Clevidipine (Cleviprex®) Compared With Urapidil (Ebrantil®)
Schlüsselwörter
Abstrakt
Beschreibung
After admission to the ICU the patients presenting with primary intracerebral hemorrhage (ICH) are evaluated for enrollment. If systolic blood pressure (SBP) is higher than 160 mmHg or SBP <160 mmHg under intravenous antihypertensive drug (e.g. Urapidil), started less than 3 h before randomization, the patient will be randomized in one of the two study groups and intravenous therapy with Clevidipine (Cleviprex®) or Urapidil (Ebrantil®) will start immediately. Data of systemic haemodynamics will be collected continuously by online monitoring, starting at baseline and ending after 24h (study data measurements). In particular, all blood pressure measurements are extracted via an arterial line, which is placed as standard of care in these patients. If the target values are not attained within 30 minutes, the investigators can add or switch to alternative antihypertensive drugs of their choice. 24h after initiation of Clevidipine (Cleviprex®) or Urapidil (Ebrantil®), all patients receive Nicardipine (Cardene®) (standard care in daily clinical routine) for another 24h followed by orally administered antihypertensive medication.
Intracerebral hematoma volume will be determined by readings of noncontrast brain computed tomography (CT) scans using the ABC/2 rule to calculate the volume. As a standard in these patients a CT scan is performed 6 hours after admission to the ICU.
Termine
| Zuletzt überprüft: | 05/31/2020 |
| Zuerst eingereicht: | 09/07/2017 |
| Geschätzte Einschreibung eingereicht: | 10/01/2017 |
| Zuerst veröffentlicht: | 10/02/2017 |
| Letztes eingereichtes Update: | 06/06/2020 |
| Letztes Update veröffentlicht: | 06/08/2020 |
| Tatsächliches Startdatum der Studie: | 06/14/2017 |
| Geschätztes primäres Abschlussdatum: | 06/13/2021 |
| Voraussichtliches Abschlussdatum der Studie: | 09/29/2021 |
Zustand oder Krankheit
Intervention / Behandlung
Drug: Clevidipine
Drug: Urapidil
Phase
Armgruppen
| Arm | Intervention / Behandlung |
|---|---|
| Experimental: Clevidipine The treatment starts at admission to the ICU for 24 hours with 2 mg to a maximum of 16 mg Clevidipine per hour infused intravenously and continuously to reach the systolic target pressure < 160 mmHg (>120 mmHg). | Drug: Clevidipine Intravenous antihypertensive therapy with Clevidipine for the first 24 hours in patients with nontraumatic intracerebral hemorrhage (ICH). |
| Active Comparator: Urapidil The treatment starts at admission to the ICU for 24 hours with 5 mg to a maximum of 40 mg Urapidil per hour infused intravenously and continuously to reach the systolic target pressure < 160 mmHg (>120 mmHg). | Drug: Urapidil We compare the therapy with Urapidil to Clevidipine for the acute phase (24 hours) in patients with ICH. We would like to show the efficacy and safety of Clevidipine in this special situation. |
Zulassungskriterien
| Altersberechtigt für das Studium | 18 Years Zu 18 Years |
| Studienberechtigte Geschlechter | All |
| Akzeptiert gesunde Freiwillige | Ja |
| Kriterien | Inclusion Criteria: - Primary intracerebral hemorrhage (ICH) - Systolic blood pressure (SBP) > 160 mmHg at screening - Systolic blood pressure (SBP) <160 mmHg under intravenous antihypertensive drug (e.g. Urapidil), started less than 3 h before randomization - 18 to unlimited years of age - Signed informed consent obtained Exclusion Criteria: - Patients with secondary hemorrhage (bleeding source as aneurysm, arteriovenous malformation or traumatic) - Patients with concomitant severe critical illness (e.g. sepsis, multi-organ failure) - Positive pregnancy test for any female of childbearing potential or breast feeding female - Known allergy to any component of Clevidipine (Cleviprex®), Urapidil Ebrantil®), soya bean oil or severe egg protein allergy - Contraindications for Clevidipine (Cleviprex®): defect in the lipid metabolism, critical aortic stenosis - Contraindications for Urapidil (Ebrantil®): aortic coarctation, arterio-venous shunt, breastfeeding period - Patients with pre-existing disability and legal representative - Patients participating in a interventional clinical trial within the last 30 days before Start of Treatment |
Ergebnis
Primäre Ergebnismaße
1. Achieving the target systolic blood pressure [1/2 hours]
Sekundäre Ergebnismaße
1. Hypertensive burden - time [24 hours]
2. Hypotensive burden - time [24 hours]
3. Cumulative time out [24 hours]
4. Blood pressure variability [48 hours]
5. Hematoma growth [6 hours]
6. Neurological state 1 [48 hours]
7. Neurological state 2 [48 hours]
Sonstige Ergebnismaßnahmen
1. Costs [24 hours]
