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

Hypotension Clinical Trial

— ARIBA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01127152
• Other study ID #: CHD 010-09
• Status: Completed
• Phase: N/A
• First received: May 18, 2010
• Last updated: November 20, 2012
• Start date: June 2009
• Est. completion date: April 2011

Study information

• Verified date: June 2011
• Source: Centre Hospitalier Departemental Vendee
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Institutional Ethical CommitteeFrance: French Data Protection Authority
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: April 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Hypotension

Intervention

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.

Locations

Country	Name	City	State
France	CHD Vendée	La Roche sur Yon	Vendée

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Departemental Vendee

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes
Secondary	Number of relays where the medium arterial pressure (MAP) is inferior to 50 millimeter of mercury (mmHg)		during the fifteen minutes after the relay	Yes
Secondary	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	Yes