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

Assiut University

Status and phase: Completed; Phase 4

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

Treatments: Drug: Glyceryl trinitrate vs phentolamine for prophylaxis against renal impairment

Study type: Interventional

Funder types: Other

Identifiers

NCT05687669

obstetric Renal prophylaxis

Details and patient eligibility

About

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.

Enrollment: 170 patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion criteria

• Severe preeclampsia defined by presentation of 2 or more of the following criteria:

  1. Blood pressure more than 160/100
  2. Proteinuria
  3. Pitting edema
  4. With or without organ dysfunctions

Exclusion criteria

1. Patient relatives' refusal
2. Recent active internal hemorrhage
3. Chronic renal impairment or failure on dialysis for any other etiology

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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170 participants in 2 patient groups

Group GTN

Experimental group

Description:

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

Treatment:

Drug: Glyceryl trinitrate vs phentolamine for prophylaxis against renal impairment

Group Phentolamine

Experimental group

Description:

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

Treatment:

Drug: Glyceryl trinitrate vs phentolamine for prophylaxis against renal impairment