Hypotension Clinical Trial
— GRACEOfficial title:
Pragmatic Randomized Trial for Arterial Catheters in the Critical Care Environment
Verified date | February 2024 |
Source | Dartmouth-Hitchcock Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 700 |
Est. completion date | July 14, 2023 |
Est. primary completion date | July 14, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - All subjects admitted to the medical intensive care unit Exclusion Criterion: - All subjects <18 years of age. |
Country | Name | City | State |
---|---|---|---|
United States | Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire |
Lead Sponsor | Collaborator |
---|---|
Dartmouth-Hitchcock Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | inpatient hospitalization (approximately 1 to 30 days) | |
Secondary | Number of days using a mechanical ventilator (Ventilator-days) | Number of days spent on a mechanical ventilator | inpatient hospitalization (approximately 1 to 30 days) | |
Secondary | Number of days using vasopressor medicines (vasopressor-days) | Number of days using vasopressor medicines | inpatient hospitalization (approximately 1 to 30 days) | |
Secondary | Number of blood transfusions received during hospitalization (packed red blood cell transfusions) | Number of blood transfusions received during hospitalization | inpatient hospitalization (approximately 1 to 30 days) and receiving approximately 0 - 10 blood transfusions | |
Secondary | 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 | inpatient hospitalization (approximately 1 to 30 days) and experiencing 0 to 1 bloodstream infections | |
Secondary | Number of participants experiencing a vascular injury related to the invasive arterial catheter | vascular injuries include hematoma formation, ischemic limb, false aneurysm, limb injury | inpatient hospitalization (approximately 1 to 30 days) | |
Secondary | 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 | Inpatient or outpatient death within 1 to 28 days | |
Secondary | 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 | Inpatient or outpatient death within 1 to 28 days | |
Secondary | 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 | Inpatient or outpatient death within 1 to 90 days | |
Secondary | Number of patients experiencing renal failure while hospitalized | Renal failure is defined as any renal replacement therapy | inpatient hospitalization (approximately 1 to 30 days) | |
Secondary | Number of vasopressors used | The quantity of vasopressors | Inpatient hospitalization (approximately 1 to 60 days) | |
Secondary | Number of ABG measurements | The total quantity of ABG labs sent | Inpatient hospitalization (approximately 1 to 60 days) |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04062994 -
A Clinical Decision Support Trial to Reduce Intraoperative Hypotension
|
||
Active, not recruiting |
NCT02016599 -
Effects of Transitional Circulation in ELBW Infants
|
||
Recruiting |
NCT05836610 -
Hydrocortisone Therapy Optimization During Hypothermia Treatment in Asphyxiated Neonates
|
Phase 4 | |
Suspended |
NCT02315937 -
Hemodynamic Assessment During Spinal Anesthesia Using Transthoracic Echocardiography'
|
N/A | |
Completed |
NCT02907931 -
Carotid Doppler Ultrasound for the Measurement of Intravascular Volume Status
|
N/A | |
Completed |
NCT03215797 -
Phenylephrine or Norepinephrine for a Better Hemodynamic Stability
|
Phase 3 | |
Recruiting |
NCT02532270 -
Detecting Hypotension By Continuous Non-invasive Arterial Pressure Monitoring
|
N/A | |
Completed |
NCT02802683 -
Hemodynamic Impact of Hyperbaric Versus Isobaric for Spinal Anesthesia During Cesarean Delivery
|
Phase 4 | |
Completed |
NCT02437799 -
Dicrotic Notch and Hypotension at Caesarean Under Spinal Anaesthesia
|
N/A | |
Not yet recruiting |
NCT01941472 -
Transcutaneous pO2, Transcutaneous pCO2 and Central Venous pO2 Variations to Predict Fluid Responsiveness
|
N/A | |
Completed |
NCT02146898 -
The Severity Of Hypotension Comparing Three Positions During Spinal Anesthesia For Cesarean Delivery
|
N/A | |
Completed |
NCT01930227 -
Transcutaneous Electrical Acupoint Stimulation(TEAS) for Hypotension After Spinal Anesthesia in Parturients
|
N/A | |
Recruiting |
NCT01434251 -
Treatment of Hypotension of Prematurity (TOHOP)
|
N/A | |
Withdrawn |
NCT01183741 -
Accuracy of Non-Invasive Blood Pressure Measurement in Adults
|
Phase 3 | |
Completed |
NCT01592669 -
Passive Leg Raising Attenuates and Delays Tourniquet Deflation-induced Hypotension and Tachycardia
|
N/A | |
Completed |
NCT00991627 -
Different Approaches to Maternal Hypotension During Cesarean Section
|
Phase 4 | |
Withdrawn |
NCT00750516 -
Lactic Acid Levels In Hypotensive Patients Without(Standard) and With Tourniquet
|
||
Completed |
NCT00115726 -
Trial Assessing the Effect of Preoperative Furosemide on Intraoperative Blood Pressure
|
Phase 4 | |
Recruiting |
NCT05513066 -
Management Arterial Hypotension During Planned Caesarean Section, Intravenous Ephedrine/Phenylephrine Mixture Versus Intravenous Baby Noradrenaline
|
||
Completed |
NCT04089644 -
Manual vs Closed-loop Control of Mean Arterial Pressure
|
N/A |