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临床试验/NCT05068713
NCT05068713已完成3 期

High Versus Low Blood-Pressure Target in the Post Operative Care of Liver Transplantation

University of Sao Paulo General Hospital2 个研究点 分布在 1 个国家目标入组 174 人开始时间: 2021年8月24日最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
入组人数
174
试验地点
2
主要终点
incidence of Acute Kidney Disfunction

研究概览

简要总结

LIVER PAM

A randomized, controled, open and unicentric trial comparing high (MAP 85-90 mmHg) and low (65-70 mmHg) target of mean arterial pressure in the first 24 hours after liver transplantation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

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

  • Older than 18 y
  • Admitted in the ICU for a post operative care after liver transplant

排除标准

  • Consent refusal
  • Liver transplant due to acute liver failure
  • Renal transplant ( Previous or concomitant)
  • Refusal from the healthcare provider responsible for the patient
  • Renal substitution therapy in the prior 15 days
  • Pregnancy
  • Re-Transplant (Liver transplant in the previous 6 month)
  • Hepatorenal syndrome current treatment (Use of terlipressin + Albumin)
  • Refractory and persistent shock during or after transplant

结局指标

主要结局

incidence of Acute Kidney Disfunction

时间窗: 7 days

Incidence of acute kidney Disfunction according to kdigo criteria.

次要结局

  • Days alive and out of hospital in 28 days(28 days)
  • re-transplant(28 days)
  • Lenght of Hospitay Stay(28 days)
  • Substitutive Renal Therapy(7 days)
  • MAKE28(28 days)
  • Mortality(28 days)
  • Need of Transfusion(7 days)
  • Postoperative Major bleeding in 7 days(7 days)
  • Days Alive and free of renal disfunction(28 days)
  • Acute kidney insufficiency according to Urinary NGAL on d0 and D2(0d and 2d)
  • Liver graft primary disfunction (primary nonfunction)(10 days)
  • Liver graft primary disfunction ( Initial Poor Function)(7 days)
  • Lenght of ICU Stay(28 days)
  • Incidence of Arrythmia requiring clinical treatment(7 days)
  • Surgical site infection(28 days)

研究者

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

Rodolpho Augusto de Moura Pedro

Principal investigator

University of Sao Paulo General Hospital

研究点 (2)

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