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Completed

NCT Number: NCT05687669

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

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.

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Key information

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Assiut university faculty of medicine

Asyut, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Glyceryl trinitrate vs phentolamine for prophylaxis against renal impairment

Drug

Glyceryl trinitrate vs phentolamine for prophylaxis against renal impairment

Primary outcomes

  1. kidney function tests

    Time frame: 96 hours after intervention

    creatinine in micromoles per liter and urea in millimole per liter

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jan 18, 2023
Registry last updated
Dec 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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