Clevidipine in Neurocritical Patients

NCT05168059 | Completed DMC

• 1 other identifier: CEIC E19/17
• Study Type: observational
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

Acute blood pressure elevation is a frequent problem in neurocritical patients. Its effective management is challenging and must avoid significant decreases of blood pressure leading to lower cerebral perfusion pressure worsening ischemia and elevations probably associated with bleeding, rebleeding or hematoma expansion associated with poor prognosis

Conditions

High Blood Pressure

Keywords

clevidipine; neurocritical

Outcome Measures

Primary Outcomes (1)

• Effectiveness of clevidipine

  Percentage of patients achieving target systolic blood pressure (SBP)

  1 to 6 hour of clevidipine infusion beginning

Secondary Outcomes (1)

• Incidence of adverse events related to clevidipine treatment

  1 hour after beginning to 24 hours after clevidipine infusion stop

Other Outcomes (12)

• Effectiveness of clevidipine treatment according sex

  1 to 6 hours after clevidipine infusion beginning

• Effectivennes of clevidipine treatment according medical history

  1 to 6 hours after clevidipine infusion beginning

• Effectivennes of clevidipine treatment according neurosurgical procedure

  1 to 6 hours after clevidipine infusion beginning

Interventions

Clevidipine 0.5 MG/ML Intravenous Emulsion DRUG

Effectiveness and safety of clevidipine

Also known as: CLEVIPREX

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Neurocritical patients admitted to PostOperative Intensive Care Unit after acute intracerebral hemorrhage requiring surgical treatment, mechanical thrombectomy for acute ischemic stroke, embolization of aneurysm causing subarachnoid hemorrhage and scheduled neurosurgical and neuroradiology procedures.

You may qualify if:

• Adult patients older than 18 years old admitted to Post-Operative Intensive Care Unit with neurocritical condition requiring surgical or interventional treatment.
• Acute High Blood Pressure requiring urgent treatment (SBP ≥160 mmHg or ≥ 20% increase in preoperative values that persists for more than 15 minutes)
• Clevidipine used as a first line or after failure of different antihypertensive drugs.

You may not qualify if:

• Adults older than 90 years admitted to Post-Operative Intensive Care Unit with neurocritical condition requiring surgical or interventional treatment.
• Patients admitted to Post-Operative Intensive Care Unit with neurocritical condition not requiring surgical or interventional treatment.

Sponsors & Collaborators

• Hospital de Cruces: lead
• Biobizkaia Health Research Institute: collaborator

Study Sites (1)

Biocruces

Barakaldo, Vizcaya, 48903, Spain

Location

MeSH Terms

Conditions

Hypertension

Interventions

clevidipine

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Blanca Escontrela, Consultant

  Biobizkaia Health Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Anesthesiology and Reanimation

Study Record Dates

• First Submitted: November 18, 2021
• First Posted: December 23, 2021
• Study Start: January 1, 2017
• Primary Completion: December 31, 2018
• Study Completion: September 1, 2019
• Last Updated: December 23, 2021

Record last verified: 2021-12

Locations

ES (1)