Fluid Management and Individualized Resuscitation in Sepsis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 188
- 试验地点
- 2
- 主要终点
- The volume of IV fluids in ml administered within the first three hours after study enrolment.
研究概览
简要总结
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:
- Personalized treatment group: Fluids and vasopressors (medications that raise blood pressure) will be given based on how the heart responds to each fluid dose. This response is measured using a non-invasive monitor that tracks stroke volume index (ΔSVI)-a measure of how much blood the heart pumps.
- Standard care group: Fluids will be given based on current guidelines (30 milliliters per kilogram of body weight), as decided by the treating doctor.
Researchers will compare how much fluid is given during the first 3 hours of care. They will also look at:
- When and how much vasopressor medicine is used
- How well blood pressure and circulation respond
- Signs of organ recovery or damage
- How long participants stay in the hospital
- Any problems or side effects during treatment
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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 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
- •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)
结局指标
主要结局
The volume of IV fluids in ml administered within the first three hours after study enrolment.
时间窗: Up to 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.
次要结局
- Fluid resuscitation(Up to 7 days after hospitalization)
- Length-of-stay in hospital/intensive care unit (ICU)(Until hospital discharge, an average of 2 weeks)
- New onset organ failure(Up to 48 hours after hospitalization)
- Fluid balance(Up to three hours after hospitalization)
- Time to recovery of hemodynamic stability(The time interval from hospital admission until hemodynamic stability, measured in hours.)
- Pre-tibial edema development(Up to 48h after hospitalization)
- Fluid overload at three hours (assessed by Point-of-Care Ultrasound)(Up to three hours after hospitalization)
- Fluid overload at 24h (assessed by Point-of-Care Ultrasound)(Up to 24h after hospitalization)
- Loop diuretic use(Up to 7 days after hospitalization)
- Decompensated heart failure(Up to 7 days after hospitalization)
- Respiratory insufficiency and acute respiratory distress syndrome (ARDS)(Up to 7 days after hospitalization)
- Acute Kidney Injury (AKI within 48 hours)(Up to 48 hours after hospitalization)
- Acute Kidney Injury (AKI within seven days)(Up to 7 days after hospitalization)
- Change in Serum Creatinine Levels (from Baseline to 48 Hours)(From baseline to 48 hours)
- Change in Serum Creatinine Levels (from baseline to 7 days)(From baseline to 7 days)
- Requirement for renal replacement therapy (RRT) within 7 days(Up to 7 days after hospitalization)
- Requirement for renal replacement therapy (RRT) within 30 days(Up to 30 days after hospitalization)
- Major Adverse Cardiac Event (MACE)(Up to 30 days)
- Vasopressor initiation within three hours(Up to three hours)
- Vasopressor initiation within 7 days(Up to 7 days)
- Time to vasopressor initiation(The time interval from hospital admission until the initiation of vasopressor therapy, measured in hours.)
- All-cause mortality (up to 30 days):(Time from hospital admission until death from any cause, up to 30 days)
研究者
Hjalmar Bouma
MD, PhD, EuCP (PI)
University Medical Center Groningen