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

Pre-Eclampsia; Complicating Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05687669
• Other study ID #: obstetric Renal prophylaxis
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: January 12, 2023
• Est. completion date: June 12, 2023

Study information

• Verified date: January 2023
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 170
• Est. completion date: June 12, 2023
• Est. primary completion date: April 12, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Eclampsia
• Pre-Eclampsia
• Pre-eclampsia Aggravated
• Pre-Eclampsia; Complicating Pregnancy
• Pregnancy Complications

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	kidney function tests	creatinine in micromoles per liter and urea in millimole per liter	96 hours after intervention