Clinical Relevance of Nicardipine Induced Hypoxemia in the Intensive Care Unit (ECRHIN-ICU)

February 12, 2024 updated by: University Hospital, Caen

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Actual)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Caen, France
        • CHU caen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All hypertensive patients in the intensive care unit

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hypoxemia
Time Frame: During the twelve hours following start of drug infusion
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 Frame: During the twelve hours following start of drug infusion
Time before the drop of arterial systolic blood pressure below 140mmHg
During the twelve hours following start of drug infusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Caen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 15, 2021

Primary Completion (Actual)

November 15, 2023

Study Completion (Estimated)

October 15, 2024

Study Registration Dates

First Submitted

December 1, 2021

First Submitted That Met QC Criteria

December 1, 2021

First Posted (Actual)

December 13, 2021

Study Record Updates

Last Update Posted (Actual)

February 13, 2024

Last Update Submitted That Met QC Criteria

February 12, 2024

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ID2885

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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