Comparison Between the Use of Phentolamine Versus Glyceryl Trinitrate for Their Effect on Renal Function in Pre-eclampsia Patients in ICU
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
- 否
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
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
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
Ayman Abd El-Khalek Mohammed Glala
Lecturer
Assiut University
