Maternal pharmacokinetics and pharmacodynamics of nicardipine (iv) during treatment of severe hypertension in pregnancy.
- Conditions
- preeclampsia1002690810057166
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 40
Pregnant patients with preeclampsia (hypertension and protein/creatinine ratio >= 30mg/mmol or >= 300mg protein/24hours) complicated with severe hypertension (systolic bloodpressure >= 160mmHg and/or diastolic blood pressure >= 110mmHg);gestational age >= 20 weeks;working knowledge of Dutch language
Fetal indication for immediate delivery, ie. signs of fetal distress: spontaneous repeated persistent unprovoked decelerations on CTG;Fetal death or major fetal congenital anomalies or estimated fetal weight below 500 grams;Placental abruption;Concomitant medication: nifedipine, cimetidine, labetalol;Clinically relevant pulmonary edema, defined as clinically relevant respiratory failure or severe respiratory distress requiring oxygen supplementation (more than 10 litres), with rales and/or pulse oximetry of <94% on room air;Eclampsia;Suspicion of (sub)capsular liverhematoma on physical examination;Renal failure (creatinine clearance < 40 mL/min)
• Suspicion of cerebro-vascular incident on physical examination
• Suspicion of trombo-embolism on physical examination
• Other severe maternal complications
• Maternal age <16 years
• Mentally incapacitated patient
• Impossible to place an intra-arterial catheter.
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Maternal first half life (1st 24 hours after initiation), second half life<br /><br>(24hours after administration), distribution half time, elimination half time,<br /><br>assessing risk of accumulation. Changes in blood pressure, heart rate, cardiac<br /><br>output, cardiac index, stroke volume, peripheral resistance, and NT-proBNP<br /><br>values after administration of nicardipine. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Determine concentration gradient to breastmilk. Determine pharmacokinetic<br /><br>parameters in the neonate and if appropriate correlate neonatal pharmacokinetic<br /><br>parameters to neonatal pharmacodynamic changes. Exploring haemodynamic changes<br /><br>in preeclamptic patients with severe hypertension and exploring the<br /><br>haemodynamic transfer to normal in the puerperium. </p><br>