The Treatment of Hypertension Associated With Severe Preeclampsia (PE). A Trial of Urapidil Versus Nicardipine

NCT ID: NCT02558023

Last Updated: 2020-08-25

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2020-08-31

Brief Summary

The objective of this study is to demonstrate that urapidil is not inferior to nicardipine for the treatment of hypertension associated with preeclampsia (PE) and that it is better tolerated.

• efficacy endpoint : mean arterial blood pressure corrected to 100-120 mmHg after 120 min of study drug administration.
• safety endpoints : clinical and biological observation for any side effect. All infants will be observed in the neonatology unit (during 48h).

Pharmacokinetic study included to study :

• transplacental transfer,
• transfer in breast milk,
• and neonatal elimination (premature babies of mothers treated with urapidil (less than 33 WG))

Conditions

Hypertension; Preeclampsia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Urapidil

Urapidil (Eupressyl*) : IV One initial iv bolus of 12.5 mg. One or more bolus of 6.25 mg at intervals of 5 minutes if the diastolic pressure remains above 100 mmHg.

The treatment is then continued at 4 mg.h-1 iv via a syringe pump. The maintenance dose needed to maintain MAP between 100 and 120 mmHg is sought by adjustments of ± 2 mg.h-1every 5 minutes.

Maximum dose of 30 mg.h-1.

Group Type: EXPERIMENTAL

Urapidil

Intervention Type: DRUG

Urapidil (Eupressyl*) : IV One initial iv bolus of 12.5 mg. One or more bolus of 6.25 mg at intervals of 5 minutes if the diastolic pressure remains above 100 mmHg.

The treatment is then continued at 4 mg.h-1 iv via a syringe pump. The maintenance dose needed to maintain MAP between 100 and 120 mmHg is sought by adjustments of ± 2 mg.h-1every 5 minutes.

Maximum dose of 30 mg.h-1.

Nicardipine

Nicardipine : IV

1 mcg.kg-1.min-1until reduction MAP 15%. Reduction 1/4 of the posology (0.75 mcg.kg -1.min-1). The maintenance dose needed to maintain MAP between 100 and 120 mmHg is then sought by adjustments of ± 0.25 mcg.kg.min-1every 5 minutes.

Maximum dose of 6 mg.h-1

Group Type: ACTIVE_COMPARATOR

Nicardipine

Intervention Type: DRUG

Nicardipine : IV

1 mcg.kg-1.min-1until reduction MAP 15%. Reduction 1/4 of the posology (0.75 mcg.kg -1.min-1). The maintenance dose needed to maintain MAP between 100 and 120 mmHg is then sought by adjustments of ± 0.25 mcg.kg.min-1every 5 minutes.

Maximum dose of 6 mg.h-1

Interventions

Urapidil

Urapidil (Eupressyl*) : IV One initial iv bolus of 12.5 mg. One or more bolus of 6.25 mg at intervals of 5 minutes if the diastolic pressure remains above 100 mmHg.

The treatment is then continued at 4 mg.h-1 iv via a syringe pump. The maintenance dose needed to maintain MAP between 100 and 120 mmHg is sought by adjustments of ± 2 mg.h-1every 5 minutes.

Maximum dose of 30 mg.h-1.

Intervention Type: DRUG

Nicardipine

Nicardipine : IV

1 mcg.kg-1.min-1until reduction MAP 15%. Reduction 1/4 of the posology (0.75 mcg.kg -1.min-1). The maintenance dose needed to maintain MAP between 100 and 120 mmHg is then sought by adjustments of ± 0.25 mcg.kg.min-1every 5 minutes.

Maximum dose of 6 mg.h-1

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Adult patients
• Singleton pregnancy
• Patients with remaining hypertension despite an oral treatment for who an iv antihypertensive treatment is indicated

Patient with PE, as defined by :

• Systolic Blood Pressure (BP) ≥ 140 mmHg and/or Diastolic BP ≥ 90 mmHg, after the 20th week of amenorrhea, without chronic hypertension, AND
• Proteinuria > 300 mg.day-1 or > 2 crosses(++) on an urinary dipstick,

OR

Patient with severe Pregnancy Induced Hypertension (PIH), as defined by :

Systolic BP ≥ 160 mmHg and/or Diastolic BP ≥110 mmHg, after the 20th week of amenorrhea, without chronic hypertension,

• Written informed consent signed and dated by both investigator and patient,
• Valid social security affiliation

Exclusion Criteria

• Known allergy to study drugs
• Contra-indication to the study drugs: stenosis of the aortic isthmus, arteriovenous shunt, coarctation of the aorta, unstable angina, compensatory hypertension, myocardial infarction < 8 days.
• Eclampsia
• Person with difficulty understanding information
• Person with diminished responsibility,
• Ongoing intravenous antihypertensive treatment,
• No pressure cuff adapted to the morphology of the arms of the patients
• Concomitant use of 5 phosphodiesterase inhibitors
• Participation in a clinical trial within 6 months prior to inclusion

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Strasbourg, France

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pierre DIEMUNSCH, PUPH

Role: PRINCIPAL_INVESTIGATOR

Hôpitaux Universitaires de Strasbourg

Locations

Service d'Anesthésie - CMCO

Schiltigheim, , France

Service d'Anesthésie et de Réanimation Médicale, Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg

Strasbourg, , France

Countries

France

Other Identifiers

5866

Identifier Type: -

Identifier Source: org_study_id