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

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.

Study Overview

• Status: Completed
• Conditions: Hypotension
• Intervention / Treatment: Procedure: Measure of arterial pressure

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Vendée
    • La Roche-sur-Yon, Vendée, France, 85925
      • CHD Vendee

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Automatic relays; Automatic relays of noradrenalin using intensive basis.	Procedure: Measure 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.
Active Comparator: Manual relays; Relays of noradrenalin using manual method	Procedure: Measure 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time 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 Outcome Measures

Outcome Measure	Time Frame
Number of relays where the medium arterial pressure (MAP) is decreased by 10% compared to baseline	every 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/min	every five minutes during the thirty minutes before the relay, during the fifteen minutes after the relay

Collaborators and Investigators

• Sponsor: Centre Hospitalier Departemental Vendee
• Investigators: Principal Investigator: Jean Reignier, MD, CHD Vendee

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2009
• Primary Completion (Actual): February 1, 2011
• Study Completion (Actual): April 1, 2011

Study Registration Dates

• First Submitted: May 18, 2010
• First Submitted That Met QC Criteria: May 19, 2010
• First Posted (Estimated): May 20, 2010

Study Record Updates

• Last Update Posted (Estimated): November 17, 2025
• Last Update Submitted That Met QC Criteria: November 14, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Hypotension; Intensive care unit; Noradrenalin relays; Automatic relays; Manual relays
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Hypotension
• Other Study ID Numbers: CHD 010-09