Pre-eclampsia Aggravated, Pre-Eclampsia; Complicating Pregnancy
Conditions
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.
Interventions
DRUGGlyceryl trinitrate vs phentolamine for prophylaxis against renal impairment
Glyceryl trinitrate vs phentolamine for prophylaxis against renal impairment
Sponsors
Assiut University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
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.
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:
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| kidney function tests | 96 hours after intervention | creatinine in micromoles per liter and urea in millimole per liter |
Countries
Egypt
Outcome results
None listed