Clinical Relevance of Nicardipine Induced Hypoxemia in the Intensive Care Unit

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Hypoxemic Respiratory Failure, Side Effect, Hypertensive Emergency

Intervention / Treatment
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* Drug: Antihypertensive Agents


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Nicardipine<br>Major patients hospitalized in intensive care unit, with systolic hypertension, requiring administration of intravenous Nicardipine. | Drug: Antihypertensive Agents<br>* Administration of intravenous Nicardipine or Urapidil<br>|
| Urapidil<br>Major patients hospitalized in intensive care unit, with systolic hypertension, requiring administration of intravenous Urapidil. | Drug: Antihypertensive Agents<br>* Administration of intravenous Nicardipine or Urapidil<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hypoxemia | Occurrence of worsening of hypoxemia | During the twelve hours following start of drug infusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of antihypertensive action | Time before the drop of arterial systolic blood pressure below 140mmHg | During the twelve hours following start of drug infusion |