Trial intelligence / Profile preview

Norepinephrine Boluses for Prevention of Postreperfusion Syndrome in LDLT

NCT03773276Phase 2

Key facts

Status
Completed
Start
Dec 2018
Primary completion
Apr 2020
Countries
1
Sponsor
Mansoura University
Modality
Small Molecules
Conditions
Post-reperfusion syndrome (PRS)
01

Overview

Phase 2, open-label, single-arm trial of norepinephrine in Post-reperfusion syndrome (PRS), sponsored by Mansoura University. Primary endpoint: Incidence of postreperfusion syndrome. Started Dec 2018; status: completed.

02

Design

1 arm
Study design
Non-randomizedOpen-label
  • Norepinephrine boluses

    Patients receive Norepinephrine boluses during portal vein declamping to maintain mABP

03

Who it enrols

Patients undergoing living donor liver transplantation with right lobe graft. Excludes acute fulminant hepatitis, chronic hypertension, moderate/severe valvular heart disease, CKD, hepatorenal syndrome, preoperative serum creatinine > 1.4 mg/dL (text says mg/kg, likely typo), long-standing diabetes (>10 years on insulin), moderate/severe porto-pulmonary hypertension or hepatopulmonary syndrome, Budd Chiari syndrome, re-transplantation, massive blood transfusion, and graft/weight ratio > 1.4 or < 0.8.

04

Endpoints

Primary

  • Incidence of postreperfusion syndrome

Secondary

  • Arrhythmia

  • Ischemia

  • Liver graft function

  • Acute kidney injury

  • 3-month survival

  • one-year survival

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