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临床试验/NCT02641119
NCT02641119已完成不适用

Association of Resuscitation Fluid Choice and Clinical Outcomes in Critically Ill Patients

University of Pittsburgh0 个研究点目标入组 65,800 人开始时间: 2014年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
65,800
主要终点
Mortality

研究概览

简要总结

This observational study evaluates the potential benefits, costs and clinical outcomes of albumin over saline and other non-saline fluids in patients receiving large volume resuscitation.

详细描述

Currently, recommended resuscitation paradigms involve a "crystalloid-first" approach. This approach reserves more potent and potentially more toxic colloids for patients that have already been exposed to large amounts of crystalloid and may have also experienced a delay in correcting their shock.

This observational retrospective cohort study aims to identify predictors for large volume resuscitation (LVR) and model the potential benefits, costs and clinical outcomes of albumin over saline and other non-saline fluids in patients receiving large volume resuscitation. Further analyses will assess the risk of acute kidney injury (AKI) and hyperchloremic metabolic acidosis (HCA) associated with resuscitation fluid choice and examine long term outcomes such as development of end stage renal disease and post-discharge mortality up to 1 year following hospital discharge in patients treated with various fluid types

This study will utilize data in a large, heterogeneous cohort (n=~65,800) of critically ill patients admitted to the ICU over a 12 year period at the University of Pittsburgh Medical Center. The study population will consist of patients who receive large volume resuscitation (defined as > 60ml/kg in a single 24 hour period) separated into analysis groups based on fluids administered during the defined 24 hour large volume resuscitation window. Patients presenting with AKI or HCA prior to large volume resuscitation will be excluded. AKI and "Severe" AKI will be diagnosed based on KDIGO criteria within 72 hours following LVR. Metabolic acidosis will be based on arterial blood gas measurements with a base deficit > 2 mEq/l, with patients having chloride as the ion contributing to the majority of the acidosis being diagnosed with Hyperchloremic metabolic acidosis. Mortality at 30, 90, and 365-days from ICU admission will be ascertained using the social security death master file. Propensity score models will be used to determine the adjusted relationship between these clinical outcomes and type of fluid resuscitation employed.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Critically ill patient admitted to ICU

排除标准

  • History of chronic dialysis and/or renal transplant
  • Baseline serum creatinine >= 4 mg/dl
  • Develop AKI or MA prior to LVR
  • Received OR fluids during LVR

结局指标

主要结局

Mortality

时间窗: Prior to hospital discharge. Expected length of inpatient stay is 30 days.

Number of patients who die prior to hospital discharge

次要结局

  • Mortality(1 year from ICU admission)
  • Development of Acute Kidney Injury (AKI)(Within 72 hours following large volume resuscitation)
  • Development of Hyperchloremic metabolic acidosis(Within 24 hours following large volume resuscitation)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

John Kellum

Director, Center for Critical Care Nephrology; Professor, Critical Care Medicine

University of Pittsburgh

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