Clinical trial NCT05101031: Evaluation of Fluid Volume in Patients With Refractory Hypotension (Fresh-ER)
Official title: Evaluation of Fluid Volume in Patients With Refractory Hypotension (Fresh-ER)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Undifferentated Shock
Keywords: Resuscitation
Lead sponsor: Denver Health and Hospital Authority
Sponsor class: OTHER
Collaborators: name: Oregon Health and Science University
name: Baxter Healthcare Corporation
First posted: 2021-10-29
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

Primary Criteria

1. MAP \<65
2. SBP \<90 or BP rapidly trending lower

   Secondary Criteria
3. Low urine output Acute change in urine output less than 50ml/4 hours
4. Persistent hyperlactatemia
5. A new vasopressor started
6. Acute change in HR less than 50 or greater than 120
7. New onset chest pain or chest pain different then admission assessment
8. Acute bleeding
9. Fever \> 39 degrees
10. Significant change in mental status: confusion, agitation, delirium, etc.
11. Unexplained lethargy
12. CRT \>2 seconds -

Exclusion Criteria:

1. 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
2. Known aortic insufficiency, or aortic abnormalities
3. Requires immediate surgery
4. Advanced directives restricting implementation of the resuscitation protocol
5. Known intraventricular heart defect, such as VSD or ASD
6. Prisoner
7. Pregnancy
8. Age \<18
9. Known allergy to sensor material or gel
10. Suspected intra-abdominal hypertension
11. Inability to obtain IV access
12. Patient should be excluded based on the opinion of the Clinician/Investigator
13. Patient has an unstable airway

Primary outcomes:
measure: Stroke Volume Change
timeFrame: During fluid bolus
Secondary outcomes:
measure: Stroke Volume Difference
timeFrame: during fluid bolus
measure: Fluid Input and Output
timeFrame: 72 hours
measure: LOS in ICU
timeFrame: Up to 180 days from ICU admission
measure: Mechanical ventilation
timeFrame: 28 days
measure: Vasopressor Use
timeFrame: 28 days
measure: Serum Creatinine Levels
timeFrame: 28 days
measure: Renal Replacement Therapy
timeFrame: 28 days
measure: MACE
timeFrame: 28 days
measure: Adverse Events
timeFrame: 28 days
measure: Mortality
timeFrame: 28 days
measure: Discharge Location
timeFrame: Up to 180 days from hospital admission
measure: Fluid Input and Output in ICU
timeFrame: 28 days
Other outcomes:
Locations:
city: Denver
country: United States
facility: Denver Health Medical Center
state: Colorado
Study officials:
affiliation: Denver Health Medical Center
name: Ivor Douglas, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Marik 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.
citation: Michard 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.
citation: Kelm 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.
citation: Boyd 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.
citation: Vincent et al. Sepsis in European ICU: Results of the SOAP study. British Journal of Anesthesia 2006; 113: 740-747.