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临床试验/NCT06930443
NCT06930443招募中不适用

Oxygen Consumption, Early Postoperative Hypoperfusion and Organ Injury After Cardio-pulmonary Bypass: a Prospective Observational Study

Uppsala University Hospital1 个研究点 分布在 1 个国家目标入组 65 人开始时间: 2025年5月5日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
65
试验地点
1
主要终点
Difference in oxygen consumption in early postoperative hypoperfusion

研究概览

简要总结

The goal of this observational study is to understand how oxygen consumption after heart surgery relates to blood flow problems and organ injury. The study focuses on patients over 18 years old who are having planned heart surgery with a heart-lung machine (cardiopulmonary bypass).

The main questions the study aims to answer are:

  1. How does oxygen consumption in the early hours after surgery relate to lactate levels (a sign of low oxygen supply to the tissues)?
  2. How is oxygen consumption linked to signs of poor blood flow and organ injury (such as heart, kidney, liver, brain, and gut damage)?

Researchers will measure oxygen consumption after surgery using a technique called indirect calorimetry. They will also track blood flow and oxygen use during surgery and check for signs of organ injury the day after the procedure. The study will include 65 participants. People with certain health conditions, like severe anemia, high lactate levels before surgery, or needing intensive care or extra oxygen supply before surgery, will not be included. By understanding how oxygen consumption relates to blood flow and organ injury, this research may help to better manage patients after heart surgery and reduce complications.

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

入选标准

  • Elective cardiac surgery requiring cardiopulmonary bypass

排除标准

  • Combined, redo or annuloplasty procedures
  • Surgical procedures involving other vascular cannulation than standard direct, such as bicaval or femoral cannulation
  • Preoperative hyperlactatemia (>2mmol/L) or anaemia (Hb <90 g/dL)
  • Preoperative need for supplementary oxygen or ICU care
  • Consent not obtainable.

结局指标

主要结局

Difference in oxygen consumption in early postoperative hypoperfusion

时间窗: 0-4 hours after surgery

Difference in oxygen consumption (VO2I via indirect calorimetry) in ml min-1 m-2 between patients with and without early hyperlactatemia (\>2mmol/L)

次要结局

  • Evaluation of hypoperfusion parameters as predictors of postoperative oxygen consumption(0-24 hours after surgery)
  • Evaluation of oxygen delivery and consumption during cardiopulmonary bypass as predictors of postoperative oxygen consumption(0-4 hours during and after surgery)
  • Evaluation of organ injury biomarkers as predictors of postoperative oxygen consumption(Preoperative and the day after surgery)

研究者

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

Julia Jakobsson

MD, PhD, Consultant Cardiothoracic anaesthesia and intensive care

Uppsala University Hospital

研究点 (1)

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