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临床试验/NCT04594629
NCT04594629Unknown1 期

Efficacy of Nebulized PGI2 Versus Nebulized Nitroglycerine for Management of Pulmonary Hypertension After Valve Replacement Surgeries

Ain Shams University1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2020年11月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
入组人数
120
试验地点
1
主要终点
mean pulmonary artery pressure

研究概览

简要总结

This study was conducted in 120 patients aged from 54-65 years scheduled for elective valve replacement surgeries. Patients were randomly allocated to nitro glycerine or PGI2 groups. Patients of nitro glycerine group received nebulized nitro glycerine at a rate of 2.5-5 mcg/kg/min (5 mg, 1 mg/ml) over 10 minutes by ultrasonic nebuliser. Patients of PGI2 group received nebulized PGI2 (epoprostenol), 20000 ng/ml (20000 ng/ml in 60 ml syringe was attached to an intravenous pump which delivers a titrating rate of 8 ml/h . The primary outcome was mean pulmonary artery pressure. The secondary outcomes included mean arterial blood pressure (MAP) (mmHg), PaO2/FiO2 ratio, cardiac index (CI) (l/min/m2) right ventricular ejection fraction (RVEF), central venous pressure(CVP) , 30-day mortality rate and the incidence of complications such as facial flushing, hypotension and re-exploration for bleeding.

详细描述

Postoperative pulmonary hypertension (PHT) is the most challenging complication of valvular heart disease about 73% of the patients particularly in those posted for mitral valve replacement surgery Methods This prospective study was conducted in 120 patients aged from 54-65 years scheduled for elective valve replacement surgeries. Patients were randomly allocated to either nitro glycerine or PGI2 groups. Patients of nitro glycerine group received nebulized nitro glycerine (its starting concentration was 200 mcg/ml); nitro glycerine was delivered at a rate of 2.5-5 mcg/kg/min (5 mg, 1 mg/ml) over 10 minutes by ultrasonic nebuliser connected to the inspiratory limb of the breathing circuit. Patients of PGI2 group received nebulized PGI2 (epoprostenol), 20000 ng/ml (20000 ng/ml in 60 ml syringe was attached to an intravenous pump which delivers a titrating rate of 8 ml/h to the nebulizer compartment. The primary outcome was mean pulmonary artery pressure. The secondary outcomes included mean arterial blood pressure (MAP) (mmHg), PaO2/FiO2 ratio, cardiac index (CI) (l/min/m2) right ventricular ejection fraction (RVEF), central venous pressure(CVP) measured at the end of cardiopulmonary bypass then 30 minutes after start of treatment then 4 hours after start of treatment, 30-day mortality rate and the incidence of complications such as facial flushing, hypotension and re-exploration for bleeding.

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
54 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 35 to 66 years old
  • elective valve replacement surgery
  • pulmonary arterial hypertension

排除标准

  • Emergency surgery
  • severe renal and hepatic dysfunction
  • uncontrolled supraventricular arrhythmia
  • those requiring preoperative inotropes

研究组 & 干预措施

nitroglycerine group

Sham Comparator

Patients of nitroglycerine group received nebulized nitro glycerine (a vial contains 50 mg nitroclycerine ), its starting concentration was 200 mcg/ml with nitro glycerine was delivered at 2.5-5 mcg/kg/min (5 mg, 1 mg/ml) over 10 minutes by ultrasonic nebuliser connected to the inspiratory limb of the breathing circuit

干预措施: Nitroglycerin (Drug)

PGI2 group

Active Comparator

Patients of PGI2 group received nebulized PGI2 (epoprostenol), 20000 ng/ml (Flolan; Glaxo Wellcome Inc, Research Triangle Park, NC) (60 ml syringe of PGI2 with concentration 20000 ng/ml was attached to an intravenous pump which delivers a titrating rate of 8 ml/h to the nebulizer compartment (MiniHEART nebulizer; Westmed, Tucson, Ariz) fixed to the inspiratory limb of the breathing circuit or to the face mask with venturi accessory for sprinkling. The nebulizer was filled with 15 ml PGI2 with nebulized oxygen flow rate 3 litres.

干预措施: PGI2 (Drug)

结局指标

主要结局

mean pulmonary artery pressure

时间窗: baseline, 30 minutes after start of study drug, 4 hours after start of study drug

decrease of mean pulmonary artery pressure

次要结局

  • mortality(30 days postoperative)
  • central venous pressure(at the end of cardiopulmonary bypass (baseline values) then 30 minutes after start of treatment then 4 hours after start of treatment)

研究者

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

Hoda Shokri

Assistant professor of Anaesthesiology

Ain Shams University

研究点 (1)

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