Fluid Responsiveness Evaluation in Sepsis-associated Hypotension
NCT ID: NCT02837731
Last Updated: 2020-12-03
Study Results
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View full resultsBasic Information
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COMPLETED
NA
150 participants
INTERVENTIONAL
2016-10-31
2019-03-13
Brief Summary
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Detailed Description
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Subjects will be randomized in a 2:1 treatment to control group ratio to increase power for sub-analysis by patient population.
Patients randomized to the Starling SV arm will have treatment guided by a dynamic assessment of fluid responsiveness (measured by a change in stroke volume index \> 10%) as assessed by passive leg raise (PLR).
Patients randomized to the control group will receive standard of care treatment.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Treatment Starling SV monitor
A dynamic assessment of fluid responsiveness using the Starling SV monitor will be performed at every clinical decision point for the first 72 hours of study enrollment. Examples of a clinical decision point include a mean arterial pressure (MAP) of \< 65, the decision to give additional fluid volume, and the decision to either escalate or wean vasopressors. Fluid responsiveness will be assessed using a passive leg raise (PLR) to guide corresponding treatment.
Treatment Starling SV monitor
A dynamic assessment of fluid responsiveness will be performed at every clinical decision point for the first 72 hours of study enrollment. Fluid responsiveness will be assessed using a passive leg raise (PLR) and Starling SV hemodynamic monitor to guide corresponding treatment.
Control
No required therapeutic protocol will be used for patient treatment, and is determined per the discretion of the physician and hospital standards.
No interventions assigned to this group
Interventions
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Treatment Starling SV monitor
A dynamic assessment of fluid responsiveness will be performed at every clinical decision point for the first 72 hours of study enrollment. Fluid responsiveness will be assessed using a passive leg raise (PLR) and Starling SV hemodynamic monitor to guide corresponding treatment.
Eligibility Criteria
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Inclusion Criteria
* Temperature of \> 38 C or \< 36 C
* Heart rate of \> 90/min
* Respiratory rate of \> 20/min or PaCO2 \< 32 mm Hg (4.3 kPA)
* White blood cell count \> 12000/mm3 or \< 4000/mm3 or \>10% immature bands
2. Refractory hypotension despite initial fluid resuscitation (1L of treatment fluid)
3. Patient enrolled in study as soon as possible (ideal window of 0-12 hours) and within 24 hours of arrival to the hospital
4. Anticipated ICU admission
5. Able to provide signed informed consent or consent can be obtained from the patient's authorized representative
Exclusion Criteria
2. Known aortic insufficiency, or aortic abnormalities
3. Hemodynamic instability due to active gastrointestinal hemorrhage
4. Patient has received \>3 liters of IV fluid prior to study randomization
5. Requires immediate surgery
6. Patient transferred to the ICU from another hospital unit
7. Do not attempt resuscitation (DNAR or DNR) order
8. Advanced directives restricting implementation of the resuscitation protocol
9. Contraindication to blood transfusion
10. Attending clinician deems aggressive resuscitation unsuitable
11. Transferred from another in-hospital setting
12. Not able to commence treatment protocol within 1 hour after randomization
13. Known intraventricular heart defect, such as ventral septal defect or atrial septal defect
14. Use of additional hemodynamic monitoring involving stroke volume variation (SVV) to determine fluid responsiveness
15. Seizure in the last 24 hours
16. Prisoner
17. Pregnancy
18. Age \<18
19. Known allergy to sensor material or gel
20. Inability or contraindication to doing a passive leg raise with both extremities, such as inability to interrupt venous compression boots
21. Patient has an epidural catheter in place
22. Suspected intra-abdominal hypertension
23. Inability to obtain IV access
24. Diabetic ketoacidosis
25. Hyper-osmolarity syndrome
26. Patient uncouples from treatment algorithm
27. Patient should be excluded based on the opinion of the Clinician/Investigator
18 Years
ALL
No
Sponsors
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Cheetah Medical Inc.
INDUSTRY
Responsible Party
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Locations
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University of California San Francisco Medical Center
San Francisco, California, United States
Denver Health
Denver, Colorado, United States
Grady Memorial Hospital
Atlanta, Georgia, United States
Indiana University Methodist Hospital
Indianapolis, Indiana, United States
NYU School of Medicine
New York, New York, United States
New York Presbyterian Brooklyn Methodist Hospital
New York, New York, United States
Ohio State University Hospital
Columbus, Ohio, United States
Oregon Health and Science University
Portland, Oregon, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Baylor College of Medicine
Houston, Texas, United States
Royal Surrey County Hospital
Guildford, , United Kingdom
Countries
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References
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Douglas IS, Alapat PM, Corl KA, Exline MC, Forni LG, Holder AL, Kaufman DA, Khan A, Levy MM, Martin GS, Sahatjian JA, Seeley E, Self WH, Weingarten JA, Williams M, Hansell DM. Fluid Response Evaluation in Sepsis Hypotension and Shock: A Randomized Clinical Trial. Chest. 2020 Oct;158(4):1431-1445. doi: 10.1016/j.chest.2020.04.025. Epub 2020 Apr 27.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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PRO-OOO1
Identifier Type: -
Identifier Source: org_study_id