Clinical Relevance of Nicardipine Induced Hypoxemia in the Intensive Care Unit

Hypoxemic Respiratory Failure Clinical Trial

— ECRHIN-ICU  

Official title:

Clinical Relevance of Nicardipine Induced Hypoxemia in the Intensive Care Unit. A Multicenter Prospective Observational Study Comparing Nicardipine and Urapidil

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05155202
• Other study ID #: ID2885
• Status: Active, not recruiting
• Start date: November 15, 2021
• Est. completion date: October 15, 2024

Study information

• Verified date: February 2023
• Source: University Hospital, Caen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Prospective observational study in 4 intensive care units in one general hospital and one university hospital.

Once Nicardipine or Urapidil infusion is started, data collection of respiratory related information such as type of ventilation, arterial partial pressure of oxygen, blood pressure, cardiac frequency.

Statistical analysis for two qualitative variables: Group (Nicardipine or Urapidil) and occurrence or worsening of hypoxemia. Secondary outcoumes analysed such as maximal drop of blood pressure, evolution of the PaO2/FiO2 ratio, length of hospital stay, duration of mechanical ventilation in the ventilated patients.

Analysis for different subgroups : Patients with known atelectasis, postoperative of cardiac surgery, neuro-intensive care.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 300
• Est. completion date: October 15, 2024
• Est. primary completion date: November 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Major patient

• With acute arterial systolic hypertension over 140mmHg

• Requiring intravenous administration of one of the two following drugs : Urapidil or Nicardipine

Exclusion Criteria:

• Patient ventilated Under Nitrogen Monoxyde

• Contraindication to Nicardipine or Urapidil

• Refusal of the patient or his relatives

• Patient treated for pulmonary hypertension

Related Conditions & MeSH terms

• Emergencies
• Hypertensive Emergency
• Hypoxemic Respiratory Failure
• Hypoxia
• Respiratory Insufficiency
• Side Effect

Intervention

Drug:
• Antihypertensive Agents
Administration of intravenous Nicardipine or Urapidil

Locations

Country	Name	City	State
France	CHU CAEN	Caen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hypoxemia	Occurrence of worsening of hypoxemia	During the twelve hours following start of drug infusion
Secondary	Efficacy of antihypertensive action	Time before the drop of arterial systolic blood pressure below 140mmHg	During the twelve hours following start of drug infusion