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

Phase 4

Not yet recruiting

• Conditions: Pre-Eclampsia; Complicating Pregnancy; Pre-eclampsia Aggravated
• Interventions: Drug: Glyceryl trinitrate vs phentolamine for prophylaxis against renal impairment

• Registration Number: NCT05687669
• Lead Sponsor: Assiut University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-12-07
• Status Verified: 2023-01
• Study First Submitted QC: 2023-01-07
• Last Update Submitted: 2023-01-07
• Study Start: 2023-01-12
• Study First Posted: 2023-01-18
• Last Update Posted: 2023-01-18
• Primary Completion: 2023-04-12
• Study Completion: 2023-06-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 170

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group GTN	Glyceryl trinitrate vs phentolamine for prophylaxis against renal impairment	Glyceryl trinitrates (GTN) is infused to patients with severe hypertensive preeclampsia till oral anti-hypertensives and Magnesium sulfate loadings lower blood pressure
Group Phentolamine	Glyceryl trinitrate vs phentolamine for prophylaxis against renal impairment	Phentolamine is infused to patients with severe hypertensive preeclampsia till oral anti-hypertensives and Magnesium sulfate loadings lower blood pressure

Primary Outcome Measures

Name	Time	Method
kidney function tests	96 hours after intervention	creatinine in micromoles per liter and urea in millimole per liter