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

Primary Purpose

Mechanical Ventilation Complication, Arterial Thrombosis, Limb Ischemia

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Restricted-use of arterial catheter
Standard-use of arterial catheter
Sponsored by
Dartmouth-Hitchcock Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Mechanical Ventilation Complication

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • All subjects admitted to the medical intensive care unit

Exclusion Criteria:

  • Clinical discretion of the attending physician
  • Severe pulmonary hypertension (right ventricular systolic pressure > 60 mmHg)
  • Unreliable pulse oximetry
  • Unreliable non-invasive blood pressure monitoring
  • Absolute need of arterial blood gas measurement after 5 consecutive failed arterial blood gas sticks
  • Extracorporeal membrane oxygenation

Sites / Locations

  • Dartmouth-Hitchcock Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Restricted-use of arterial catheters

Standard-use of arterial catheters

Arm Description

Outcomes

Primary Outcome Measures

Number of days hospitalized in the medical intensive care unit (length-of-stay)
Number of days hospitalized in the medical intensive care unit

Secondary Outcome Measures

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
Number of days using a mechanical ventilator (Ventilator-days)
Number of days spent on a mechanical ventilator
Number of days using vasopressor medicines (vasopressor-days)
Number of days using vasopressor medicines
Number of blood transfusions received during hospitalization (packed red blood cell transfusions)
Number of blood transfusions received during hospitalization
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
Number of participants experiencing a vascular injury related to the invasive arterial catheter
vascular injuries include hematoma formation, ischemic limb, false aneurysm, limb injury
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
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
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
Number of patients experiencing renal failure while hospitalized
Renal failure is defined as any renal replacement therapy

Full Information

First Posted
June 6, 2022
Last Updated
February 13, 2023
Sponsor
Dartmouth-Hitchcock Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT05411315
Brief Title
Pragmatic Randomized Trial for Arterial Catheters in the Critical Care Environment
Acronym
GRACE
Official Title
Pragmatic Randomized Trial for Arterial Catheters in the Critical Care Environment
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 17, 2022 (Actual)
Primary Completion Date
January 15, 2024 (Anticipated)
Study Completion Date
January 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dartmouth-Hitchcock Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mechanical Ventilation Complication, Arterial Thrombosis, Limb Ischemia, Shock, Hypotension, Bloodstream Infection, Vasopressor Adverse Reaction, Renal Failure

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Pragmatic randomized trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
456 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Restricted-use of arterial catheters
Arm Type
Experimental
Arm Title
Standard-use of arterial catheters
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Restricted-use of arterial catheter
Intervention Description
The investigator will restrict the use of arterial catheters unless exclusion criteria is met.
Intervention Type
Other
Intervention Name(s)
Standard-use of arterial catheter
Intervention Description
The investigator will allow standard-use of arterial catheters
Primary Outcome Measure Information:
Title
Number of days hospitalized in the medical intensive care unit (length-of-stay)
Description
Number of days hospitalized in the medical intensive care unit
Time Frame
inpatient hospitalization (approximately 1 to 30 days)
Secondary Outcome Measure Information:
Title
Number of days hospitalized in a non- medical intensive care unit (Hospital length-of-stay)
Description
Number of days hospitalized in a non- medical intensive care unit
Time Frame
inpatient hospitalization (approximately 1 to 30 days)
Title
Number of days using a mechanical ventilator (Ventilator-days)
Description
Number of days spent on a mechanical ventilator
Time Frame
inpatient hospitalization (approximately 1 to 30 days)
Title
Number of days using vasopressor medicines (vasopressor-days)
Description
Number of days using vasopressor medicines
Time Frame
inpatient hospitalization (approximately 1 to 30 days)
Title
Number of blood transfusions received during hospitalization (packed red blood cell transfusions)
Description
Number of blood transfusions received during hospitalization
Time Frame
inpatient hospitalization (approximately 1 to 30 days) and receiving approximately 0 - 10 blood transfusions
Title
Number of participants experiencing a bloodstream infection related to invasive arterial catheter use
Description
Number of participants experiencing a bloodstream infection related to invasive arterial catheter use
Time Frame
inpatient hospitalization (approximately 1 to 30 days) and experiencing 0 to 1 bloodstream infections
Title
Number of participants experiencing a vascular injury related to the invasive arterial catheter
Description
vascular injuries include hematoma formation, ischemic limb, false aneurysm, limb injury
Time Frame
inpatient hospitalization (approximately 1 to 30 days)
Title
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)
Description
Number of days subjects experiencing death within 28 days of medical intensive care unit while having received vasopressor medicines
Time Frame
Inpatient or outpatient death within 1 to 28 days
Title
Number of days subjects experiencing death within 28 days of medical intensive care unit from any cause (28-day all-cause mortality)
Description
Number of days subjects experiencing death within 28 days of medical intensive care unit from any cause
Time Frame
Inpatient or outpatient death within 1 to 28 days
Title
Number of days subjects experiencing death within 90 days of medical intensive care unit from any cause (90-day all-cause mortality)
Description
The outcome of death that has occurred for subjects from all causes after 90 days
Time Frame
Inpatient or outpatient death within 1 to 90 days
Title
Number of patients experiencing renal failure while hospitalized
Description
Renal failure is defined as any renal replacement therapy
Time Frame
inpatient hospitalization (approximately 1 to 30 days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All subjects admitted to the medical intensive care unit Exclusion Criteria: Clinical discretion of the attending physician Severe pulmonary hypertension (right ventricular systolic pressure > 60 mmHg) Unreliable pulse oximetry Unreliable non-invasive blood pressure monitoring Absolute need of arterial blood gas measurement after 5 consecutive failed arterial blood gas sticks Extracorporeal membrane oxygenation
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Terrence Wong, MD
Phone
603-650-5533
Email
Terrence.wong@hitchcock.org
First Name & Middle Initial & Last Name or Official Title & Degree
David Feller-Kopman, MD
Phone
603-650-9481
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Feller-Kopman, MD
Organizational Affiliation
Dartmouth-Hitchcock Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David J Feller-Kopman
Phone
603-650-5533
Email
dfk@dartmouth.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Pragmatic Randomized Trial for Arterial Catheters in the Critical Care Environment

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