Clinical Relevance of Nicardipine Induced Hypoxemia in the Intensive Care Unit

NCT05155202 | Unknown

• 1 other identifier: ID2885
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

In the context of postoperative hypertension in the intensive care units, or after resusitation of hypertensive patients, intravenous antihypertensive drugs are often used. Among those drugs, Nicardipine is an effective drug, but with side effects such as inhibition of pulmonary vasoconstriction. Only preclinical studies have investigated the pathophysiology of this mechanism, and no clinical study have proven its clinical relevance. The aim of this study is to establish the incidence of Nicardipine induced hypoxemia and to compare it to another antihypertensive agent, Urapidil.

Conditions

Hypoxemic Respiratory Failure; Side Effect; Hypertensive Emergency

Outcome Measures

Primary Outcomes (1)

• Hypoxemia

  Occurrence of worsening of hypoxemia

  During the twelve hours following start of drug infusion

Secondary Outcomes (1)

• Efficacy of antihypertensive action

  During the twelve hours following start of drug infusion

Study Arms (2)

Nicardipine

Major patients hospitalized in intensive care unit, with systolic hypertension, requiring administration of intravenous Nicardipine.

Drug: Antihypertensive Agents

Urapidil

Major patients hospitalized in intensive care unit, with systolic hypertension, requiring administration of intravenous Urapidil.

Drug: Antihypertensive Agents

Interventions

Antihypertensive Agents DRUG

Administration of intravenous Nicardipine or Urapidil

Nicardipine; Urapidil

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All hypertensive patients in the intensive care unit

You may qualify if:

• Major patient
• With acute arterial systolic hypertension over 140mmHg
• Requiring intravenous administration of one of the two following drugs : Urapidil or Nicardipine

You may not qualify if:

• Patient ventilated Under Nitrogen Monoxyde
• Contraindication to Nicardipine or Urapidil
• Refusal of the patient or his relatives
• Patient treated for pulmonary hypertension

Sponsors & Collaborators

• University Hospital, Caen: lead

Study Sites (1)

CHU CAEN

Caen, France

Location

MeSH Terms

Conditions

Respiratory Insufficiency; Hypertensive Crisis

Interventions

Antihypertensive Agents

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Cardiovascular Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2021
• First Posted: December 13, 2021
• Study Start: November 15, 2021
• Primary Completion: November 15, 2023
• Study Completion: October 15, 2024
• Last Updated: February 13, 2024

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)