None listed
Conditions
Brief summary
This modified prospective cohort style study design will aim to analyse and validate the use of the delta-carotid velocity time integral to predict volume responsiveness in sepsis. Appropriate volume resuscitation is a hallmark of emergency medicine practice. Optimal volume resuscitation is often complex and increasingly controversial, with wide discrepancies in practice and guidelines. A large spectrum of guidelines exist on the ‘ideal’ fluid resuscitation, the majority focusing on sepsis. The current Surviving Sepsis guidelines recommend aggressive high volume fluid resuscitation in sepsis induced hypoperfusion . Other guideline range from high volume fluid resuscitation in all sepsis patients , to a fluid challenge in septic shock only . Our study will focus on the emergency department population, with an aim to validate this test allowing use in clinical practise. We will address the critique of high patient heterogeneity in previous studies by focusing on emergency department patients with a working diagnosis of sepsis. We propose that determining optimal intravascular filling and the timing of vasopressor use would be the most frequent clinical application of this test in clinical practice, especially given current controversies in the agreed optimal fluid resuscitation of these patients.
Interventions
Design: Prospective cohort study, diagnostic test study
Location: St Vincent's Hospital, Melbourne
Recruitment: opportunistic
Exposure arm: positive delta carotid velocity time integral (positive delta-cVTI)
Comparative arm: negative delta carotid velocity time interval (negative delta-cVTI)
Patients meeting the inclusion criteria will be recruited in to the study by a study investigator, and the study protocol will run in parallel to standard clinical care. Participants will have a standard se
Design: Prospective cohort study, diagnostic test study Location: St Vincent's Hospital, Melbourne Recruitment: opportunistic Exposure arm: positive delta carotid velocity time integral (positive delta-cVTI) Comparative arm: negative delta carotid velocity time interval (negative delta-cVTI) Patients meeting the inclusion criteria will be recruited in to the study by a study investigator, and the study protocol will run in parallel to standard clinical care. Participants will have a standard set of observations performed. Participants will have ultrasound measurements performed by echocardiography trained clinicians. Participants will then have a left ventricular outflow tract velocity time integral (LVOT VTI) measurement performed using the phased ultrasound probe, with a 5 chamber view, while lying on the bed with the head elevated to 45 degrees. Using the linear probe, the right carotid diameter 1-2cm below the carotid bifurcation will be measured and recorded, the probe will be rotated 90degrees from diameter measurement and use pulsed wave doppler to calculate the carotid VTI, and carotid VTI respiratory variation. The ultrasound site used will be marked with a marker. The patient will then be placed in the supine position with the legs elevated to 45 degrees. Using the same approach detailed above the LVOT VTI and cVTI will be remeasured. Participants will the be returned to the original lying, head-up position and given a 500ml bolus of crystalloid as per standard clinical care. Another set of standard observations will be taken and a repeat LVOT VTI and cVTI measured. All ultrasound images will be recorded by the scanning investigator in an anonymised fashion using their study number. Images will be reviewed and the change (delta) in carotid VTI and change in LVOT VTI and each stage will be calculated be a separate investigator, to minimise bias and ensure ultrasound image quality. We expect the protocol to take 30 minutes to complete per patient.
Sponsors
St Vincent's hospital Melbourne
Study design
Allocation
Non-randomised trial
Intervention model
Parallel
Primary purpose
Diagnosis
Masking
Blinded (masking used) (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1) Working diagnosis of sepsis* *Surviving sepsis 2016 definition: Potential source of infection with 2 of: - SBP < /= 100 - RR >/= 22 - GCS < 15 2) >/= 18y/o 3) Sinus Rhythm
Exclusion criteria
1) Treating clinician determined contra-indication to fluid challenge 2) Concurrent vasopressin use 3) Pregnancy 4) Cardiac arrest due to severe hypotension or sepsis 5) Clinical hypervolaemia - decompensated chronic liver disease with ascites - nephrotic syndrome - severe cardiomyopathy with evidence of fluid overload (elevated JVP, bilateral pedal oedema, bibasal creps)
Outcome results
None listed