Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The goal of this clinical trial is to find out if a personalized treatment approach can improve care for people with sepsis in the emergency department (ED).
Sepsis is a life-threatening condition that happens when the body has an uncontrolled response to an infection. This can lead to low blood pressure, organ failure, and death if not treated quickly. Right now, most people with sepsis receive a standard amount of fluids to raise their blood pressure. But this one-size-fits-all approach can lead to fluid overload and other complications. Because each person responds differently, this study will test whether a more personalized treatment-based on how the heart responds to fluids-can lead to safer and more effective care.
The study will include 188 adults who come to the ED at the University Medical Centre Groningen (UMCG) with suspected sepsis in need of hemodynamic resuscitation. Everyone in the study will receive fluids to support their blood pressure.
Participants will be randomly assigned to one of two groups:
Researchers will compare how much fluid is given during the first 3 hours of care. They will also look at:
The researchers hope that this personalized approach will lead to using less fluid, starting vasopressors earlier, and helping people with sepsis recover more safely and quickly.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Personalized SV-Guided Resuscitation | Experimental |
| |
| Standard Care Resuscitation | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Personalized SV-guided resuscitation | Other | Participants will receive an IV fluid bolus directly after inclusion. Next, measurement of the cardiac output change in response to the fluid bolus by the Starling SV will be used to determine fluid responsiveness. Vital parameters and fluid responsiveness will be used to guide hemodynamic resuscitation, consisting of IV fluids and/or vasopressors, during the first 3 hours. |
| Measure | Description | Time Frame |
|---|---|---|
| The volume of IV fluids in ml administered within the first three hours after study enrolment. | The primary endpoint is the volume of IV fluids in ml administered within the first three hours after study enrolment. | Up to three hours, after study enrolment. |
| Measure | Description | Time Frame |
|---|---|---|
| Length-of-stay in hospital/intensive care unit (ICU) | Length-of-stay in hospital and on intensive care unit (ICU) in days | Until hospital discharge, an average of 2 weeks |
| New onset organ failure |
| Measure | Description | Time Frame |
|---|---|---|
| Cost-effectiveness | Evaluation of cost-effectiveness based on hospital length of stay, requirement for advanced care, and costs associated with diagnostic and monitoring measurements. | Up to 30 days after hospitalization |
| Starling SV monitor trends |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sanne Ter Horst, MD | Contact | +31 6 25650284 (FLUIDS phone) | s.ter.horst@umcg.nl | |
| Sanne Ter Horst, MD | Contact | s.ter.horst@umcg.nl |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Centre Groningen | Recruiting | Groningen | Provincie Groningen | 9713GZ | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41417807 | Derived | Ter Horst S, Ter Avest E, van Everdink J, van Meurs M, Olgers TJ, Vos JJ, Damman K, Ter Maaten JC, Bouma HR. FLUid management and InDividualized resuscitation in Sepsis (FLUIDS)-A Study protocol for a single-centre, open-label, randomized clinical trial. PLoS One. 2025 Dec 19;20(12):e0338504. doi: 10.1371/journal.pone.0338504. eCollection 2025. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D018805 | Sepsis |
| D012769 | Shock |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Standard Care Resuscitation | Other | In the control group, IV fluid and vasopressor administration will be determined at the discretion of the physician and in accordance with currently available guidelines (e.g. Sepsis Surviving Campaign). |
|
Any of the following within 48 hours:
| Up to 48 hours after hospitalization |
| Fluid balance | Net fluid balance calculated as the total volume of fluids administered (intravenous and oral, including prehospital) minus the total volume of fluid output (urine and other measurable losses) within the first three hours after ED presentation | Up to three hours after hospitalization |
| Fluid resuscitation | Volume of IV fluid resusciation within 7 days | Up to 7 days after hospitalization |
| Time to recovery of hemodynamic stability | Hemodynamic stability (HDS) is defined as MAP ≥ 70 mmHg, SBP ≥ 90 mmHg, lactate ≤ 4 mmol/L and SI ≤ 0.9. | The time interval from hospital admission until hemodynamic stability, measured in hours. |
| Pre-tibial edema development | Pre-tibial edema rise of ≥ 2 (grade 1-4), measured at triage, after 3h, 24h and 48h | Up to 48h after hospitalization |
| Fluid overload at three hours (assessed by Point-of-Care Ultrasound) | Venous congestion is assessed using Point-of-Care Ultrasound (PoCUS) at three hours after hospital admission. The PoCUS evaluation includes measurements of the Inferior Vena Cava (IVC), the Venous Excess Ultrasound (VExUS) score, and assessment following the Bedside Lung Ultrasound in Emergency (BLUE) protocol. | Up to three hours after hospitalization |
| Fluid overload at 24h (assessed by Point-of-Care Ultrasound) | Venous congestion is assessed using Point-of-Care Ultrasound (PoCUS) at 24 hours after hospital admission. The PoCUS evaluation includes measurements of the Inferior Vena Cava (IVC), the Venous Excess Ultrasound (VExUS) score, and assessment following the BLUE protocol. | Up to 24h after hospitalization |
| Loop diuretic use | Loop diuretic use will be determined daily and retrieved from the electronic health records (EHR) of the hospital, general practitioner, and pharmacy. | Up to 7 days after hospitalization |
| Decompensated heart failure | Occurrence of decompensated heart failure within 7 days after admission, as determined by the clinical judgment of the treating physician. | Up to 7 days after hospitalization |
| Respiratory insufficiency and acute respiratory distress syndrome (ARDS) | ARDS is defined as the presence of any of the following within 7 days after admission:
| Up to 7 days after hospitalization |
| Acute Kidney Injury (AKI within 48 hours) | AKI is defined according to the KDIGO criteria and assessed within the first 48 hours after admission. | Up to 48 hours after hospitalization |
| Acute Kidney Injury (AKI within seven days) | AKI is defined according to the KDIGO criteria and assessed within the first seven days after admission. | Up to 7 days after hospitalization |
| Change in Serum Creatinine Levels (from Baseline to 48 Hours) | The difference in serum creatinine concentration measured at baseline and at 48 hours after admission. | From baseline to 48 hours |
| Change in Serum Creatinine Levels (from baseline to 7 days) | The difference in serum creatinine concentration measured at baseline and at 7 days after admission. | From baseline to 7 days |
| Requirement for renal replacement therapy (RRT) within 7 days | Initiation of renal replacement therapy (e.g., hemodialysis, continuous renal replacement therapy) within 7 days after hospital admission, as determined from electronic health care records. | Up to 7 days after hospitalization |
| Requirement for renal replacement therapy (RRT) within 30 days | Initiation of renal replacement therapy (e.g., hemodialysis, continuous renal replacement therapy) within 30 days after hospital admission, as determined from electronic health care records. | Up to 30 days after hospitalization |
| Major Adverse Cardiac Event (MACE) | Occurrence of any of the following events within 30 days after admission:
| Up to 30 days |
| Vasopressor initiation within three hours | Start of vasopressor therapy within the first three hours after hospital admission. | Up to three hours |
| Vasopressor initiation within 7 days | Start of vasopressor therapy within the first 7 days after hospital admission. | Up to 7 days |
| Time to vasopressor initiation | The duration between hospital admission and the initiation of vasopressor treatment. | The time interval from hospital admission until the initiation of vasopressor therapy, measured in hours. |
| All-cause mortality (up to 30 days): | Mortality will be retrieved from the electronic health records (EHR) from the hospital and municipal registration. The cause of death will be retrieved from the EHR from the hospital. | Time from hospital admission until death from any cause, up to 30 days |
Continuous monitoring and recording of stroke volume index (SVI), cardiac index (CI), and total peripheral resistance index (TPRI) trends using the Starling SV device throughout the fluid resuscitation period in the intervention group.
| Up to three hours after hospitalization |
| Hemodynamic parameter trends | Measurement of hemodynamic parameters, including systolic blood pressure, diastolic blood pressure, mean arterial pressure, heart rate, lactate levels, and capillary refill time, during resuscitation period, recorded up to three hours after arrival at the emergency department. | Up to three hours after hospitalization |
| Photoplethysmographic (PPG) waveform trends | Measurement of photoplethysmography (PPG) waveform features, including systolic and diastolic peak amplitudes, pulse interval and perfusion index, recorded continuously during the emergency department stay, up to three hours after arrival. | Up to three hours after hospitalization |
| Electrocardiography (ECG) waveform trends | Measurement of Electrocardiography (ECG) waveform features, including pulse transit time (PTT) and heart rate variability (HRV), recorded continuously during the emergency department stay, up to three hours after arrival. | Up to three hours after hospitalization |
| D013568 |
| Pathological Conditions, Signs and Symptoms |