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

November 20, 2012 updated by: Centre Hospitalier Departemental Vendee

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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.
Time Frame: every five minutes during the thirty minutes before the relay, during 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
Time Frame: every five minutes during the thirty minutes before the relay, during the fifteen minutes after the relay
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)
Time Frame: during the fifteen minutes after the relay
during the fifteen minutes after the relay
Number of hypotension in patients whose dose of noradrenalin is > 0,5 gamma/kg/min
Time Frame: every five minutes during the thirty minutes before the relay, during the fifteen minutes after the relay
every five minutes during the thirty minutes before the relay, during the fifteen minutes after the relay

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Departemental Vendee

Investigators

  • Principal Investigator: Jean Reignier, MD, CHD Vendée

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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 (Estimate)

May 20, 2010

Study Record Updates

Last Update Posted (Estimate)

November 21, 2012

Last Update Submitted That Met QC Criteria

November 20, 2012

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHD 010-09

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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