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

Condition(s) targeted: Hypotension

Intervention: Measure of arterial pressure (Procedure)

Phase: N/A

Status: Completed

Sponsored by: Centre Hospitalier Departemental Vendee

Official(s) and/or principal investigator(s):
Jean Reignier, MD, Principal Investigator, Affiliation: CHD Vendée

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.

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

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

Primary outcome: 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.

Secondary outcome:

Number of relays where the medium arterial pressure (MAP) is decreased by 10% compared to baseline

Number of relays where the medium arterial pressure (MAP) is inferior to 50 millimeter of mercury (mmHg)

Number of hypotension in patients whose dose of noradrenalin is > 0,5 gamma/kg/min

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

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

Starting date: June 2009
Last updated: November 20, 2012