ClinicalTrials.Veeva

Menu

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

C

Centre Hospitalier Departemental Vendee

Status

Completed

Conditions

Hypotension

Treatments

Procedure: Measure of arterial pressure

Study type

Interventional

Funder types

Other

Identifiers

NCT01127152
CHD 010-09

Details and patient eligibility

About

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.

Enrollment

50 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

50 participants in 2 patient groups

Automatic relays
Active Comparator group
Description:
Automatic relays of noradrenalin using intensive basis.
Treatment:
Procedure: Measure of arterial pressure
Manual relays
Active Comparator group
Description:
Relays of noradrenalin using manual method
Treatment:
Procedure: Measure of arterial pressure

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems