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

Study Overview
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Brief Summary
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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.

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

Conditions
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Pre-Eclampsia; Complicating Pregnancy, Pre-eclampsia Aggravated

Intervention / Treatment
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* Drug: Glyceryl trinitrate vs phentolamine for prophylaxis against renal impairment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Patient relatives' refusal Recent active internal hemorrhage Chronic renal impairment or failure on dialysis for any other etiology
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective study will be done in Assiut university hospital obstetric ICU, 2 groups will be examined and randomly assigned: group A using glyceryl trinitrate (GTN) to emergency control of blood pressure and group B using phentolamine infusion to control blood pressure. Each group consists of 85patients:
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group GTN<br>Glyceryl trinitrates (GTN) is infused to patients with severe hypertensive preeclampsia till oral anti-hypertensives and Magnesium sulfate loadings lower blood pressure | Drug: Glyceryl trinitrate vs phentolamine for prophylaxis against renal impairment<br>* Glyceryl trinitrate vs phentolamine for prophylaxis against renal impairment<br>|
| Experimental: Group Phentolamine<br>Phentolamine is infused to patients with severe hypertensive preeclampsia till oral anti-hypertensives and Magnesium sulfate loadings lower blood pressure | Drug: Glyceryl trinitrate vs phentolamine for prophylaxis against renal impairment<br>* Glyceryl trinitrate vs phentolamine for prophylaxis against renal impairment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| kidney function tests | creatinine in micromoles per liter and urea in millimole per liter | 96 hours after intervention |