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

NCT05687669 | Completed Phase 4

• 1 other identifier: obstetric Renal prophylaxis
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pre-Eclampsia; Complicating Pregnancy; Pre-eclampsia Aggravated

Outcome Measures

Primary Outcomes (1)

• kidney function tests

  creatinine in micromoles per liter and urea in millimole per liter

  96 hours after intervention

Study Arms (2)

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

Drug: Glyceryl trinitrate vs phentolamine for prophylaxis against renal impairment

Group Phentolamine

EXPERIMENTAL

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

Interventions

Glyceryl trinitrate vs phentolamine for prophylaxis against renal impairment DRUG

Glyceryl trinitrate vs phentolamine for prophylaxis against renal impairment

Group GTN; Group Phentolamine

Eligibility Criteria

• Gender Eligibility Details: only in preeclampsia patients which is complicating pregnancy in females
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut university faculty of medicine

Asyut, Egypt

Location

MeSH Terms

Conditions

Pre-Eclampsia; Pregnancy Complications

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Group(A): Glyceryl trinitrate (GTN) is labelled with "Drug A" on syringe pump. Group(B): Phentolamine is labelled with "Drug B" on syringe pump.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Model Details: 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:

Study Record Dates

• First Submitted: December 7, 2022
• First Posted: January 18, 2023
• Study Start: January 12, 2023
• Primary Completion: April 12, 2023
• Study Completion: June 12, 2023
• Last Updated: December 26, 2025

Record last verified: 2025-12

Locations

EG (1)