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Fluid Responsiveness Evaluation in Sepsis-associated Hypotension (FRESH)

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ClinicalTrials.gov Identifier: NCT02837731
Recruitment Status : Recruiting
First Posted : July 20, 2016
Last Update Posted : May 18, 2018
Sponsor:
Information provided by (Responsible Party):
Cheetah Medical Inc.

Brief Summary:
This study assesses the mean difference in fluid balance at ICU discharge and associated patient outcomes, based on a dynamic assessment of fluid responsiveness in septic patients with refractory hypotension in an ICU setting.

Condition or disease Intervention/treatment Phase
Sepsis Hypotension Device: Treatment Starling SV monitor Not Applicable

Detailed Description:

Multi-center randomized study comparing dynamic assessment of fluid responsiveness utilizing Starling SV monitor compared to a control group.

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 210 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Fluid Volume in Patients With Sepsis and Refractory Hypotension
Actual Study Start Date : October 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : February 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Device: 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.

No Intervention: Control
No required therapeutic protocol will be used for patient treatment, and is determined per the discretion of the physician and hospital standards.



Primary Outcome Measures :
  1. Fluid balance [ Time Frame: 72 hours ]
    Mean difference in fluid balance (L) at 72 hours or ICU discharge, whichever occurs first, between the two treatment groups


Secondary Outcome Measures :
  1. Length of ICU stay [ Time Frame: 30 days ]
    Length of ICU stay (days) until subject is medically ready for discharge

  2. Number of hours free from ventilator [ Time Frame: 30 days ]
    Number of hours free from ventilator use (30 day period)

  3. Number of hours free from vasopressor use [ Time Frame: 30 days ]
    Number of hours free from vasopressor use



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Diagnosis of sepsis, as exhibited by 2 or more of the following systemic inflammatory response syndrome (SIRS) criteria and a known or presumed infection at time of screening:

    • 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:

  1. Primary diagnosis of: acute cerebral vascular event, acute coronary syndrome, acute pulmonary edema, status asthmaticus, major cardiac arrhythmia, drug overdose, or injury from burn or trauma
  2. Known aortic insufficiency, or aortic abnormalities
  3. Hemodynamic instability due to active gastrointestinal hemorrhage
  4. Requires immediate surgery
  5. Patient transferred to the ICU from another hospital unit
  6. Do not attempt resuscitation (DNAR or DNR) order
  7. Advanced directives restricting implementation of the resuscitation protocol
  8. Contraindication to blood transfusion
  9. Attending clinician deems aggressive resuscitation unsuitable
  10. Transferred from another in-hospital setting
  11. Not able to commence treatment protocol within 1 hour after randomization
  12. Known intraventricular heart defect, such as ventral septal defect or atrial septal defect
  13. Use of additional hemodynamic monitoring involving stroke volume variation (SVV) to determine fluid responsiveness
  14. Seizure in the last 24 hours
  15. Prisoner
  16. Pregnancy
  17. Age <18
  18. Known allergy to sensor material or gel
  19. Inability or contraindication to doing a passive leg raise with both extremities, such as inability to interrupt venous compression boots
  20. Suspected intra-abdominal hypertension
  21. Inability to obtain IV access
  22. Patient should be excluded based on the opinion of the Clinician/Investigator

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02837731


Contacts
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Contact: Jennifer Sahatjian, Psy.D 781-223-1038 jennifer.sahatjian@cheetah-medical.com

Locations
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United States, Colorado
Denver Health Recruiting
Denver, Colorado, United States, 80204
Contact: Terra Hiller, RN       terra.hiller@dhha.org   
Principal Investigator: Ivor Douglas, MD         
United States, Texas
Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030
Contact: Caryn Pope, RRT    713-873-2471    cpope@bcm.edu   
Principal Investigator: Philip Alapat, MD         
Sponsors and Collaborators
Cheetah Medical Inc.

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Responsible Party: Cheetah Medical Inc.
ClinicalTrials.gov Identifier: NCT02837731     History of Changes
Other Study ID Numbers: PRO-OOO1
First Posted: July 20, 2016    Key Record Dates
Last Update Posted: May 18, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Summary data will be reviewed periodically

Additional relevant MeSH terms:
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Sepsis
Toxemia
Hypotension
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases