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Procedure
Arterial Catheter Use in Critical Care Management (GRACE Trial)
N/A
Waitlist Available
Led By David Feller-Kopman, MD
Research Sponsored by Dartmouth-Hitchcock Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up inpatient hospitalization (approximately 1 to 30 days) and experiencing 0 to 1 bloodstream infections
Awards & highlights
GRACE Trial Summary
This trialwill compare using fewer invasive arterial lines to regular use to see if it's as effective.
Who is the study for?
This trial is for patients in the medical intensive care unit who can be monitored without an arterial catheter. Excluded are those with severe pulmonary hypertension, unreliable pulse oximetry or blood pressure monitoring, a need for frequent arterial blood gas tests after repeated failures, or on extracorporeal membrane oxygenation.Check my eligibility
What is being tested?
The study compares two approaches to using invasive arterial lines: 'restricted-use' where they're used less often and 'standard-use' where they're part of regular care. The goal is to see if restricted use is just as good (non-inferior) as standard use.See study design
What are the potential side effects?
Potential side effects from using arterial catheters include blood clots, infections in the bloodstream, complications related to low blood pressure and vasopressors, kidney failure due to poor circulation (ischemia), and issues from mechanical ventilation.
GRACE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ inpatient hospitalization (approximately 1 to 30 days) and receiving approximately 0 - 10 blood transfusions
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~inpatient hospitalization (approximately 1 to 30 days) and receiving approximately 0 - 10 blood transfusions
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of days hospitalized in the medical intensive care unit (length-of-stay)
Secondary outcome measures
Number of ABG measurements
Number of blood transfusions received during hospitalization (packed red blood cell transfusions)
Number of days hospitalized in a non- medical intensive care unit (Hospital length-of-stay)
+9 moreGRACE Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Restricted-use of arterial cathetersExperimental Treatment1 Intervention
Group II: Standard-use of arterial cathetersActive Control1 Intervention
Find a Location
Who is running the clinical trial?
Dartmouth-Hitchcock Medical CenterLead Sponsor
524 Previous Clinical Trials
2,542,641 Total Patients Enrolled
David Feller-Kopman, MDPrincipal InvestigatorDartmouth-Hitchcock Medical Center
1 Previous Clinical Trials
125 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- The doctor's judgment decides.You have very high blood pressure in the arteries of your lungs.The device used to measure your oxygen levels is not accurate.Inaccurate blood pressure readings taken without using a cuff around the arm.You must have an arterial blood gas test if 5 attempts to collect blood from an artery are not successful.You are using a machine to help your heart and lungs work.
Research Study Groups:
This trial has the following groups:- Group 1: Restricted-use of arterial catheters
- Group 2: Standard-use of arterial catheters
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there an ongoing recruitment of participants for this clinical trial?
"This clinical trial is still recruiting as indicated by the information on clinicaltrials.gov, which was last updated on February 13th 2023. This research study initially went online for recruitment purposes in October 17th 2022."
Answered by AI
What is the enrollment rate in this medical experiment?
"Affirmative. Clinicaltrials.gov has the latest information on this active investigation which was first announced on October 17th 2022 and was most recently modified on February 13th 2023. The research team is looking to recruit 456 people from a single centre."
Answered by AI
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