Undifferentated ShockFresh-ERNCT05101031
Evaluation of Fluid Volume in Patients With Refractory Hypotension (Fresh-ER)
An observational study of Undifferentated Shock, run by Ivor Douglas at 1 site in United States.
Trial summary
The objective of the study is to observe the change in hemodynamic variables (i.e. CO, SV, HR, SV) as assessed during rapid fluid bolus. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Undifferentated Shock
- What is being tested?
- Starling SV
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Dec 2020to 17 Dec 2022
- Phase
- Observational
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will be drawn from all patients who undergo present to the Emergency Room with symptoms of suspected or confirmed septic shock, and who are identified to receive a 30cc/kg fluid bolus of resuscitation fluid as part of treatment.
Who may be able to join
- Primary Criteria
- MAP <65
- SBP <90 or BP rapidly trending lower
- Secondary Criteria
- Low urine output Acute change in urine output less than 50ml/4 hours
- Persistent hyperlactatemia
Show all 14Show fewer
- A new vasopressor started
- Acute change in HR less than 50 or greater than 120
- New onset chest pain or chest pain different then admission assessment
- Acute bleeding
- Fever > 39 degrees
- Significant change in mental status: confusion, agitation, delirium, etc.
- Unexplained lethargy
- CRT >2 seconds -
Who cannot join
- Primary diagnosis of: acute cerebral vascular event, acute coronary syndrome, acute pulmonary edema, status asthmatics, major cardiac arrhythmia, drug overdose, or injury from burn or trauma
- Known aortic insufficiency, or aortic abnormalities
- Requires immediate surgery
- Advanced directives restricting implementation of the resuscitation protocol
- Known intraventricular heart defect, such as VSD or ASD
- Prisoner
Show all 13Show fewer
- Pregnancy
- Age <18
- Known allergy to sensor material or gel
- Suspected intra-abdominal hypertension
- Inability to obtain IV access
- Patient should be excluded based on the opinion of the Clinician/Investigator
- Patient has an unstable airway
Trial locations and contacts
1 site in 1 country.
United States1 site
Denver Health Medical Center
Denver, Colorado, 80204
About this study
The objective of the study is to observe the change in hemodynamic variables (i.e. CO, SV, HR, SV) as assessed during rapid fluid bolus.
Read the detailed description
The Noninvasive Starling SV (Baxter Healthcare) is a portable, non-invasive, cardiac output detector system. The Starling SV system measures the cardiac output by employing electrical bioreactance. Bioreactance is a measure of the electrical characteristics of a volume of tissue and fluid. In the case of cardiac output measurements, the relevant tissue includes the heart and the immediate surrounding volume of the thorax. The relevant fluid is blood.
The objective of the study is observe the change in hemodynamic variables (i.e. CO, SV, HR, SV) as assessed during the initial resuscitation of 30 ml/kg of fluid, to evaluate the feasibility of performing a larger prospective RCT of SV-guided resuscitation in patients who undergo a dynamic assessment of fluid responsiveness to help guide fluid administration.
This study is a prospective feasibility study. Patients will be evaluated by the Emergency Room team for Inclusion/Exclusion criteria. If the patient is found to fit the study inclusion and exclusion criteria, then the fully non-invasive Starling monitor will be applied to the patient and the patient's hemodynamic data will be prospectively collected during the initial fluid resuscitation.
- Conditions
- Undifferentated Shock
- Being tested
- Starling SV
- Keywords
- Resuscitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Starling SVDevice
The Starling SV will monitor the change in hemodynamic variables (i.e. CO, SV, HR, SV) as assessed during the initial fluid resuscitation in individuals with hypotension related to infection.
| Study group | Role | What they receive |
|---|---|---|
| Denver Health Medical Center | SV machine will be attached if hypotensive and in the emergency department Receives: Device: Starling SV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stroke Volume Change
Change in stroke volume following the administration of each 500 cc fluid bolus.
Measured: During fluid bolus
Secondary outcomes (12)
Stroke Volume Difference
Concordance between change in stroke volume compared between fluid bolus and other usual care assessments of effective circulating volume
Measured: during fluid bolus
Fluid Input and Output
Fluid balance inclusive of all parenteral fluids and all output
Measured: 72 hours
LOS in ICU
Length of ICU stay (days) until subject is medically ready for discharge
Measured: Up to 180 days from ICU admission
Mechanical ventilation
Requirement for mechanical ventilation during hospitalization
Measured: 28 days
Vasopressor Use
Requirement for vasopressor use during hospitalization
Measured: 28 days
Serum Creatinine Levels
Changes in serum creatinine levels from baseline
Measured: 28 days
Renal Replacement Therapy
Requirement for renal replacement therapy (RRT)
Measured: 28 days
MACE
Incidence of Major Adverse Cardiac Event (MACE)
Measured: 28 days
Adverse Events
Incident of Adverse Events
Measured: 28 days
Mortality
Inhospital Mortality rate
Measured: 28 days
Discharge Location
Discharge location after hospitalization
Measured: Up to 180 days from hospital admission
Fluid Input and Output in ICU
Mean difference in fluid balance at ICU discharge
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2021
- Study start18 Dec 2020
- Primary completion17 Dec 2022
- Study completion17 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Undifferentated ShockStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ivor Douglas
- Sponsor type
- University, hospital or other
- Collaborators
- Oregon Health and Science University, Baxter Healthcare Corporation
- Responsible party
- Sponsor-investigator, Ivor Douglas, Denver Health and Hospital Authority
- Investigators
- Ivor Douglas, MD, Principal investigator, Denver Health Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05101031
- Sponsor's protocol ID
- 20-2845
- Acronym
- Fresh-ER
- Status last verified
- Nov 2023
- First submitted
- 22 Jun 2021
- Last updated
- 21 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Monnet X, Teboul JL. Passive leg raising. Intensive Care Med. 2008 Apr;34(4):659-63. doi: 10.1007/s00134-008-0994-y. Epub 2008 Jan 23.
PubMed 18214429Marik PE, Cavallazzi R. Does the central venous pressure predict fluid responsiveness? An updated meta-analysis and a plea for some common sense. Crit Care Med. 2013 Jul;41(7):1774-81. doi: 10.1097/CCM.0b013e31828a25fd.
PubMed 23774337Michard F, Teboul JL. Predicting fluid responsiveness in ICU patients: a critical analysis of the evidence. Chest. 2002 Jun;121(6):2000-8. doi: 10.1378/chest.121.6.2000.
PubMed 12065368Kelm DJ, Perrin JT, Cartin-Ceba R, Gajic O, Schenck L, Kennedy CC. Fluid overload in patients with severe sepsis and septic shock treated with early goal-directed therapy is associated with increased acute need for fluid-related medical interventions and hospital death. Shock. 2015 Jan;43(1):68-73. doi: 10.1097/SHK.0000000000000268.
PubMed 25247784Boyd JH, Forbes J, Nakada TA, Walley KR, Russell JA. Fluid resuscitation in septic shock: a positive fluid balance and elevated central venous pressure are associated with increased mortality. Crit Care Med. 2011 Feb;39(2):259-65. doi: 10.1097/CCM.0b013e3181feeb15.
PubMed 20975548Vincent et al. Sepsis in European ICU: Results of the SOAP study. British Journal of Anesthesia 2006; 113: 740-747.
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Fluid Volume in Patients With Refractory Hypotension (Fresh-ER)
- ClinicalTrials.gov ID
- NCT05101031
- Acronym / sponsor ID
- Fresh-ER / 20-2845
- Conditions
- Undifferentated Shock
- Keywords
- Resuscitation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Ivor DouglasUniversity, hospital or other
- Collaborators
- Oregon Health and Science University, Baxter Healthcare Corporation
- Study start
- 18 Dec 2020 (actual)
- Primary completion
- 17 Dec 2022 (actual)
- Study completion
- 17 Dec 2022 (actual)
- First posted
- 29 Oct 2021 (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.
The objective of the study is to observe the change in hemodynamic variables (i.e. CO, SV, HR, SV) as assessed during rapid fluid bolus.
Detailed description
The Noninvasive Starling SV (Baxter Healthcare) is a portable, non-invasive, cardiac output detector system. The Starling SV system measures the cardiac output by employing electrical bioreactance. Bioreactance is a measure of the electrical characteristics of a volume of tissue and fluid. In the case of cardiac output measurements, the relevant tissue includes the heart and the immediate surrounding volume of the thorax. The relevant fluid is blood.
The objective of the study is observe the change in hemodynamic variables (i.e. CO, SV, HR, SV) as assessed during the initial resuscitation of 30 ml/kg of fluid, to evaluate the feasibility of performing a larger prospective RCT of SV-guided resuscitation in patients who undergo a dynamic assessment of fluid responsiveness to help guide fluid administration.
This study is a prospective feasibility study. Patients will be evaluated by the Emergency Room team for Inclusion/Exclusion criteria. If the patient is found to fit the study inclusion and exclusion criteria, then the fully non-invasive Starling monitor will be applied to the patient and the patient's hemodynamic data will be prospectively collected during the initial fluid resuscitation.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Denver Health Medical Center | – | Device: Starling SVSV machine will be attached if hypotensive and in the emergency department |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will be drawn from all patients who undergo present to the Emergency Room with symptoms of suspected or confirmed septic shock, and who are identified to receive a 30cc/kg fluid bolus of resuscitation fluid as part of treatment.
Key inclusion criteria (14 listed)
- Primary Criteria
- MAP <65
- SBP <90 or BP rapidly trending lower
- Secondary Criteria
- Low urine output Acute change in urine output less than 50ml/4 hours
Key exclusion criteria (13 listed)
- Primary diagnosis of: acute cerebral vascular event, acute coronary syndrome, acute pulmonary edema, status asthmatics, major cardiac arrhythmia, drug overdose, or injury from burn or trauma
- Known aortic insufficiency, or aortic abnormalities
- Requires immediate surgery
- Advanced directives restricting implementation of the resuscitation protocol
- Known intraventricular heart defect, such as VSD or ASD
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 |
|---|---|---|
| Starling SVThe Starling SV will monitor the change in hemodynamic variables (i.e. CO, SV, HR, SV) as assessed during the initial fluid resuscitation in individuals with hypotension related to infection. | Device | Denver Health Medical Center |
Primary outcome
Stroke Volume Change
Time frame: During fluid bolus
Change in stroke volume following the administration of each 500 cc fluid bolus.
12 secondary outcomes
Stroke Volume Difference
Time frame: during fluid bolus
Fluid Input and Output
Time frame: 72 hours
LOS in ICU
Time frame: Up to 180 days from ICU admission
Mechanical ventilation
Time frame: 28 days
Vasopressor Use
Time frame: 28 days
Serum Creatinine Levels
Time frame: 28 days
Renal Replacement Therapy
Time frame: 28 days
MACE
Time frame: 28 days
Adverse Events
Time frame: 28 days
Mortality
Time frame: 28 days
Discharge Location
Time frame: Up to 180 days from hospital admission
Fluid Input and Output in ICU
Time frame: 28 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 21 Nov 2023.
- Background: PubMed 18214429Monnet X, Teboul JL. Passive leg raising. Intensive Care Med. 2008 Apr;34(4):659-63. doi: 10.1007/s00134-008-0994-y. Epub 2008 Jan 23.
- Results publication: PubMed 23774337Marik PE, Cavallazzi R. Does the central venous pressure predict fluid responsiveness? An updated meta-analysis and a plea for some common sense. Crit Care Med. 2013 Jul;41(7):1774-81. doi: 10.1097/CCM.0b013e31828a25fd.
- Results publication: PubMed 12065368Michard F, Teboul JL. Predicting fluid responsiveness in ICU patients: a critical analysis of the evidence. Chest. 2002 Jun;121(6):2000-8. doi: 10.1378/chest.121.6.2000.
- Results publication: PubMed 25247784Kelm DJ, Perrin JT, Cartin-Ceba R, Gajic O, Schenck L, Kennedy CC. Fluid overload in patients with severe sepsis and septic shock treated with early goal-directed therapy is associated with increased acute need for fluid-related medical interventions and hospital death. Shock. 2015 Jan;43(1):68-73. doi: 10.1097/SHK.0000000000000268.
- Results publication: PubMed 20975548Boyd JH, Forbes J, Nakada TA, Walley KR, Russell JA. Fluid resuscitation in septic shock: a positive fluid balance and elevated central venous pressure are associated with increased mortality. Crit Care Med. 2011 Feb;39(2):259-65. doi: 10.1097/CCM.0b013e3181feeb15.
- Results publicationVincent et al. Sepsis in European ICU: Results of the SOAP study. British Journal of Anesthesia 2006; 113: 740-747.
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.
Ivor Douglas, MD principal investigator
Denver Health Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Undifferentated Shock, run by Ivor Douglas 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 14 inclusion and 13 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 21 Nov 2023. 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?
Stroke Volume Change (time frame: During fluid bolus). 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 NCT05101031, which also lists 6 linked publications.
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 21 Nov 2023.