1 to 30 days)

• 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 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

Study Arms (2)

Restricted-use of arterial catheters

EXPERIMENTAL

Other: Restricted-use of arterial catheter

Standard-use of arterial catheters

ACTIVE COMPARATOR

Other: Standard-use of arterial catheter

Interventions

Restricted-use of arterial catheter OTHER

The investigator will restrict the use of arterial catheters unless exclusion criteria is met.

Restricted-use of arterial catheters

Standard-use of arterial catheter OTHER

The investigator will allow standard-use of arterial catheters

Standard-use of arterial catheters

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All subjects admitted to the medical intensive care unit
• All subjects \<18 years of age.

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead

Study Sites (1)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

MeSH Terms

Conditions

Shock; Hypotension; Sepsis; Renal Insufficiency

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• David Feller-Kopman, MD

  Dartmouth-Hitchcock Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine, Geisel School of Medicine Chief, Pulmonary and Critical Care Medicine

Model Details: Pragmatic randomized trial

Study Record Dates

• First Submitted: June 6, 2022
• First Posted: June 9, 2022
• Study Start: October 17, 2022
• Primary Completion: July 14, 2023
• Study Completion: July 14, 2023
• Last Updated: February 26, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)