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临床试验/NCT05070819
NCT05070819已完成不适用

Role of Atrial Natriuretic Peptide in Assessing of Fluid Status in Cardiac Surgery Patients

Petrovsky National Research Centre of Surgery1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2021年9月23日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
1
主要终点
Number of Patients With Pro-ANP Twofold Raise by the End of Surgery

研究概览

简要总结

Biomarkers can play a significant role in fluid status assessment intraoperatively.

详细描述

Routinely intraoperatively the fluid status assessment is based on central venous pressure and other parameters. Nevertheless, the minority of anesthesiologists use continous dynamic parameters like pulse pressure variation, stroke volume variation and other to manage fluid status. There's a fast acting biomarker that can help anesthesiologist to diagnose and manage the volemic status and possibly guide the infusion therapy better.

Pro-ANP is a biomarker that reacts on atria strain and can be used in volemic status assessment in cardiac surgery patients.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
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

  • •CABG, one-, two valve repair/replacement, ascending aorta, aortic arch replacement, ASD/AVD closure, septal myectomy

排除标准

  • •Atrial fibrillation, atrial flutter, frequent ventricular and supraventricular arrythmias
  • •EFLV < 50%
  • •Pulmonary hypertension > 2 st
  • •CKD > C3 (GFR < 30)
  • •Redo surgery
  • •Left atrium volume > 150 ml
  • •LV EDV > 250 ml

研究组 & 干预措施

Cardiac surgery patients

Experimental
  1. After admission to OR and arterial catheter is placed the pro-ANP probe is obtained.
  2. After anesthesia induction, trachea intubation before Teboul' test pro-ANP is obtained
  3. At the end of Teboul' test when lower limbs are lifted
  4. 30 minutes of CPB
  5. End of CPB
  6. End of volume transition from CPB circuit to patient
  7. Before Teboul' test at the end of surgery
  8. End of Teboul' test when lower limbs are lifted

干预措施: pro-ANP (Diagnostic Test)

结局指标

主要结局

Number of Patients With Pro-ANP Twofold Raise by the End of Surgery

时间窗: intraoperatively

To assess the atria strain and consequent rise of pro-ANP by the end of surgery

Number of Patients With Pro-ANP Increase > 10% by the PLR Maneuver

时间窗: intraoperative

According to positive PLR the assessment of pro-ANP consequent raise

Number of Patients With Cardiac Index Rise > 10% After Passive Leg Raising Maneuver

时间窗: 10 minutes of PLR test

Using Massimo vigileo hard- and software the first assessment of cardiac index was made before Teboul test after the trachea intubation. After 10 minutes of passive leg raising maneuver second assessment. If raise in cardiac index above 10 percent was detected the patient was considered a responder. If not - non-responder.

Number of Patients With Pro-ANP Increase > 10% by the PLR Maneuver at the End of Surgery

时间窗: 10 minutes of PLR test

Using Massimo vigileo hard- and software the assessment of cardiac index was made before Teboul test at the end of surgery before leaving the operating room. After 10 minutes of passive leg raising maneuver second assessment. If raise in cardiac index above 10 percent was detected the patient was considered a responder. If not - non-responder.

次要结局

  • Multiorgan Failure(up to 10 days)
  • Respiratory Failure(up to 10 days)
  • Renal Failure(up to 10 days)
  • Heart Failure(up to 10 days)
  • Circulatory Insufficiency(up to 10 days)
  • Postoperative Complications(up to 10 days)
  • Mortality(up to 10 days)
  • Infection Rate(up to 10 days)
  • Length of Intensive Care Stay(up to 10 days)

研究者

发起方
Petrovsky National Research Centre of Surgery
申办方类型
Other
责任方
Sponsor

研究点 (1)

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