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临床试验/NCT05687669
NCT05687669已完成4 期

Comparison Between the Use of Phentolamine Versus Glyceryl Trinitrate for Their Effect on Renal Function in Pre-eclampsia Patients in ICU

Assiut University1 个研究点 分布在 1 个国家目标入组 170 人开始时间: 2023年1月12日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
170
试验地点
1
主要终点
kidney function tests

研究概览

简要总结

Severe pre-eclamptic toxemia has a high incidence of renal complications. Rapid diagnosis and termination of pregnancy are still the gold standard main treatment for pre-eclampsia. Rapid control of blood pressure showed to provide protection against many adverse effects of preeclampsia as intracranial hemorrhage, subcapsular hepatic hematoma and acute kidney injury (AKI).

In Assiut university hospital ICU regimen, glyceryl trinitrate (GTN) was used primarily for this purpose. But it was accused in many cases as a cause for AKI without any other organ damage along with the severe preeclampsia disease. Some previous studies supported this assumption as , Ying-Hsuan .T. et.,al during their study of GTN on renal outcome during cardiopulmonary bypass in cardiac surgery. Phentolamine infusion is a new rising alternative for an old drug with a high safety profile.

In this research protocol the researchers will study comparative effect of glyceryl trinitrate (GTN) versus phentolamine on renal outcome in severe pre-eclampsia patients during their stay in obstetric ICU.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

盲法说明

Group(A): Glyceryl trinitrate (GTN) is labelled with "Drug A" on syringe pump. Group(B): Phentolamine is labelled with "Drug B" on syringe pump.

入排标准

性别
Female
接受健康志愿者

入选标准

  • Severe preeclampsia defined by presentation of 2 or more of the following criteria:
  • Blood pressure more than 160/100
  • Proteinuria
  • Pitting edema
  • With or without organ dysfunctions

排除标准

  • Patient relatives' refusal
  • Recent active internal hemorrhage
  • Chronic renal impairment or failure on dialysis for any other etiology

研究组 & 干预措施

Group GTN

Experimental

Glyceryl trinitrates (GTN) is infused to patients with severe hypertensive preeclampsia till oral anti-hypertensives and Magnesium sulfate loadings lower blood pressure

干预措施: Glyceryl trinitrate vs phentolamine for prophylaxis against renal impairment (Drug)

Group Phentolamine

Experimental

Phentolamine is infused to patients with severe hypertensive preeclampsia till oral anti-hypertensives and Magnesium sulfate loadings lower blood pressure

干预措施: Glyceryl trinitrate vs phentolamine for prophylaxis against renal impairment (Drug)

结局指标

主要结局

kidney function tests

时间窗: 96 hours after intervention

creatinine in micromoles per liter and urea in millimole per liter

次要结局

未报告次要终点

研究者

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

Ayman Abd El-Khalek Mohammed Glala

Lecturer

Assiut University

研究点 (1)

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