Fluid Responsiveness Evaluation in Sepsis-associated Hypotension

Completed · Not applicable

Conditions studied: Sepsis, Hypotension

In brief

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.

Key facts

Study ID

NCT02837731

Run by

Cheetah Medical Inc.

People needed

150

Starts

2016-10-01

Expected to finish

2019-03-13

Last updated by the study team

2020-12-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 < 36 C
• Heart rate of > 90/min
• Respiratory rate of > 20/min or PaCO2 < 32 mm Hg (4.3 kPA)
• White blood cell count > 12000/mm3 or < 4000/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

You may not qualify if…

• 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

Where it is running

• University of California San Francisco Medical Center — San Francisco, California, United States
• Denver Health — Denver, Colorado, United States
• Grady Memorial Hospital — Atlanta, Georgia, United States
• Indiana University Methodist Hospital — Indianapolis, Indiana, United States
• NYU School of Medicine — New York, New York, United States
• New York Presbyterian Brooklyn Methodist Hospital — New York, New York, United States
• Ohio State University Hospital — Columbus, Ohio, United States
• Oregon Health and Science University — Portland, Oregon, United States
• Rhode Island Hospital — Providence, Rhode Island, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• Baylor College of Medicine — Houston, Texas, United States
• Royal Surrey County Hospital — Guildford, United Kingdom

Full record on ClinicalTrials.gov

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