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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2011-04-30

Brief Summary

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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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Detailed Description

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Conditions

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Hypotension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Automatic relays

Automatic relays of noradrenalin using intensive basis.

Group Type ACTIVE_COMPARATOR

Measure of arterial pressure

Intervention Type 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.

Manual relays

Relays of noradrenalin using manual method

Group Type ACTIVE_COMPARATOR

Measure of arterial pressure

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No