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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01127152
Acronym
ARIBA
Enrollment
50
Registered
2010-05-20
Start date
2009-06-30
Completion date
2011-04-30
Last updated
2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypotension

Keywords

Noradrenalin relays, Automatic relays, Manual relays, Hypotension, Intensive care unit

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.

Interventions

PROCEDUREMeasure of arterial pressure

Measure of arterial pressure will occur every five minutes during the thirty minutes before the relay and during the fifteen minutes after the relay.

Sponsors

Centre Hospitalier Departemental Vendee
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
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.every five minutes during the thirty minutes before the relay, during the fifteen minutes after the relay

Secondary

MeasureTime frame
Number of relays where the medium arterial pressure (MAP) is decreased by 10% compared to baselineevery five minutes during the thirty minutes before the relay, during the fifteen minutes after the relay
Number of relays where the medium arterial pressure (MAP) is inferior to 50 millimeter of mercury (mmHg)during the fifteen minutes after the relay
Number of hypotension in patients whose dose of noradrenalin is > 0,5 gamma/kg/minevery five minutes during the thirty minutes before the relay, during the fifteen minutes after the relay

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026