Fluid Responsiveness After Cardiac Surgery (FRACAS) Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Fluid bolus responsiveness
研究概览
简要总结
Study Design: Prospective observational study
Study Location: Liverpool Hospital Intensive Care Unit, South Western Sydney Local Health District, Sydney, Australia.
Target study size: 100 patients
Ethics: Approved by the local Human Research and Ethics Council (HREC) at Liverpool Hospital (LPOOL) as a Low Negligible Risk (LNR) project [HREC/LNR/14/LPOOL/295, HREC/LNR/15/LPOOL47, HREC/LNR/14/LPOOL/150]
Participants: Post cardiac surgical patients admitted to the Intensive Care Unit between March-October 2016
Aims:
- to determine the descriptive and predictive value of variables (outlined below) related to oxygen delivery/consumption in regards to the effects of intravascular volume expansion
- to assess correlations between central and peripheral variables (outlined below) relevant to oxygen delivery/consumption
- to assess correlations between a set of variables (outline below) and patient centred outcomes in ICU and in hospital
Main variables collected:
- Tissue oxygen saturation by peripheral Near-Infrared Spectroscopy (NIRS)
- Common carotid arterial Doppler
- Arterial/mixed venous/central venous blood gas analyses
- Haemodynamic parameters
- Organ support measures
Data collection time points:
- ICU admission (within 30 minutes)
- Before administration of a fluid bolus
- After administration of a fluid bolus
- 6 hours after ICU admission
- Morning of first postoperative day (12-24 hours)
Outcome measures:
- the response to intravascular volume expansion
- ICU mortality, morbidity and length of stay and hospital mortality and length of stay
Data analysis:
- Clinical data are collected bedside using an electronic case record form
- Descriptive statistics
- Paired and unpaired comparative
- Correlative and predictive statistics
详细描述
This prospective observational study program has a set of objectives within three major domains that will be analysed separately and synergistically:
Peripheral near infra-red spectroscopy (NIRS)
Aims:
- to describe the effects of non-sanguineous intravascular volume expansion on systemic oxygen delivery
- to describe how changes in systemic oxygen delivery impact on peripheral oxygen kinetics as measured by tissue oxygen saturation (StO2) in the thenar and forearm regions at rest and using a vascular occlusion test
- to determine the clinical applicability of using thenar and forearm NIRS to guide haemodynamic optimisation following cardiac surgery
- to assess the relation between systemic and peripheral oxygen kinetics vs. onset of organ dysfunction and need for extended stay in ICU following cardiac surgery
Hypotheses:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Admitted following elective cardiac surgery
- •Adult (>18 years of age)
- •Pulmonary artery, central venous and arterial catheters inserted
排除标准
- •Emergency Patients (surgery immediately or within 12 hours of admission to hospital)
- •Children (< 18 years of age)
- •Patients admitted to ICU with ongoing extracorporeal circulatory support
- •Patients re-admitted to ICU within same index hospital admission
结局指标
主要结局
Fluid bolus responsiveness
时间窗: Approximately 30 minutes
Fluid responsiveness will be determined by any increase in cardiac output (continuous outcome) or by a 10-15% increase in cardiac output (dichotomous outcome) following bolus volume expansion
Volume management responsiveness
时间窗: Approximately 6 hours
Responders will be defined as patients with an improvement (change towards normal physiological values) following cumulative volume expansion in any variable(s) used to assess oxygen delivery/consumption balance
次要结局
- Mortality(Up to 3 months)
- Morbidity(At ICU discharge, an average of 4 days)
研究者
Anders Aneman
Senior Staff Specialist
South West Sydney Local Health District