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

NCT01127152 | Completed

• 1 other identifier: CHD 010-09
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypotension

Keywords

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

Outcome Measures

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.

  every five minutes during the thirty minutes before the relay, during the fifteen minutes after the relay

Secondary Outcomes (3)

• 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

Study Arms (2)

Automatic relays

ACTIVE COMPARATOR

Automatic relays of noradrenalin using intensive basis.

Procedure: Measure of arterial pressure

Manual relays

ACTIVE COMPARATOR

Relays of noradrenalin using manual method

Procedure: Measure of arterial pressure

Interventions

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.

Automatic relays; Manual relays

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Departemental Vendee: lead

Study Sites (1)

CHD Vendée

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

Location

Related Publications (1)

• 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.

  PMID: 26577132 RESULT

MeSH Terms

Conditions

Hypotension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Jean Reignier, MD

  CHD Vendée

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2010
• First Posted: May 20, 2010
• Study Start: June 1, 2009
• Primary Completion: February 1, 2011
• Study Completion: April 1, 2011
• Last Updated: November 17, 2025

Record last verified: 2025-11

Locations

FR (1)