sepsis blood poisoning
Conditions
Interventions
In the experimental group, personalized hemodynamic resuscitation will be guided by the Starling SV monitor. Following the administration of fluid boluses, fluid responsiveness will be assessed based
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: • Adult patients (>= 18 years of age);** • Referred to internal medicine, nephrology, geriatric medicine, oncology, hematology, lung medicine, rheumatology, gastrointestinal / liver medicine, urology, or emergency medicine (non-trauma);** • Confirmed or suspected infection according to the physician*s judgement upon arrival to the ED, based the presence of an acute phase response not due to an alternative non-infectious cause (i.e., body temperature 38°C, leukocyte count > 12 x10^9/L or C-reactive protein > 50 mg/L), and/or on symptoms suggestive for an infection (e.g. productive cough, dyspnea, dysuria, pollakisuria, abdominal pain, erythema) • Need for hemodynamic resuscitation, based on any of the following (first measurement pre-hospital or at ED arrival): o Mean arterial pressure (MAP) 40 mmHg o Lactate > 4.0 mmol/L o Shock index* > 0.9 • Enrolled in study within one hour after ED arrival * Shock index is heart rate divided by systolic blood pressure
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: • 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, diabetic ketoacidosis, hyper-osmolarity syndrome, pancreatitis • Known aortic insufficiency, aortic abnormalities, or intraventricular heart defect, such as ventral septal defect or atrial septal defect • Known advanced heart failure - meaning NYHA IV functional class HF, on waiting list for heart transplant, LVAD recipient or chronic inotrope use. • Known end-stage kidney disease (dialysis-dependent CKD stage 5 or eGFR <15 mL/min/1.73 m²) • Decompensated liver cirrhosis at ED admission (e.g., ascites, hepatic encephalopathy, or variceal bleeding) • Hemodynamic instability due to active bleeding • Patient has received >1 liter of I.V. fluid prior to study randomization • Requires immediate surgery • Transfer from another hospital after initiation of therapy (a.o. referred by another hospital ICU)*or another in-hospital setting • Pregnant women** • Trauma patients* • Suspected intra-abdominal hypertension, based on the presence of portal hypertension (i.e. presence of ascites due to liver cirrhosis, esophageal varices or as measured by Doppler ultrasound before or despite TIPS or liver transplantation) • Inability to obtain IV access • Patient uncouples from treatment algorithm • Patient should be excluded based on the opinion of the Clinician/Investigator • Not able to commence treatment protocol within 1 hour after randomization • Potential ICU-admission unwanted by advanced care directive (e.g., limited life expectancy)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary end point is the volume (in Liters) of I.V. fluid resuscitation at three hours since ED admission. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end points include efficacy (a.o. hospital admission, length-of-stay, new onset organ failure), safety (a.o. adverse events, mortality), health-technology (a.o. cost-effectiveness) and exploratory mechanistic parameters. | — |
Countries
Netherlands
Contacts
Public ContactS Ter Horst
Universitair Medisch Centrum Groningen
Outcome results
None listed