Mechanical Ventilation ComplicationGRACENCT05411315
Pragmatic Randomized Trial for Arterial Catheters in the Critical Care Environment
A study testing Restricted-use of arterial catheter and Standard-use of arterial catheter in people with Mechanical Ventilation Complication and Arterial Thrombosis, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mechanical Ventilation Complication, Arterial Thrombosis, Limb Ischemia
- What is being tested?
- Restricted-use of arterial catheter and Standard-use of arterial catheter
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 700 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Oct 2022to 14 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All subjects admitted to the medical intensive care unit
Who cannot join
- All subjects <18 years of age.
Trial locations and contacts
1 site in 1 country.
United States1 site
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
About this study
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.
Read the 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.
- Conditions
- Mechanical Ventilation Complication, Arterial Thrombosis, Limb Ischemia, Shock, Hypotension, Bloodstream Infection
- Being tested
- Restricted-use of arterial catheter, Standard-use of arterial catheter
- Medical subject headings
- Shock, Hypotension, Sepsis, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Restricted-use of arterial catheterOther
The investigator will restrict the use of arterial catheters unless exclusion criteria is met.
Standard-use of arterial catheterOther
The investigator will allow standard-use of arterial catheters
| Study group | Role | What they receive |
|---|---|---|
| Restricted-use of arterial catheters | Experimental | Not described Receives: Other: Restricted-use of arterial catheter |
| Standard-use of arterial catheters | Active comparator | Not described Receives: Other: Standard-use of arterial catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of days hospitalized in the medical intensive care unit (length-of-stay)
Number of days hospitalized in the medical intensive care unit
Measured: 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)
Number of days hospitalized in a non- medical intensive care unit
Measured: inpatient hospitalization (approximately 1 to 30 days)
Number of days using a mechanical ventilator (Ventilator-days)
Number of days spent on a mechanical ventilator
Measured: inpatient hospitalization (approximately 1 to 30 days)
Number of days using vasopressor medicines (vasopressor-days)
Number of days using vasopressor medicines
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: inpatient hospitalization (approximately 1 to 30 days)
Number of vasopressors used
The quantity of vasopressors
Measured: Inpatient hospitalization (approximately 1 to 60 days)
Number of ABG measurements
The total quantity of ABG labs sent
Measured: Inpatient hospitalization (approximately 1 to 60 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2022
- Study start17 Oct 2022
- Primary completion14 Jul 2023
- Study completion14 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanical Ventilation ComplicationStudies of the same condition, open and under way.
- More trials run by Dartmouth-Hitchcock Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pragmatic randomized trial
- Masking
- None (open label)
- Enrolment
- 700 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David J. Feller-Kopman, Dartmouth-Hitchcock Medical Center
- Investigators
- David Feller-Kopman, MD, Principal investigator, Dartmouth-Hitchcock Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05411315
- Sponsor's protocol ID
- STUDY02001496
- Acronym
- GRACE
- Status last verified
- Feb 2024
- First submitted
- 6 Jun 2022
- Last updated
- 26 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pragmatic Randomized Trial for Arterial Catheters in the Critical Care Environment
- ClinicalTrials.gov ID
- NCT05411315
- Acronym / sponsor ID
- GRACE / STUDY02001496
- Conditions
- Mechanical Ventilation Complication, Arterial Thrombosis, Limb Ischemia, Shock, Hypotension, Bloodstream Infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 700 participants (actual)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Study start
- 17 Oct 2022 (actual)
- Primary completion
- 14 Jul 2023 (actual)
- Study completion
- 14 Jul 2023 (actual)
- First posted
- 9 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Pragmatic randomized trial
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All subjects admitted to the medical intensive care unit
Key exclusion criteria (1 listed)
- All subjects <18 years of age.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Restricted-use of arterial catheterThe investigator will restrict the use of arterial catheters unless exclusion criteria is met. | Other | Restricted-use of arterial catheters |
| Standard-use of arterial catheterThe investigator will allow standard-use of arterial catheters | Other | Standard-use of arterial catheters |
Primary outcome
Number of days hospitalized in the medical intensive care unit (length-of-stay)
Time frame: inpatient hospitalization (approximately 1 to 30 days)
Number of days hospitalized in the medical intensive care unit
12 secondary outcomes
Number of days hospitalized in a non- medical intensive care unit (Hospital length-of-stay)
Time frame: inpatient hospitalization (approximately 1 to 30 days)
Number of days using a mechanical ventilator (Ventilator-days)
Time frame: inpatient hospitalization (approximately 1 to 30 days)
Number of days using vasopressor medicines (vasopressor-days)
Time frame: inpatient hospitalization (approximately 1 to 30 days)
Number of blood transfusions received during hospitalization (packed red blood cell transfusions)
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: Inpatient or outpatient death within 1 to 90 days
Number of patients experiencing renal failure while hospitalized
Time frame: inpatient hospitalization (approximately 1 to 30 days)
Number of vasopressors used
Time frame: Inpatient hospitalization (approximately 1 to 60 days)
Number of ABG measurements
Time frame: Inpatient hospitalization (approximately 1 to 60 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Feller-Kopman, MD principal investigator
Dartmouth-Hitchcock Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Restricted-use of arterial catheter and Standard-use of arterial catheter in people with Mechanical Ventilation Complication and Arterial Thrombosis, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of days hospitalized in the medical intensive care unit (length-of-stay) (time frame: inpatient hospitalization (approximately 1 to 30 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2024.