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Completed

NCT Number: NCT01127152

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

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.

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Key information

Conditions

Hypotension Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHD Vendée

La Roche-sur-Yon, Vendée, 85925, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Measure of arterial pressure

Procedure

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 outcomes

  1. 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 outcomes

  1. 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

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Departemental Vendee

Other

Registry information

Acronym: ARIBA

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
May 20, 2010
Registry last updated
Nov 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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