Stroke volUme-baSed Fluid resusciTAtIoN in AP (SUSTAIN)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- SIRS Values at the 48 hours after enrollement
研究概览
简要总结
The SUSTAIN Trial is a randomized control trial that allows for the control of aggressive hydration that is currently used in an inpatient setting, which can result is fluid overload in certain patients. With the impression that changes in stroke volume in individual patient will further improve the outcome.
详细描述
The proposed SUSTAIN Trial Study (Stroke volUme-baSed fluid resuscitation), a multi-center randomized controlled trial which will address these knowledge gaps in acute pancreatitis. Recently demonstration from the WATERFALL (Early Weight-Based Aggressive vs. ModeraTE Goal-DiRected Fluid ResuscitAtion) randomized controlled trial that aggressive hydration increased the risk of fluid overload without improving the clinical course of AP compared with a moderate hydration strategy. With further suggestions, rather than a generic body weight-based approach, tailoring fluid requirements to changes in stoke volume in individual patients will further improve outcomes.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients between the age of 18-75
- •Predicted moderate and severe acute pancreatitis, which will be defined by the presence of SIRs, within 24 hours of enrollment
排除标准
- •Patients with the inability to preform a straight leg raise (i.e amputation)
- •Patients with high risk of adverse event related to fluid resuscitation
- •NYHA Class >= II Heart Failure
- •Child's B and C Cirrhosis
- •Dialysis Requirement
- •Clinical signs of hypervolemia, including pulmonary congestion (i.e dyspnea, pulmonary crackles on exam, interstitual edema on imaging) and ascites
- •Ages <18 years old
- •Incarcerated
- •Unable to provide informed consent
研究组 & 干预措施
Group 1: Fluid Resuscitation in Stroke Volume with Leg Raise
We suggest that changes in stroke volume on individual patients can further improve outcomes with fluid resuscitation and prevent fluid overload in the individuals with acute pancreatitis.
干预措施: Lactated Ringers Stroke Volume Based Dosing (Other)
Group 2: Moderate fluid resuscitation per body weight
This arm is based on a past fluid resuscitation study, WATERFALL Study, where there was moderate fluid resuscitation in the setting of treatment for acute pancreatitis.
干预措施: Lactated Ringer's (Other)
结局指标
主要结局
SIRS Values at the 48 hours after enrollement
时间窗: 48 hours
The primary endpoint for this study will be the presence of SIRS at 48 hours from enrollment defined as \>2 SIRS criteria (HR \>90, RR \>20, temperature \>38C or \<36C, and WBC \>12,000 or \<4,000 cells/mm3). SIRS is a marker of disease severity and also may be converted to a SIRS score (number of criterion).
次要结局
- Secondary Clinical Endpoints(Beginning of randomization to 48 hours and between endpoints.)
- Modified pancreatitis activity scoring system (mPASS) score.(From enrollment until 48 hours following enrollment.)
- Complications that arise during the inpatient setting(From enrollment until 30 days after enrollment.)
- Dutch Composite Endpoint(Day 30)
- Participant's Condition during their length of stay (LOS)(From enrollment to 30 days after enrollment.)
- C Reactive protein(Randomization to 48 hours and between timepoints)
- IL-6(Randomization to 48 hours and between timepoints)
- MCP-1(Randomization to 48 hours and between timepoints)
- Resistin(Randomization to 48 hours and between timepoints)
- Angiopoietin-2(Randomization to 48 hours and between timepoints)
- IL-8(Randomization to 48 hours and between timepoints)
- Lactate(Randomization to 48 hours and between timepoints)
研究者
James Buxbaum
Principal Investigator, Clinical Scholar, MD
University of Southern California