ECRHIN-ICU: Clinical Relevance of Nicardipine Induced Hypoxemia in the Intensive Care Unit
Study Details
Study Description
Brief Summary
In the context of postoperative hypertension in the intensive care units, or after rescusitation of hypertensive patients, intravenous antihypertensive drugs are often used. Among thoses druges, 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
Prospective observational study in 8 intensive care units in three general hospitals 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 (Nicardipin 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Nicardipine Major patients hospitalized in intensive care unit, with systolic hypertension, requiring administration of intravenous Nicardipine. |
Drug: Antihypertensive Agents
Administration of intravenous Nicardipine or Urapidil
|
| Urapidil Major patients hospitalized in intensive care unit, with systolic hypertension, requiring administration of intravenous Urapidil. |
Drug: Antihypertensive Agents
Administration of intravenous Nicardipine or Urapidil
|
Outcome Measures
Primary Outcome Measures
- Hypoxemia [During the twelve hours following start of drug infusion]
Occurrence of worsening of hypoxemia
Secondary Outcome Measures
- Efficacy of antihypertensive action [During the twelve hours following start of drug infusion]
Time before the drop of arterial systolic blood pressure below 140mmHg
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | CHU CAEN | Caen | France |
Sponsors and Collaborators
- University Hospital, Caen
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ID2885