Antihypertensive Drugs in ICUCUICUI-AHDNCT04924946
Current Use in Intensive Care Units by Intensivists of Antihypertensive Drugs
An observational study of Antihypertensive Drugs in ICU, run by Assistance Publique - Hôpitaux de Paris at 7 sites in France.
Trial summary
Multicenter, prospective and observational study of practices and impacts of the use of antihypertensive therapies in intensive medicine and intensive care Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Antihypertensive Drugs in ICU
- What is being tested?
- Inventory of prescribing habits and detect any differences in efficacy and tolerance of antihypertensive drugs
- How many people
- 200 participants
- Where
- 7 sitesFrance
- Study dates
- 1 Jun 2019to 1 Aug 2021
- 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
- Adult, Older adult
Study population: adult patients hospitalized in intensive care
Who may be able to join
- Adult patient
- Admitted to an intensive care unit
- Patient having presented a state of circulatory shock, defined by the need for continuous administration of a vasopressive amine for at least one hour, among: Noradrenaline, Adrenaline
- In whom the introduction of drug treatment for antihypertensive purposes is decided
Who cannot join
- Patient admitted to intensive care for a hypertensive emergency (hypertensive surge or malignant arterial hypertension leading to organ dysfunction
- Patient who has already received at least one anti-hypertensive drug during his stay in intensive care
- Cerebro-injured patient, proven or suspected cerebral edema, head trauma <1 month, decrease in cerebral perfusion measured
- Proven or suspected active bleeding
- Patient refusal of participation
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
France7 sites, 7 recruiting
- Recruiting
Intensive Care Victor Dupouy Hospital
Argenteuil, 95100
PLANTEFEVE Gaëtan, 0134232550, gaetan.plantefeve@ch-argenteuil.fr
- Recruiting
Intensive Care Avicenne Hsopital
Bobigny, 93000
GAUDRY Stephane, 01 48 96 44 55, stephane.gaudry@aphp.fr
- Recruiting
Intensive Care Louis Mourier Hospital
Colombes, 92700
FEDERICI Laura, 01 47 60 61 62, laura.federici@aphp.fr
- Recruiting
Intensive Care Longjumeau Hospital
Longjumeau, 91160
LEMEUR Matthieu, 01 64 54 33 33, m.lemeur@gh-nord-essonne.fr
- Recruiting
Intensive Care Bichat Hospital
Paris, 75018
SONNEVLLE Romain, 01 40 25 77 03, romain.sonneville@aphp.fr
- Recruiting
Intensive Care René Dubos Hospital
Pontoise, 95300
THIAGARAJAH Abirami, 01 30 75 40 40, abirami.thiagarajah@ght-novo.fr
- Recruiting
Intensive Care Tours Hospital
Tours, 37000
PEREZ Yonathan, 02 47 47 47 47, y.perez@chu-tours.fr
About this study
Multicenter, prospective and observational study of practices and impacts of the use of antihypertensive therapies in intensive medicine and intensive care
Read the detailed description
Multicenter, prospective observational cohort study on 200 patients, by doctor's questionnaire on the prescription of antihypertensive drugs in intensive care, follow-up over 72 hours of the prescription.
- Conditions
- Antihypertensive Drugs in ICU
- Being tested
- Inventory of prescribing habits and detect any differences in efficacy and tolerance of antihypertensive drugs
- Keywords
- intensive care, antihypertensive drugs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inventory of prescribing habits and detect any differences in efficacy and tolerance of antihypertensive drugsOther
- Time to monitor blood pressure values in target targets
- Need for administration of another antihypertensive drug
- Disappearance of organ failure attributable to hypertension
- Weaning from an extra-renal purification
- Weaning from mechanical ventilation
- Improved kidney function
- Iatrogenic hypotension
- Need for suspension of treatment
- Other side effect
What is being measured
The primary outcome is the main question the study is designed to answer.
Make an inventory of prescribing habits and detect any differences in efficacy and tolerance of antihypertensive drugs in intensive care and intensive care settings
Description in number of drugs
Measured: 60 days after inclusion
Make an inventory of prescribing habits and detect any differences in efficacy and tolerance of antihypertensive drugs in intensive care and intensive care settings
Description in percentage of drugs
Measured: 60 days after inclusion
Make an inventory of prescribing habits and detect any differences in efficacy and tolerance of antihypertensive drugs in intensive care and intensive care settings
therapeutic classes
Measured: 60 days after inclusion
Make an inventory of prescribing habits and detect any differences in efficacy and tolerance of antihypertensive drugs in intensive care and intensive care settings
administration methods
Measured: 60 days after inclusion
Make an inventory of prescribing habits and detect any differences in efficacy and tolerance of antihypertensive drugs in intensive care and intensive care settings
prescription chronology
Measured: 60 days after inclusion
Make an inventory of prescribing habits and detect any differences in efficacy and tolerance of antihypertensive drugs in intensive care and intensive care settings
reasons for prescribers
Measured: 60 days after inclusion
Secondary outcomes (9)
Search for efficiency differences between the different molecules
Time to control blood pressure values in the targeted targets
Measured: 60 days after inclusion
Search for efficiency differences between the different molecules
Need for administration of another antihypertensive drug
Measured: 60 days after inclusion
Search for efficiency differences between the different molecules
Disappearance of organ failure attributable to hypertension
Measured: 60 days after inclusion
Search for efficiency differences between the different molecules
Weaning from an extra-renal purification
Measured: 60 days after inclusion
Search for efficiency differences between the different molecules
Weaning from mechanical ventilation
Measured: 60 days after inclusion
Search for efficiency differences between the different molecules
Improved kidney function
Measured: 60 days after inclusion
Search for differences in side effects between the different molecules
Iatrogenic hypotension
Measured: 60 days after inclusion
Search for differences in side effects between the different molecules
Need for suspension of treatment
Measured: 60 days after inclusion
Search for differences in side effects between the different molecules
Other side effect
Measured: 60 days after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2021
- Study start1 Jun 2019
- Primary completion1 Jun 2019
- Study completion1 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Antihypertensive Drugs in ICUStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04924946
- Sponsor's protocol ID
- APHP191137
- Acronym
- CUICUI-AHD
- Status last verified
- Apr 2021
- First submitted
- 29 Apr 2021
- Last updated
- 14 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Current Use in Intensive Care Units by Intensivists of Antihypertensive Drugs
- ClinicalTrials.gov ID
- NCT04924946
- Acronym / sponsor ID
- CUICUI-AHD / APHP191137
- Conditions
- Antihypertensive Drugs in ICU
- Keywords
- intensive care, antihypertensive drugs
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 1 Jun 2019 (actual)
- Study completion
- 1 Aug 2021 (estimated)
- First posted
- 14 Jun 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.
Multicenter, prospective and observational study of practices and impacts of the use of antihypertensive therapies in intensive medicine and intensive care
Detailed description
Multicenter, prospective observational cohort study on 200 patients, by doctor's questionnaire on the prescription of antihypertensive drugs in intensive care, follow-up over 72 hours of the prescription.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- adult patients hospitalized in intensive care
Key inclusion criteria (4 listed)
- Adult patient
- Admitted to an intensive care unit
- Patient having presented a state of circulatory shock, defined by the need for continuous administration of a vasopressive amine for at least one hour, among: Noradrenaline, Adrenaline
- In whom the introduction of drug treatment for antihypertensive purposes is decided
Key exclusion criteria (5 listed)
- Patient admitted to intensive care for a hypertensive emergency (hypertensive surge or malignant arterial hypertension leading to organ dysfunction
- Patient who has already received at least one anti-hypertensive drug during his stay in intensive care
- Cerebro-injured patient, proven or suspected cerebral edema, head trauma <1 month, decrease in cerebral perfusion measured
- Proven or suspected active bleeding
- Patient refusal of participation
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 |
|---|---|---|
| Inventory of prescribing habits and detect any differences in efficacy and tolerance of antihypertensive drugs* Time to monitor blood pressure values in target targets * Need for administration of another antihypertensive drug * Disappearance of organ failure attributable to hypertension * Weaning from an extra-renal purification * Weaning from mechanical ventilation * Improved kidney function * Iatrogenic hypotension * Need for suspension of treatment * Other side effect | Other | – |
Primary outcome
Make an inventory of prescribing habits and detect any differences in efficacy and tolerance of antihypertensive drugs in intensive care and intensive care settings
Time frame: 60 days after inclusion
Description in number of drugs
Make an inventory of prescribing habits and detect any differences in efficacy and tolerance of antihypertensive drugs in intensive care and intensive care settings
Time frame: 60 days after inclusion
Description in percentage of drugs
Make an inventory of prescribing habits and detect any differences in efficacy and tolerance of antihypertensive drugs in intensive care and intensive care settings
Time frame: 60 days after inclusion
therapeutic classes
Make an inventory of prescribing habits and detect any differences in efficacy and tolerance of antihypertensive drugs in intensive care and intensive care settings
Time frame: 60 days after inclusion
administration methods
Make an inventory of prescribing habits and detect any differences in efficacy and tolerance of antihypertensive drugs in intensive care and intensive care settings
Time frame: 60 days after inclusion
prescription chronology
Make an inventory of prescribing habits and detect any differences in efficacy and tolerance of antihypertensive drugs in intensive care and intensive care settings
Time frame: 60 days after inclusion
reasons for prescribers
9 secondary outcomes
Search for efficiency differences between the different molecules
Time frame: 60 days after inclusion
Search for efficiency differences between the different molecules
Time frame: 60 days after inclusion
Search for efficiency differences between the different molecules
Time frame: 60 days after inclusion
Search for efficiency differences between the different molecules
Time frame: 60 days after inclusion
Search for efficiency differences between the different molecules
Time frame: 60 days after inclusion
Search for efficiency differences between the different molecules
Time frame: 60 days after inclusion
Search for differences in side effects between the different molecules
Time frame: 60 days after inclusion
Search for differences in side effects between the different molecules
Time frame: 60 days after inclusion
Search for differences in side effects between the different molecules
Time frame: 60 days after inclusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2021.
- Individual participant dataSharing planned: No
Related trials for Antihypertensive Drugs in ICU
Not yet recruiting
EIT Evaluation of Different Antihypertensive Agents on the Ventilation-Perfusion Ratio in Patients With Acute Respiratory Failure
Acute Respiratory Failure (ARF), Hypertension
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.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Antihypertensive Drugs in ICU, run by Assistance Publique - Hôpitaux de Paris at 7 sites 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 4 inclusion and 5 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 14 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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?
Contact GAUDRY Stephane (01 48 96 44 55, stephane.gaudry@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Make an inventory of prescribing habits and detect any differences in efficacy and tolerance of antihypertensive drugs in intensive care and intensive care settings (time frame: 60 days after inclusion). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Jun 2021.