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

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Dartmouth Health

Status

Completed

Conditions

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

Treatments

Other: Standard-use of arterial catheter
Other: Restricted-use of arterial catheter

Study type

Interventional

Funder types

Other

Identifiers

NCT05411315
STUDY02001496

Details and patient eligibility

About

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.

Full 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.

Enrollment

700 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

  • All subjects admitted to the medical intensive care unit

Exclusion Criterion:

  • All subjects <18 years of age.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

700 participants in 2 patient groups

Restricted-use of arterial catheters
Experimental group
Treatment:
Other: Restricted-use of arterial catheter
Standard-use of arterial catheters
Active Comparator group
Treatment:
Other: Standard-use of arterial catheter

Trial contacts and locations

1

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Central trial contact

Terrence Wong, MD; David Feller-Kopman, MD

Data sourced from clinicaltrials.gov

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