MedTrace Logo

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

NCT01127152 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-11-17

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Centre Hospitalier Departemental Vendee

    lead OTHER

Principal Investigators

  • Jean Reignier, MD · CHD Vendée

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-06-30
Primary Completion
2011-02-28
Completion
2011-04-30

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01127152 on ClinicalTrials.gov