De-resuscitation Informed by Ultrasound for Patients With Sepsis
Status unconfirmed · Not applicable
Conditions studied: Sepsis, Septic Shock, Sepsis, Severe, Volume Overload
In brief
Randomized, unblinded clinical trial of 152 critically ill patients with sepsis admitted to the intensive care unit. The primary determine if using the Venous Excess Ultrasound Score (VExUS) to guide fluid deresuscitation in critically ill patients with sepsis reduces net fluid balance at 5 days as compared to usual care.
Key facts
- Study ID
- NCT04921319
- Run by
- The Miriam Hospital
- People needed
- 152
- Starts
- 2021-04-26
- Expected to finish
- 2022-07-30
- Last updated by the study team
- 2021-06-10
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 1. Must be suspected by the treating physician to have sepsis as the primary cause of their acute illness as exhibited by 2 or more of the following Systemic Inflammatory Response Syndrome (SIRS) criteria:
- Temperature of > 38 C or < 36 C
- Heart rate of > 90/min
- Respiratory rate of > 20/min or PaCO2 < 32 mm Hg
- White blood cell count > 12000/mm3 or < 4000/mm3 or >10% immature bands. 2. Known or suspected infection at the time of screening 3. Admission to the ICU for <24 hours
- Since approximately 12% of patients ultimately diagnosed with sepsis do not meet SIRS criteria, SIRS negative patients will be eligible for the study if the treating physician makes a clinical diagnosis of severe sepsis or septic shock.
You may not qualify if…
- Patients with conditions that may interfere with portal Doppler assessments such as cirrhosis or portal thrombosis
- Patients with severe chronic kidney disease (estimated glomerular filtration rate<15 mL/min per 1.73 m2 calculated using the Modified Diet in Renal Disease formula).
- Age < 18 years
- Active atrial fibrillation or atrial flutter
- Hemodynamic instability due to active hemorrhage
- Acute cerebral vascular event
- Acute coronary syndrome (excluding elevated troponin thought to be from demand ischemia)
- Acute pulmonary edema
- Status asthmaticus
- Drug overdose
- Injury from burn or trauma
- Status epilepticus
- Indication for immediate surgery
- Received CPR within 24 hours of enrollment
- Pregnancy
- Incarceration.
Where it is running
- The Miriam Hospital — Providence, Rhode Island, United States (enrolling)
Full record on ClinicalTrials.gov
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