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临床试验/NCT03477461
NCT03477461已完成不适用

Effects of Terlipressin on Management of Potential Organ Donors:a Retrospective Study

First Affiliated Hospital, Sun Yat-Sen University0 个研究点目标入组 18 人开始时间: 2015年1月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
18
主要终点
creatinine

研究概览

简要总结

During brain death, many significant systemic changes take place and among these, the most notable is hemodynamic instability.

In the pathogenesis of brain death, after the hypertensive phase of the "catecholamine storm", arterial tonus and heart inotropism eventually deteriorate, leading to hypotension and hypoperfusion. Therefore, vasopressor agents are necessary in treatment of brain-dead organ donors. The most commonly used and recommended vasoactive drugs for this indication are dopamine, norepinephrine, and vasopressin.The Transplantation Committee of the American College of Cardiology recommends vasopressin as the primary vasoactive drug for treating hemodynamic instability and diabetes insipidus in brain-death heart donors.

Terlipressin (TP) is a new type of synthetic long-acting vasopressin preparations, AVP long-acting derivatives, belongs to a kind of precursor drugs, itself is inactive, the body through the aminopeptidase, slow "release" of a reactive lysine vasopressin. On the one hand,terlipressin can splanchnic vascular smooth muscle contraction, reduces splanchnic blood flow (e.g., reduce blood flow to the mesenteric, spleen, uterus, etc), to ensure the flow of blood to the important viscera;On the other hand, it reduces the concentration of plasma renin, increases the perfusion of renal blood flow, and improves the glomerular filtration rate, thus improving renal function.From the pharmacological perspective, it is better than arginine vasopressin for the stability of hemodynamics and the perfusion of tissue.

Whether or not it has therapeutic effect on the potential brain death donor with unstable hemodynamics is not studied in the literature at home and abroad.This paper discusses the application value of terlipressin in the management of potential brain death, and provides clinical evidence for the maintenance of brain death donor.

详细描述

Thermodilution cardiac output was measured in triplicate. Hemodynamic parameters were calculated according to standard formulas.Oxygen delivery index (IDO2) was calculated as arterial oxygen content multiplied by CI. Systemic vascular resistance index (SVRI) was calculated as the MAP minus right atrial pressure divided by CI and multiplied by 80. Pulmonary vascular resistance index (PVRI) was calculated as the mean pulmonary artery pressure (PAP) minus pulmonary artery occlusion pressure divided by CI. Left and right ventricular stroke work index (L and RVSWI) were calculated .The following laboratory parameters were collected: bilirubin, aspartate aminotransferase (AST), alanine aminotransferase (ALT),prothrombin time, and thrombocytes.

研究设计

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

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age 10-60 years old, gender is not limited, accord with brain death standard patient.
  • Complete ethical procedures, have entered the donation procedure and successful donation.
  • 3 oliguria or high creatinine.

排除标准

  • Patients with uremia.
  • Patients with diabetes.
  • There is known to be an allergy to trelin.
  • Previous patients with coronary heart disease.
  • Active digestive tract hemorrhage, liver dysfunction (Child C), severe 6.coagulation dysfunction, and cannot be corrected, or other specific contraindication.
  • 7.Active HIV infection or HIV, mental disorder, etc.

研究组 & 干预措施

terlipressin group

patients presented with oliguria or high levels creatinine

干预措施: terlipressin (Drug)

结局指标

主要结局

creatinine

时间窗: Change from Baseline, 24 hours, 72 hours to Before organ procurement

Laboratory values

次要结局

  • urine volume(Change from Baseline, 24 hours, 72 hours to Before organ procurement)
  • glomerular filtration rate(Change from Baseline, 24 hours, 72 hours to Before organ procurement)
  • endogenous creatinine clearance rate(Change from Baseline, 24 hours, 72 hours to Before organ procurement)
  • Norepinephrine dose(Change from Baseline, 24 hours, 72 hours to Before organ procurement)

研究者

发起方
First Affiliated Hospital, Sun Yat-Sen University
申办方类型
Other
责任方
Principal Investigator
主要研究者

GengLong Liu

Principal Investigator

First Affiliated Hospital, Sun Yat-Sen University

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