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

Sponsor

Assiut University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05687669

Collaborator

(none)

170

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pre-Eclampsia; Complicating Pregnancy Pre-eclampsia Aggravated	Drug: Glyceryl trinitrate vs phentolamine for prophylaxis against renal impairment	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

170 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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: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:

Masking:

Single (Participant)

Masking Description:

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

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Jan 12, 2023

Anticipated Primary Completion Date :

Apr 12, 2023

Anticipated Study Completion Date :

Jun 12, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group GTN 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 Glyceryl trinitrate vs phentolamine for prophylaxis against renal impairment
Experimental: Group Phentolamine 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 Glyceryl trinitrate vs phentolamine for prophylaxis against renal impairment

Arm

Intervention/Treatment

Experimental: Group GTN

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

Glyceryl trinitrate vs phentolamine for prophylaxis against renal impairment

Experimental: Group Phentolamine

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

Glyceryl trinitrate vs phentolamine for prophylaxis against renal impairment

Outcome Measures

Primary Outcome Measures

kidney function tests [96 hours after intervention]
creatinine in micromoles per liter and urea in millimole per liter

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ayman Abd El-Khalek Mohammed Glala, Lecturer, Assiut University

ClinicalTrials.gov Identifier:

NCT05687669

Other Study ID Numbers:

obstetric Renal prophylaxis

First Posted:

Jan 18, 2023

Last Update Posted:

Jan 18, 2023

Last Verified:

Jan 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Eclampsia

Pre-Eclampsia

Pregnancy Complications

Phentolamine

Nitroglycerin

Study Results

No Results Posted as of Jan 18, 2023