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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

NCT ID: NCT05687669

Last Updated: 2025-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

170 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-12

Study Completion Date

2023-06-12

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.

Detailed Description

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Conditions

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Pre-Eclampsia; Complicating Pregnancy Pre-eclampsia Aggravated

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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:
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

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

Study Groups

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Group GTN

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

Group Type EXPERIMENTAL

Glyceryl trinitrate vs phentolamine for prophylaxis against renal impairment

Intervention Type DRUG

Glyceryl trinitrate vs phentolamine for prophylaxis against renal impairment

Group Phentolamine

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

Group Type EXPERIMENTAL

Glyceryl trinitrate vs phentolamine for prophylaxis against renal impairment

Intervention Type DRUG

Glyceryl trinitrate vs phentolamine for prophylaxis against renal impairment

Interventions

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Glyceryl trinitrate vs phentolamine for prophylaxis against renal impairment

Glyceryl trinitrate vs phentolamine for prophylaxis against renal impairment

Intervention Type DRUG

Eligibility Criteria

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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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Ayman Abd El-Khalek Mohammed Glala

Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Assiut university faculty of medicine

Asyut, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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obstetric Renal prophylaxis

Identifier Type: -

Identifier Source: org_study_id