SepsisFRESHNCT02837731
Fluid Responsiveness Evaluation in Sepsis-associated Hypotension
A study testing Treatment Starling SV monitor in people with Sepsis and Hypotension, run by Cheetah Medical Inc. at 12 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis, Hypotension
- What is being tested?
- Treatment Starling SV monitor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 12 sitesin 2 countries
- Study dates
- Oct 2016to 13 Mar 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- 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
- Refractory hypotension despite initial fluid resuscitation (1L of treatment fluid)
Show all 9Show fewer
- Patient enrolled in study as soon as possible (ideal window of 0-12 hours) and within 24 hours of arrival to the hospital
- Anticipated ICU admission
- Able to provide signed informed consent or consent can be obtained from the patient's authorized representative
Who cannot join
- 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
- Known aortic insufficiency, or aortic abnormalities
- Hemodynamic instability due to active gastrointestinal hemorrhage
- Patient has received >3 liters of IV fluid prior to study randomization
- Requires immediate surgery
- Patient transferred to the ICU from another hospital unit
Show all 27Show fewer
- Do not attempt resuscitation (DNAR or DNR) order
- Advanced directives restricting implementation of the resuscitation protocol
- Contraindication to blood transfusion
- Attending clinician deems aggressive resuscitation unsuitable
- Transferred from another in-hospital setting
- Not able to commence treatment protocol within 1 hour after randomization
- Known intraventricular heart defect, such as ventral septal defect or atrial septal defect
- Use of additional hemodynamic monitoring involving stroke volume variation (SVV) to determine fluid responsiveness
- Seizure in the last 24 hours
- Prisoner
- Pregnancy
- Age <18
- Known allergy to sensor material or gel
- Inability or contraindication to doing a passive leg raise with both extremities, such as inability to interrupt venous compression boots
- Patient has an epidural catheter in place
- Suspected intra-abdominal hypertension
- Inability to obtain IV access
- Diabetic ketoacidosis
- Hyper-osmolarity syndrome
- Patient uncouples from treatment algorithm
- Patient should be excluded based on the opinion of the Clinician/Investigator
Trial locations and contacts
12 sites in 2 countries.
12 sites in 2 countries
United States11 sites
Grady Memorial Hospital
Atlanta, Georgia, 30303
Ohio State University Hospital
Columbus, Ohio, 43210
Denver Health
Denver, Colorado, 80204
Baylor College of Medicine
Houston, Texas, 77030
Indiana University Methodist Hospital
Indianapolis, Indiana, 46202
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
NYU School of Medicine
New York, New York, 10016
New York Presbyterian Brooklyn Methodist Hospital
New York, New York, 11215
Oregon Health and Science University
Portland, Oregon, 97239
Rhode Island Hospital
Providence, Rhode Island, 02903
University of California San Francisco Medical Center
San Francisco, California, 94143
About this study
Official title: Evaluation of Fluid Volume in Patients With Sepsis and Refractory Hypotension
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.
Read the 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.
- Conditions
- Sepsis, Hypotension
- Being tested
- Treatment Starling SV monitor
- Medical subject headings
- Sepsis, Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment Starling SV monitorDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Starling SV monitor | Experimental | 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. Receives: Device: Treatment Starling SV monitor |
| Control | No intervention | No required therapeutic protocol will be used for patient treatment, and is determined per the discretion of the physician and hospital standards. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fluid Balance
Fluid balance is defined as all intravenous fluids administered over a 72 hour period (or ICU discharge, whichever occurred first), minus all fluid output. Urine output was measured in the ICU in 12 hour increments.
Measured: 72 hours
Secondary outcomes (6)
Percentage of Participants Requiring Renal Replacement Therapy
Renal replacement therapy (RRT) is therapy that replaces the normal blood-filtering function of the kidneys. It is used when the kidneys are not working well, which is called kidney failure and includes acute kidney injury and chronic kidney disease. Patient receives new treatment with dialysis.
Measured: Day 1 to Day 30
Percentage of Participants Requiring Ventilator Use
Patients did not enter the study on ventilation, but required ventilator use during the study are included in the analysis.
Measured: Day 1 to Day 30
Length of ICU Stay
Intensive Car Unit (ICU) length of stay will be calculated using the earliest of date that the subject is medically ready for discharge when captured, the date of discharge, or the study exit date.
Measured: Day 1 to Day 30
Number of Hours of Ventilator Use
Patients that did not enter the study on ventilation, but required ventilator use during the study are included in the analysis.Ventilator use might have improved (less use of ventilator support), had no change, or worsened (more use of ventilator support).
Measured: Day 1 to Day 30
Number of Hours of Vasopressor Use
Vasopressor drugs are provided to restore and maintain blood pressure in patients with septic shock. Patients that have vasopressors initiated throughout the trial are included in this analysis.
Measured: Day 1 to Day 30
Change From Baseline in Serum Creatinine Levels at 72 Hours
The diagnosis of Acute Kidney Injury (AKI) is traditionally based on a rise in serum creatinine
Measured: Baseline, 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2016 (estimated)
- Study startOct 2016
- Primary completionMar 2019
- Study completion13 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cheetah Medical Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02837731
- Sponsor's protocol ID
- PRO-OOO1
- Acronym
- FRESH
- Status last verified
- Nov 2020
- First submitted
- 14 Jul 2016
- Last updated
- 3 Dec 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Summary data will be reviewed periodically
Publications
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.
PubMed 32353418
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Fluid Volume in Patients With Sepsis and Refractory Hypotension
- ClinicalTrials.gov ID
- NCT02837731
- Acronym / sponsor ID
- FRESH / PRO-OOO1
- Conditions
- Sepsis, Hypotension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Cheetah Medical Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2016 (actual)
- Primary completion
- Mar 2019 (actual)
- Study completion
- 13 Mar 2019 (actual)
- First posted
- 20 Jul 2016 (estimated)
- Results
- Posted 3 Dec 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Starling SV monitor | Experimental | Device: Treatment Starling SV monitorA 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. |
| Control | No intervention | –No required therapeutic protocol will be used for patient treatment, and is determined per the discretion of the physician and hospital standards. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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:
- Refractory hypotension despite initial fluid resuscitation (1L of treatment fluid)
- Patient enrolled in study as soon as possible (ideal window of 0-12 hours) and within 24 hours of arrival to the hospital
- Anticipated ICU admission
- Able to provide signed informed consent or consent can be obtained from the patient's authorized representative
Key exclusion criteria (27 listed)
- 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
- Known aortic insufficiency, or aortic abnormalities
- Hemodynamic instability due to active gastrointestinal hemorrhage
- Patient has received >3 liters of IV fluid prior to study randomization
- Requires immediate surgery
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 |
|---|---|---|
| Treatment Starling SV monitorA 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. | Device | Treatment Starling SV monitor |
Primary outcome
Fluid Balance
Time frame: 72 hours
Fluid balance is defined as all intravenous fluids administered over a 72 hour period (or ICU discharge, whichever occurred first), minus all fluid output. Urine output was measured in the ICU in 12 hour increments.
6 secondary outcomes
Percentage of Participants Requiring Renal Replacement Therapy
Time frame: Day 1 to Day 30
Percentage of Participants Requiring Ventilator Use
Time frame: Day 1 to Day 30
Length of ICU Stay
Time frame: Day 1 to Day 30
Number of Hours of Ventilator Use
Time frame: Day 1 to Day 30
Number of Hours of Vasopressor Use
Time frame: Day 1 to Day 30
Change From Baseline in Serum Creatinine Levels at 72 Hours
Time frame: Baseline, 72 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32353418Douglas 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.
- Individual participant dataSharing planned: Yes. Summary data will be reviewed periodically
Related trials for Sepsis
Not yet recruitingObservational study
Serum GDF-15 and LGALS3BP as Prognostic Biomarkers in Sepsis
Sepsis, Septic Shock
RecruitingPhase 3
A Trial of Adjunctive Fludrocortisone (50mcg, 100mcg or Placebo) in Critically Ill Patients With Septic Shock Receiving Hydrocortisone, Evaluating Survival and Functional Recovery and the Influence of Transcriptomic Response
Septic Shock
RecruitingObservational study
Middle East Study of Infections in Patients With Hematological Malignancies
Hematological Malignancy, Hematopoetic Stem Cell Transplantation
RecruitingObservational study
Early Detection and Kinetics of Sepsis-Induced Coagulopathy in Severe Burn Patients
Peer Bullying Intervention, Vodcast
Not yet recruitingObservational study
Comparative Study of the Genomic Characteristics of Uropathogenic Escherichia Coli According to the Severity of Community-Acquired Urinary Tract Infections in Guadeloupe (COLIGENURI)
Urinary Tract Infections
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.
The record lists no contact. Use the official record to reach the sponsor.
12 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment Starling SV monitor in people with Sepsis and Hypotension, run by Cheetah Medical Inc. at 12 sites in 2 countries.
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 9 inclusion and 27 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 3 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States, United Kingdom. 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?
Yes. Results are posted in the registry (first posted 3 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Fluid Balance (time frame: 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02837731, which also lists 1 linked publication.
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 3 Dec 2020.