N/A
N=150
Fluid Responsiveness Evaluation in Sepsis-associated Hypotension
Sepsis · Hypotension
Bottom Line
View on ClinicalTrials.gov: NCT02837731 ↗Enrolled (actual)
150
Serious AEs
11.3%
Results posted
Dec 2020
Primary outcome: Primary: Fluid Balance — 0.65; 2.02 Liters — p=0.021
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Treatment Starling SV monitor (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Cheetah Medical Inc.
- Primary completion
- Mar 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Fluid Balance |
0.65; 2.02 | 0.021 sig |
| SECONDARY Percentage of Participants Requiring Renal Replacement Therapy |
5.1; 17.5 | 0.042 sig |
| SECONDARY Percentage of Participants Requiring Ventilator Use |
17.7; 34.1 | 0.044 sig |
| SECONDARY Length of ICU Stay |
3.31; 6.22 | 0.113 |
| SECONDARY Number of Hours of Ventilator Use |
46.99; 119.42 | — |
| SECONDARY Number of Hours of Vasopressor Use |
40.74; 55.64 | 0.426 |
| SECONDARY Change From Baseline in Serum Creatinine Levels at 72 Hours |
0.13; 0.04 | 0.453 |
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.
Eligibility Criteria
Inclusion Criteria
- 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 90/min
- Respiratory rate of > 20/min or PaCO2 12000/mm3 or 10% immature bands
- 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
Exclusion Criteria
- 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
- 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
Data sourced from ClinicalTrials.gov (NCT02837731). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.