Current Use in Intensive Care Units by Intensivists of Antihypertensive Drugs (CUICUI-AHD)

Multicenter, prospective and observational study of practices and impacts of the use of antihypertensive therapies in intensive medicine and intensive care

Study Overview

• Status: Recruiting
• Conditions: Antihypertensive Drugs in ICU
• Intervention / Treatment: Other: Inventory of prescribing habits and detect any differences in efficacy and tolerance of antihypertensive drugs

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 Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: GAUDRY Stephane; Phone Number: 01 48 96 44 55; Email: stephane.gaudry@aphp.fr

Study Locations

• France
  • Argenteuil, France, 95100
    • Recruiting
    • Intensive Care Victor Dupouy Hospital
    • Contact: PLANTEFEVE Gaëtan; Phone Number: 0134232550; Email: gaetan.plantefeve@ch-argenteuil.fr
  • Bobigny, France, 93000
    • Recruiting
    • Intensive Care Avicenne Hsopital
    • Contact: GAUDRY Stephane; Phone Number: 01 48 96 44 55; Email: stephane.gaudry@aphp.fr
  • Colombes, France, 92700
    • Recruiting
    • Intensive Care Louis Mourier Hospital
    • Contact: FEDERICI Laura; Phone Number: 01 47 60 61 62; Email: laura.federici@aphp.fr
  • Longjumeau, France, 91160
    • Recruiting
    • Intensive Care Longjumeau Hospital
    • Contact: LEMEUR Matthieu; Phone Number: 01 64 54 33 33; Email: m.lemeur@gh-nord-essonne.fr
  • Paris, France, 75018
    • Recruiting
    • Intensive Care Bichat Hospital
    • Contact: SONNEVLLE Romain; Phone Number: 01 40 25 77 03; Email: romain.sonneville@aphp.fr
  • Pontoise, France, 95300
    • Recruiting
    • Intensive Care René Dubos Hospital
    • Contact: THIAGARAJAH Abirami; Phone Number: 01 30 75 40 40; Email: abirami.thiagarajah@ght-novo.fr
  • Tours, France, 37000
    • Recruiting
    • Intensive Care Tours Hospital
    • Contact: PEREZ Yonathan; Phone Number: 02 47 47 47 47; Email: y.perez@chu-tours.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

adult patients hospitalized in intensive care

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	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	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	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	60 days after inclusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Search for efficiency differences between the different molecules	Time to control blood pressure values in the targeted targets	60 days after inclusion
Search for efficiency differences between the different molecules	Need for administration of another antihypertensive drug	60 days after inclusion
Search for efficiency differences between the different molecules	Disappearance of organ failure attributable to hypertension	60 days after inclusion
Search for efficiency differences between the different molecules	Weaning from an extra-renal purification	60 days after inclusion
Search for efficiency differences between the different molecules	Weaning from mechanical ventilation	60 days after inclusion
Search for efficiency differences between the different molecules	Improved kidney function	60 days after inclusion
Search for differences in side effects between the different molecules	Iatrogenic hypotension	60 days after inclusion
Search for differences in side effects between the different molecules	Need for suspension of treatment	60 days after inclusion
Search for differences in side effects between the different molecules	Other side effect	60 days after inclusion

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2019
• Primary Completion (ACTUAL): June 1, 2019
• Study Completion (ANTICIPATED): August 1, 2021

Study Registration Dates

• First Submitted: April 29, 2021
• First Submitted That Met QC Criteria: June 7, 2021
• First Posted (ACTUAL): June 14, 2021

Study Record Updates

• Last Update Posted (ACTUAL): June 14, 2021
• Last Update Submitted That Met QC Criteria: June 7, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: intensive care; antihypertensive drugs
• Additional Relevant MeSH Terms: Antihypertensive Agents
• Other Study ID Numbers: APHP191137

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