跳至主要内容
临床试验/NCT06292910
NCT06292910已完成不适用

Predictability of Central Venous to Arterial CO2 Difference (AVCO2) in Children With Cardiac Surgery to Poor Outcomes

Prince of Songkla University1 个研究点 分布在 1 个国家目标入组 136 人开始时间: 2021年8月8日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
136
试验地点
1
主要终点
number of participant who developed low cardiac output syndrome related poor outcomes within 24 hour post operation

研究概览

简要总结

The goal of this clinical trial is to compare the capability of 3 different bedside surrogates in children who underwent cardiac surgery and were admitted in intensive care unit. These test are lactate, oxygen saturation from central venous and the carbon dioxide gap between central venous and arterial.

The main questions is which one is the best prognostication for post operation poor outcomes Participants will be taken routine blood test for post cardiac care (at ICU arrival, 6, 12, and 24 hour post operation) and follow the their outcomes. There is no any intervention or drug in this research

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
1 Day 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Children aged 0-18 years old with either congenital or acquired cardiac disease
  • Undergone cardiopulmonary bypass for cardiac surgery
  • Be admitted in PICU for post-operative care

排除标准

  • Preterm infant (GA < 37 weeks) or weight less than 2 kg
  • Patient who weaned off cardiopulmoanry bypass and required extracorporeal membrane oxygenator (ECMO) before leaving the operating room
  • Patient who required emergency cardiac operation within 24 hour after hospitalization
  • Patient who had significant residual left side outflow tract obstruction (e.g., coarctation of aorta, interrupted aortic arch) which defined by difference of SBP between upper and lower extremities more than 10 mmHg
  • Patient who had already participated in another research project
  • Patient who does not have both arterial line and central line catheter back from operating room
  • Parents or legal guardian refuse to inform consent.

结局指标

主要结局

number of participant who developed low cardiac output syndrome related poor outcomes within 24 hour post operation

时间窗: from time of subject was admitted to ICU until the 24 hour post operation

the low cardiac output syndrome (LCOS) related poor outcomes was diagnosed if at least two of the following criteria were met within 24 hours postoperatively: 1. clinical LCOS: prolonged capillary refill \>3 seconds, systolic blood pressure \<5th percentile for age and sex, persistent elevation of left atrial pressure \>10 mmHg for at least 6 hours, and low urinary output (\<1 mL/kg/hour) for at least 6 hours despite diuretic use 2. laboratory LCOS: persistently elevated lactate level (\>2 mmol/L), metabolic acidosis with an increase in the base deficit (\>4 mmol/L) for at least 6 hours consecutively 3. Vasoactive-inotropic score ≥20 4. any unplanned surgery or intervention, cardiac arrest, or utilization of ECMO 5. left ventricular fraction \<50% on echocardiography

次要结局

  • ventilator days(from date of subject was admitted to ICU until the date of subject was extubated, assessed up to 28 days)
  • length of stay in ICU(from date of subject was admitted to ICU until the date of subject was discharge, assessed up to 28 days)
  • inotrope days(from date of subject was admitted to ICU until the date of subject was free of inotropic drugs, assessed up to 28 days)

研究者

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

Pharsai Prasertsan

Assist. Prof

Prince of Songkla University

研究点 (1)

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