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

Primary Purpose

Pre-Eclampsia; Complicating Pregnancy, Pre-eclampsia Aggravated

Status

Not yet recruiting

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

Glyceryl trinitrate vs phentolamine for prophylaxis against renal impairment

About this trial

This is an interventional prevention trial for Pre-Eclampsia; Complicating Pregnancy

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Group GTN

Group Phentolamine

Arm Description

Glyceryl trinitrates (GTN) is infused to patients with severe hypertensive preeclampsia till oral anti-hypertensives and Magnesium sulfate loadings lower blood pressure

Phentolamine is infused to patients with severe hypertensive preeclampsia till oral anti-hypertensives and Magnesium sulfate loadings lower blood pressure

Outcomes

Primary Outcome Measures

kidney function tests

creatinine in micromoles per liter and urea in millimole per liter

Secondary Outcome Measures

Full Information

NCT ID

NCT05687669

First Posted

December 7, 2022

Last Updated

January 7, 2023

Sponsor

Assiut University

1. Study Identification

Unique Protocol Identification Number

NCT05687669

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

January 12, 2023 (Anticipated)

Primary Completion Date

April 12, 2023 (Anticipated)

Study Completion Date

June 12, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Assiut University

4. Oversight

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.

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pre-Eclampsia; Complicating Pregnancy, Pre-eclampsia Aggravated

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

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:

Masking

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.

Allocation

Randomized

Enrollment

170 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Group GTN

Arm Type

Experimental

Arm Description

Glyceryl trinitrates (GTN) is infused to patients with severe hypertensive preeclampsia till oral anti-hypertensives and Magnesium sulfate loadings lower blood pressure

Arm Title

Group Phentolamine

Arm Type

Experimental

Arm Description

Phentolamine is infused to patients with severe hypertensive preeclampsia till oral anti-hypertensives and Magnesium sulfate loadings lower blood pressure

Intervention Type

Drug

Intervention Name(s)

Glyceryl trinitrate vs phentolamine for prophylaxis against renal impairment

Intervention Description

Glyceryl trinitrate vs phentolamine for prophylaxis against renal impairment

Primary Outcome Measure Information:

Title

kidney function tests

Description

creatinine in micromoles per liter and urea in millimole per liter

Time Frame

96 hours after intervention

10. Eligibility

Sex

Female

Gender Based

Yes

Gender Eligibility Description

only in preeclampsia patients which is complicating pregnancy in females

Accepts Healthy Volunteers

Eligibility Criteria

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

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

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