Fluid Management and Individualized Resuscitation in Sepsis

Launched by UNIVERSITY MEDICAL CENTER GRONINGEN · May 29, 2025

Keywords

ClinConnect Summary

This clinical trial is studying how a personalized approach to treating sepsis in the emergency department can improve patient care. Sepsis is a serious condition caused by the body's extreme response to an infection, which can lead to very low blood pressure and organ failure. Traditionally, patients receive a standard amount of fluids to help raise their blood pressure, but this doesn't work for everyone and can sometimes cause complications. In this trial, researchers want to see if giving fluids based on how a patient's heart responds will be safer and more effective.

The study will include adults aged 18 and older who come to the emergency department with suspected sepsis and need immediate treatment to stabilize their blood pressure. Participants will be randomly assigned to either a personalized treatment group, where fluid and medication amounts are adjusted based on heart response, or a standard care group, where fluids are given based on current guidelines. All participants will receive fluids to support their blood pressure. The researchers will monitor various outcomes, such as how much fluid is used, how well patients respond, and how quickly they recover. The hope is that this personalized approach will lead to better care for those suffering from sepsis.

Gender

ALL

Eligibility criteria

• Inclusion 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 \< 36°C or \>38°C, leukocyte count \> 12 x109/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 at ED arrival \[triage\]):
• • Mean arterial pressure (MAP) \< 70 mmHg
• • Systolic blood pressure (SBP) \< 90 mmHg or a SBP decrease \>40 mmHg
• • Lactate \> 4.0 mmol/L
• • Shock index\* \> 0.9
• • Enrolled in study within one hour after ED arrival
• 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, 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.
• • Hemodynamic instability due to active bleeding
• • Patient has received \>1 liter of IV 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
• • Known major lower extremity amputation (proximal to the ankle joint)
• • 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)
• • 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)