Randomized Control Study on Normal Saline vs Plasmalite vs Plasma in REsuscitation of SEpsis Trial (RESET) - A Feasibility and Comparative Study
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Feasibility in terms of efficacy and safety of crystalloids versus synthetic fresh plasma as the initial resuscitation fluid in children presenting with septic shock: Rate of Signed Informed Consent
研究概览
简要总结
Crystalloids vs. Synthetic Plasma for Fluid Resuscitation in Children with Sepsis - REsuscitation of SEpsis Trial (RESET): A Comparative and Feasibility Study This research study, called the REsuscitation of SEpsis Trial (RESET), is a randomized clinical trial comparing crystalloids and synthetic plasma for fluid resuscitation in children with sepsis. Below, we explain some key aspects you should be aware of.
What is a Clinical Trial? A clinical trial is a type of medical research designed to gather more information on how our bodies respond to medications or other treatments.
Most new medical treatments must be evaluated in clinical trials before they can be approved by government agencies. These agencies ensure that new treatments are not only safe but also beneficial for patients-what medicine refers to as being "safe and effective." If a new treatment has not yet been approved, it is considered "experimental."
Researchers analyze the results of multiple clinical trials to determine which medications work best and how they function. The advancement of medical science requires the participation of many people in numerous studies worldwide.
What is the Purpose of This Study? This study evaluates whether Octaplas LG helps children and adolescents with sepsis and whether it improves the function of blood vessels inflamed due to infection. Sepsis occurs when an infection severely affects a person's health.
Octaplas LG is a medication approved for use in Colombia. It is known as pharmaceutical plasma and is obtained from voluntary donors worldwide. It undergoes an ultra-detailed sterilization process using the most advanced techniques for processing blood derivatives. In medicine, fresh frozen plasma (FFP) is typically used, which is the equivalent of Octaplas LG but with far fewer industrial sterilization processes. These additional processes in Octaplas LG significantly reduce the risk of transmitting infections.
Although Octaplas LG is approved by INVIMA, its use for fluid resuscitation has not yet been approved.
This study will compare Octaplas LG with normal saline solution and Ringer's lactate, which are commonly used for rehydrating patients. All three treatments will be administered in the same manner.
Why is My Child Being Asked to Participate?
Your child is being invited to participate in this clinical study because:
They are receiving care in the pediatric intensive care unit (PICU). They are between one month and 18 years old. They have been diagnosed with sepsis and require fluid resuscitation. Your child's participation is voluntary. If you decide not to participate, your child will not lose any medical benefits. Your child's doctor has determined that they may be a good candidate for this study. You are free to discuss participation with your family, friends, or another physician.
Some members of your child's healthcare team may also be involved in this research. They are dedicated to your child's care as well as the objectives of this study. However, you are not obligated to participate. If you choose to enroll your child, you will be asked to sign an informed consent form.
How Will My Child Be Assigned to a Treatment Group? Upon admission to the pediatric intensive care unit (PICU), if your child has a confirmed sepsis diagnosis and requires intravenous fluids or plasma to support heart function, they will be randomly assigned to one of the three treatment groups.
Randomization is a research method used in clinical trials to assign patients to study groups in an unbiased way-similar to drawing numbers from a hat. Neither you, your child's doctor, nor the researchers will choose which group your child is placed in. Instead, a computer will randomly assign them to a group.
Treatment Groups:
Group 1: Normal Saline (0.9% Sodium Chloride)
Your child will receive the standard treatment for sepsis, including antibiotics, intravenous fluids, heart function monitoring, mechanical ventilation if needed, and blood pressure medications (vasopressors) if necessary.
Group 2: Ringer's Lactate
In addition to standard sepsis management, your child will receive Ringer's lactate, another commonly used resuscitation fluid in pediatric sepsis.
Group 3: Octaplas LG
In addition to standard sepsis management, your child will receive pharmaceutical synthetic plasma, which contains proteins and essential blood components that have undergone advanced processing to eliminate the risk of infectious disease transmission.
How Many Children Will Participate in This Study? At Fundación Cardioinfantil-Instituto de Cardiología, we are seeking the participation of approximately 150 children in this study.
How Long Will My Child Be in the Study? Your child will remain in their assigned treatment group for up to 28 days from PICU admission or until they no longer require intensive care hospitalization.
详细描述
Protocol Title: Randomized Clinical Trial Comparing Crystalloids vs. Synthetic Plasma for Fluid Resuscitation in Children with Sepsis - REsuscitation of Sepsis Trial (RESET): Feasibility and Comparative Study
Development Phase: Phase IV Study
Sponsor:
Fundación Cardioinfantil - Instituto de Cardiología Children's Hospital of Pittsburgh - Center for Trauma and Transfusion Medicine Research, University of Pittsburgh, Pittsburgh, USA
Medical Sponsor and International Coordinator Dr. Jaime Fernández - Pediatric Intensivist, Head of the Pediatric Intensive Care Unit, Fundación Cardioinfantil, Bogotá, Colombia Dr. Phillip Spinella, MD, FCCM - Pediatric Intensivist, Department of Surgery and Anesthesia, Children's Hospital of Pittsburgh; Emeritus Professor, Department of Surgery and Critical Care, University of Pittsburgh; Director, Center for Trauma and Transfusion Medicine Research, University of Pittsburgh, Pittsburgh, USA
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
- 4 Weeks 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Receipt of ≥2 boluses of NS 0.9% or balanced solution in the last 24 hours for the current sepsis episode (bolus defined as ≥10 mL/kg (max. 500 mL) of NS/RL given in <30 min).
- •Known allergic reaction to plasma-derived products.
- •Known IgA deficiency.
- •Suspected or confirmed congestive heart failure.
- •Nephrotic syndrome.
- •Known chronic kidney disease with fluid overload or congestive heart failure.
- •Diagnosed hemorrhagic dengue fever confirmed by antigen or serology (NS1 or IgM positive).
研究组 & 干预措施
OCTAPLAS LG
Pharmaceutical fresh frozen plasma (OCTAPLAS LG®), bolus dose of 10 mL/kg (max. 500 mL) administered over <15 minutes
干预措施: Pharmaceutical fresh frozen plasma (Biological)
Normal saline
Bolus dose of 10 mL/kg normal saline (NS) (max. 500 mL) administered over <15 minutes.
干预措施: Normal Saline (Drug)
Ringer Lactate
Bolus dose of 10 mL/kg Ringer's lactate (max. 500 mL) administered over <15 minutes.
干预措施: Ringer lactate (RL) (Drug)
结局指标
主要结局
Feasibility in terms of efficacy and safety of crystalloids versus synthetic fresh plasma as the initial resuscitation fluid in children presenting with septic shock: Rate of Signed Informed Consent
时间窗: Within the first 2 hours after presentation to the PICU. Percentage (%)
Proportion of patients for whom signed informed consent is obtained prior to the intervention.
Feasibility in terms of efficacy and safety of crystalloids versus synthetic fresh plasma as the initial resuscitation fluid in children presenting with septic shock: Time to Plasma Administration
时间窗: Within the first 24 hours after admission. Minutes (min)
Time elapsed from clinical indication to administration of the assigned plasma product.
Feasibility in terms of efficacy and safety of crystalloids versus synthetic fresh plasma as the initial resuscitation fluid in children presenting with septic shock: Follow-up Rate
时间窗: From PICU admission until day 28 or PICU discharge. Percentage (%)
Proportion of patients with complete follow-up until PICU discharge or day 28, whichever comes first.
Feasibility in terms of efficacy and safety of crystalloids versus synthetic fresh plasma as the initial resuscitation fluid in children presenting with septic shock: Ability to Obtain and Process Biological Samples
时间窗: During the first 24 hours post-intervention. Percentage (%)
Percentage of biological samples (for clinical laboratory tests, inflammatory markers, and endothelial biomarkers) successfully collected and processed according to protocol.
Feasibility in terms of efficacy and safety of crystalloids versus synthetic fresh plasma as the initial resuscitation fluid in children presenting with septic shock: Incidence of Clinical Outcomes
时间窗: Up to 28 days post-intervention or until PICU discharge. Number of events (n), Percentage (%)
Incidence of clinical outcomes such as mechanical ventilation, inotropic support, multiple organ dysfunction, or mortality.
Efficacy of crystalloids versus synthetic fresh plasma as the initial resuscitation fluid in children presenting with septic shock in clinical variables and supports: Oxygenation as Assessed by PaO₂/FiO₂ Ratio
时间窗: Within the first 24 hours of intervention. Ratio (unitless)
Evaluation of oxygenation using the PaO₂/FiO₂ ratio.
Efficacy of crystalloids versus synthetic fresh plasma as the initial resuscitation fluid in children presenting with septic shock in clinical variables and supports: Oxygenation Index (OI)
时间窗: Within the first 24 hours of intervention. Unitless value
Oxygenation Index calculated as (FiO₂ × MAP / PaO₂) × 100.
Efficacy of crystalloids versus synthetic fresh plasma as the initial resuscitation fluid in children presenting with septic shock in clinical variables and supports: Intravascular Volume Status
时间窗: Within the first 24 hours of intervention. Categorized as improved / no change / worsened (qualitative)
Assessment of intravascular volume status based on clinical and hemodynamic parameters.
Efficacy of crystalloids versus synthetic fresh plasma as the initial resuscitation fluid in children presenting with septic shock in clinical variables and supports: Inotropic Score
时间窗: Maximum value during the first 24 hours post-intervention. Inotropic score (numeric)
Quantification of cardiovascular support based on standard inotropic scoring systems.
Efficacy of crystalloids versus synthetic fresh plasma as the initial resuscitation fluid in children presenting with septic shock in clinical variables and supports: Endothelial Injury Markers
时间窗: Baseline and within 24 hours post-intervention. ng/mL
Measurement of circulating endothelial biomarkers such as syndecan-1, angiopoietin-2, or others defined in protocol.
Efficacy of crystalloids versus synthetic fresh plasma as the initial resuscitation fluid in children presenting with septic shock in clinical variables and supports: Hemostatic Measures
时间窗: Baseline and within 24 hours post-intervention. Seconds (for PT/aPTT), mg/dL or ng/mL (as applicable)
Evaluation of coagulation parameters including PT, aPTT, fibrinogen, and D-dimer levels.
Efficacy of crystalloids versus synthetic fresh plasma as the initial resuscitation fluid in children presenting with septic shock in clinical variables and supports: Incidence of New or Progressive Organ Failure
时间窗: Up to 28 days post-intervention or until PICU discharge. Number of patients (n), Percentage (%)
Number of patients with new or worsening organ dysfunction during hospitalization.
Efficacy of crystalloids versus synthetic fresh plasma as the initial resuscitation fluid in children presenting with septic shock in clinical variables and supports: 28-Day All-Cause Mortality
时间窗: Up to day 28. Number of deaths (n), Percentage (%)
Death from any cause within 28 days of randomization.
Efficacy of crystalloids versus synthetic fresh plasma as the initial resuscitation fluid in children presenting with septic shock in clinical variables and supports: Cause of Death
时间窗: Up to 28 days post-randomization. Categorical (by cause)
Categorization of causes of death (e.g., refractory shock, respiratory failure, neurologic injury).
次要结局
- Compare hemodynamic parameters using continuous non-invasive cardiac output monitoring (iCON®) between groups: Cardiac Output (CO)(During the 24-hour intervention period. Liters per minute (L/min))
- Compare hemodynamic parameters using continuous non-invasive cardiac output monitoring (iCON®) between groups: Cardiac Index (CI)(During the 24-hour intervention period. Liters per minute per square meter (L/min/m²))
- Compare hemodynamic parameters using continuous non-invasive cardiac output monitoring (iCON®) between groups: Systemic Vascular Resistance (SVR)(During the 24-hour intervention period. dyn·s/cm⁵)
- Compare hemodynamic parameters using continuous non-invasive cardiac output monitoring (iCON®) between groups: Stroke Volume Variability (SVV)(During the 24-hour intervention period. Percentage (%))
- Compare hemodynamic parameters using continuous non-invasive cardiac output monitoring (iCON®) between groups: Pulse Pressure Variation (PPV)(During the 24-hour intervention period. Percentage (%))
- Total Volume of Resuscitation Fluid Administered Within the First 6, 24, and 48 Hours(At 6, 24, and 48 hours after admission. Milliliters (mL))
- Evaluate endothelial injury markers and hemostatic parameters, and assess inflammatory markers and coagulation activation measures: Plasma Concentration of IL-1 at 0, 6, and 24 Hours(0, 6, and 24 hours after fluid administration. pg/mL)
- Evaluate endothelial injury markers and hemostatic parameters, and assess inflammatory markers and coagulation activation measures: Plasma Concentration of IL-10 at 0, 6, and 24 Hours(0, 6, and 24 hours. pg/mL)
- Evaluate endothelial injury markers and hemostatic parameters, and assess inflammatory markers and coagulation activation measures: Plasma Concentration of IL-6 at 0, 6, and 24 Hours(0, 6, and 24 hours. pg/mL)
- Evaluate endothelial injury markers and hemostatic parameters, and assess inflammatory markers and coagulation activation measures: Plasma Concentration of TNF-alpha at 0, 6, and 24 Hours(0, 6, and 24 hours. pg/mL)
- Evaluate endothelial injury markers and hemostatic parameters, and assess inflammatory markers and coagulation activation measures: Plasma Concentration of Syndecan-1 at 0, 6, and 24 Hours(0, 6, and 24 hours. ng/mL)
- Evaluate endothelial injury markers and hemostatic parameters, and assess inflammatory markers and coagulation activation measures: Plasma Concentration of Soluble E-selectin (sE-selectin)(0, 6, and 24 hours. ng/mL)
- Evaluate endothelial injury markers and hemostatic parameters, and assess inflammatory markers and coagulation activation measures: Plasma Concentration of Thrombomodulin(0, 6, and 24 hours. ng/mL)
- Evaluate endothelial injury markers and hemostatic parameters, and assess inflammatory markers and coagulation activation measures: Plasma Concentration of VEGF and VEGFR-1(0, 6, and 24 hours. pg/mL)
- Evaluate endothelial injury markers and hemostatic parameters, and assess inflammatory markers and coagulation activation measures: Plasma Concentration of Coagulation Activation Markers (TAT Complexes, PF-1, PF-2)(0, 6, and 24 hours. ng/mL)
- Safety endpoints, transfusion reactions: Number of Participants with Transfusion-Related Acute Lung Injury (TRALI)(Within 24 hours of intervention. Number of participants)
- Safety endpoints, transfusion reactions: Number of Participants with Transfusion-Associated Circulatory Overload (TACO)(Within 24 hours of intervention. Number of participants)
- Safety endpoints. Transfusion reactions: Number of Participants with Febrile Non-Hemolytic Transfusion Reactions(Within 24 hours of intervention. Number of participants)
- Safety endpoints, transfusion reactions: Number of Participants with Allergic Transfusion Reactions(Within 24 hours of intervention. Number of participants)