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Assessment of Automatic Relays by Intensive Basis Advantage Compared With Manual Relays, on the Hypotension Risks, During Noradrenalin Administration (ARIBA)

Primary Purpose

Hypotension

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Measure of arterial pressure
Sponsored by
Centre Hospitalier Departemental Vendee
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Hypotension focused on measuring Noradrenalin relays, Automatic relays, Manual relays, Hypotension, Intensive care unit

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patient > 18 years,
  • Patient receiving only noradrenalin as catecholamine,
  • Collection of patient's non-objection or his trustworthy person, if appropriate.

Exclusion Criteria:

  • Pregnant or breast feeding patient,
  • Patient receiving an other treatment on the catecholamine way,
  • No affiliation at a social security,
  • Refusal of patient's trustworthy person or parent, if the patient is unable to give his non-objection.
  • Refusal of patient's participation when he is conscious,
  • Subjects deprived of liberty, under guardianship, hospitalized in a health facility or social or hospitalized without their consent,
  • Patients with secreting tumor, kind pheochromocytoma ou carcinoid tumor.

Sites / Locations

  • CHD Vendée

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Automatic relays

Manual relays

Arm Description

Automatic relays of noradrenalin using intensive basis.

Relays of noradrenalin using manual method

Outcomes

Primary Outcome Measures

Hypotension occurence defined as a decrease of 20% of the medium arterial pressure(MAP) between the baseline (MAP before the relay) and the minimal MAP in the fifteen minutes after the relay.

Secondary Outcome Measures

Number of relays where the medium arterial pressure (MAP) is decreased by 10% compared to baseline
Number of relays where the medium arterial pressure (MAP) is inferior to 50 millimeter of mercury (mmHg)
Number of hypotension in patients whose dose of noradrenalin is > 0,5 gamma/kg/min

Full Information

First Posted
May 18, 2010
Last Updated
November 20, 2012
Sponsor
Centre Hospitalier Departemental Vendee
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1. Study Identification

Unique Protocol Identification Number
NCT01127152
Brief Title
Assessment of Automatic Relays by Intensive Basis Advantage Compared With Manual Relays, on the Hypotension Risks, During Noradrenalin Administration
Acronym
ARIBA
Official Title
Assessment of Automatic Relays by Intensive Basis Advantage Compared With Manual Relays, on the Hypotension Risks, During Noradrenalin Administration
Study Type
Interventional

2. Study Status

Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
April 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Departemental Vendee

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Circulatory failures are the main cause of admissions in the intensive care unit. It is recommended to prescribe to these patients an intravenous injection of catecholamine to correct this dysfunction and to keep an hemodynamic stability. Electric pumps are used to administrate a continuous flow of drugs to patient. When a syringe of drugs ends, it is replaced by a full syringe, it is named "relay". This change may cause a flow interruption and hypotension. In the intensive care unit at departmental hospital (CHD) Vendee, the manual relays used in common practice will cause hemodynamic instabilities : hypotensions in 20% cases. Since 4 years, new devices are also used to make the relays. It is "smart pumps" allowing to manage automated the drug delays. This new method allows to not interrupt the drug flow. It could reduce the occurence of hypotension. A 50% decrease of relative number of hypotension will show that the use of automatic method is the most sure medical strategy. Our study want to compare manual and automatic method watching the variations of medium arterial pressure (MAP) during the fifteen minutes after the relay compared to baseline (MAP before the relay). Noradrenalin is the catecholamine most administrated so we choose to study only the relay for this drug.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypotension
Keywords
Noradrenalin relays, Automatic relays, Manual relays, Hypotension, Intensive care unit

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Automatic relays
Arm Type
Active Comparator
Arm Description
Automatic relays of noradrenalin using intensive basis.
Arm Title
Manual relays
Arm Type
Active Comparator
Arm Description
Relays of noradrenalin using manual method
Intervention Type
Procedure
Intervention Name(s)
Measure of arterial pressure
Intervention Description
Measure of arterial pressure will occur every five minutes during the thirty minutes before the relay and during the fifteen minutes after the relay.
Primary Outcome Measure Information:
Title
Hypotension occurence defined as a decrease of 20% of the medium arterial pressure(MAP) between the baseline (MAP before the relay) and the minimal MAP in the fifteen minutes after the relay.
Time Frame
every five minutes during the thirty minutes before the relay, during the fifteen minutes after the relay
Secondary Outcome Measure Information:
Title
Number of relays where the medium arterial pressure (MAP) is decreased by 10% compared to baseline
Time Frame
every five minutes during the thirty minutes before the relay, during the fifteen minutes after the relay
Title
Number of relays where the medium arterial pressure (MAP) is inferior to 50 millimeter of mercury (mmHg)
Time Frame
during the fifteen minutes after the relay
Title
Number of hypotension in patients whose dose of noradrenalin is > 0,5 gamma/kg/min
Time Frame
every five minutes during the thirty minutes before the relay, during the fifteen minutes after the relay

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient > 18 years, Patient receiving only noradrenalin as catecholamine, Collection of patient's non-objection or his trustworthy person, if appropriate. Exclusion Criteria: Pregnant or breast feeding patient, Patient receiving an other treatment on the catecholamine way, No affiliation at a social security, Refusal of patient's trustworthy person or parent, if the patient is unable to give his non-objection. Refusal of patient's participation when he is conscious, Subjects deprived of liberty, under guardianship, hospitalized in a health facility or social or hospitalized without their consent, Patients with secreting tumor, kind pheochromocytoma ou carcinoid tumor.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean Reignier, MD
Organizational Affiliation
CHD Vendée
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHD Vendée
City
La Roche sur Yon
State/Province
Vendée
ZIP/Postal Code
85925
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
26577132
Citation
Greau E, Lascarrou JB, Le Thuaut A, Maquigneau N, Alcourt Y, Coutolleau A, Rousseau C, Erragne V, Reignier J. Automatic versus manual changeovers of norepinephrine infusion pumps in critically ill adults: a prospective controlled study. Ann Intensive Care. 2015 Dec;5(1):40. doi: 10.1186/s13613-015-0083-7. Epub 2015 Nov 14.
Results Reference
derived

Learn more about this trial

Assessment of Automatic Relays by Intensive Basis Advantage Compared With Manual Relays, on the Hypotension Risks, During Noradrenalin Administration

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