Treatment of Severe Hypertension During Pre-Eclampsia: A Preliminary Equivalence Study Between Urapidil and Nicardipine
NCT ID: NCT00409253
Last Updated: 2009-02-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
72 participants
INTERVENTIONAL
2007-06-30
2010-08-31
Brief Summary
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* efficacy endpoint : mean arterial blood pressure corrected to 105-125 mmHg after 120 min of study drug administration.
* safety endpoints : clinical, biological and ultrasound observation for any side effect.All infants will be observed in the neonatology unit (during 48h).
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Urapidil
URAPIDIL (EUPRESSYL*)
Urapidil (Eupressyl\*) :IV (PSE) 1 microg/kg/min° until reduction PAM 15 %. Reduction ¼ of the posology to obtain PAM between 105 and 125 mmHg with adjustment 0.25 microg/kg/min/15 min. Maximal dose = 30mg/h.
Nicardipine
NICARDIPINE
Nicardipine : IV 6.25 mg bolus until PAD \>105 mm/Hg. Perfusion (PSE) 4 mg/h to obtain PAM between 105 and 125 mm/Hg with adjustment 2mg/h/5 min without overshoot 20 mg/h Maximal treatment duration : 7 days
Interventions
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URAPIDIL (EUPRESSYL*)
Urapidil (Eupressyl\*) :IV (PSE) 1 microg/kg/min° until reduction PAM 15 %. Reduction ¼ of the posology to obtain PAM between 105 and 125 mmHg with adjustment 0.25 microg/kg/min/15 min. Maximal dose = 30mg/h.
NICARDIPINE
Nicardipine : IV 6.25 mg bolus until PAD \>105 mm/Hg. Perfusion (PSE) 4 mg/h to obtain PAM between 105 and 125 mm/Hg with adjustment 2mg/h/5 min without overshoot 20 mg/h Maximal treatment duration : 7 days
Eligibility Criteria
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Inclusion Criteria
* affiliation to a social security system
* single pregnancy
* arterial hypertension (PAS ≥140 and/or PAD≥90) in the context of severe pre-eclampsia
Exclusion Criteria
* protocol rejected by patient-impossibility to use non invasive blood pressure monitoring
* antihypertensive treatments within 24h before inclusion
* allergy to or contraindication for one of the study drugs-pre
* eclampsia that does not require an antihypertensive treatment
* acute eclampsia-requirement for other drugs with potential dangerous interactions with study drugs
* participation to a therapeutic protocol within 6 months prior to the start of study
18 Years
51 Years
FEMALE
No
Sponsors
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University Hospital, Strasbourg, France
OTHER
Responsible Party
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Direction de la Recherche Clinique et de l'Innovation - Hôpitaux Universitaires de Strasbourg
Principal Investigators
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Pierre Auguste DIEMUNSCH, MD
Role: PRINCIPAL_INVESTIGATOR
Hôpitaux Universitaires de Strasbourg
Locations
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Hôpital Saint-Jacques, CHU de Besançon
Besançon, , France
Maternité A. PINARD
Nancy, , France
Sihcus-Cmco
Schiltigheim, , France
Service d'Anesthésie et de Réanimation Médicale, Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg
Strasbourg, , France
Countries
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Central Contacts
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Facility Contacts
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References
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Diemunsch P, Garcia V, Lyons G, Pottecher J, Emmanuel S. Urapidil versus nicardipine in preeclamptic toxaemia: A randomised feasibility study. Eur J Anaesthesiol. 2015 Nov;32(11):822-3. doi: 10.1097/EJA.0000000000000303. No abstract available.
Other Identifiers
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3738
Identifier Type: -
Identifier Source: org_study_id
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