Hypoxemic Respiratory FailureECRHIN-ICUNCT05155202
Clinical Relevance of Nicardipine Induced Hypoxemia in the Intensive Care Unit
An observational study of Hypoxemic Respiratory Failure and Side Effect, run by University Hospital, Caen at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypoxemic Respiratory Failure, Side Effect, Hypertensive Emergency
- What is being tested?
- Antihypertensive Agents
- Type of treatment
- Injection or infusion
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- 15 Nov 2021to 15 Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All hypertensive patients in the intensive care unit
Who may be able to join
- Major patient
- With acute arterial systolic hypertension over 140mmHg
- Requiring intravenous administration of one of the two following drugs : Urapidil or Nicardipine
Who cannot join
- Patient ventilated Under Nitrogen Monoxyde
- Contraindication to Nicardipine or Urapidil
- Refusal of the patient or his relatives
- Patient treated for pulmonary hypertension
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Antihypertensive Agents
- Medical subject headings
- Respiratory Insufficiency, Hypertensive Crisis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antihypertensive AgentsDrug
Administration of intravenous Nicardipine or Urapidil
| Study group | Role | What they receive |
|---|---|---|
| Nicardipine | Major patients hospitalized in intensive care unit, with systolic hypertension, requiring administration of intravenous Nicardipine. Receives: Drug: Antihypertensive Agents | |
| Urapidil | Major patients hospitalized in intensive care unit, with systolic hypertension, requiring administration of intravenous Urapidil. Receives: Drug: Antihypertensive Agents |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypoxemia
Occurrence of worsening of hypoxemia
Measured: During the twelve hours following start of drug infusion
Secondary outcomes (1)
Efficacy of antihypertensive action
Time before the drop of arterial systolic blood pressure below 140mmHg
Measured: During the twelve hours following start of drug infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2021
- Study start15 Nov 2021
- Primary completion15 Nov 2023
- Study completion15 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hypoxemic Respiratory FailureStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05155202
- Sponsor's protocol ID
- ID2885
- Acronym
- ECRHIN-ICU
- Status last verified
- Feb 2023
- First submitted
- 1 Dec 2021
- Last updated
- 13 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Suard F, Mombrun M, Fischer MO, Hanouz JL, Decros JB, Derville S, Gakuba C, Al Issa G, Menard C, Chretien B, Descamps R. Oxygenation Effects of Antihypertensive Agents in Intensive Care: A Prospective Comparative Study of Nicardipine and Urapidil. Clin Pharmacol Ther. 2025 Mar;117(3):742-748. doi: 10.1002/cpt.3509. Epub 2024 Nov 27.
PubMed 39604146
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Relevance of Nicardipine Induced Hypoxemia in the Intensive Care Unit. A Multicenter Prospective Observational Study Comparing Nicardipine and Urapidil
- ClinicalTrials.gov ID
- NCT05155202
- Acronym / sponsor ID
- ECRHIN-ICU / ID2885
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 15 Nov 2021 (actual)
- Primary completion
- 15 Nov 2023 (actual)
- Study completion
- 15 Oct 2024 (estimated)
- First posted
- 13 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nicardipine | – | Drug: Antihypertensive AgentsMajor patients hospitalized in intensive care unit, with systolic hypertension, requiring administration of intravenous Nicardipine. |
| Urapidil | – | Drug: Antihypertensive AgentsMajor patients hospitalized in intensive care unit, with systolic hypertension, requiring administration of intravenous Urapidil. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All hypertensive patients in the intensive care unit
Key inclusion criteria (3 listed)
- Major patient
- With acute arterial systolic hypertension over 140mmHg
- Requiring intravenous administration of one of the two following drugs : Urapidil or Nicardipine
Key exclusion criteria (4 listed)
- Patient ventilated Under Nitrogen Monoxyde
- Contraindication to Nicardipine or Urapidil
- Refusal of the patient or his relatives
- Patient treated for pulmonary hypertension
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Antihypertensive AgentsAdministration of intravenous Nicardipine or Urapidil | Drug | Nicardipine, Urapidil |
Primary outcome
Hypoxemia
Time frame: During the twelve hours following start of drug infusion
Occurrence of worsening of hypoxemia
1 secondary outcome
Efficacy of antihypertensive action
Time frame: During the twelve hours following start of drug infusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2024.
- Derived from this study: PubMed 39604146Suard F, Mombrun M, Fischer MO, Hanouz JL, Decros JB, Derville S, Gakuba C, Al Issa G, Menard C, Chretien B, Descamps R. Oxygenation Effects of Antihypertensive Agents in Intensive Care: A Prospective Comparative Study of Nicardipine and Urapidil. Clin Pharmacol Ther. 2025 Mar;117(3):742-748. doi: 10.1002/cpt.3509. Epub 2024 Nov 27.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypoxemic Respiratory Failure and Side Effect, run by University Hospital, Caen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hypoxemia (time frame: During the twelve hours following start of drug infusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05155202, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2024; AzTrials last refreshed its copy on 8 Nov 2026.