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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief 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.


Detailed Summary:
Sponsor: Centre Hospitalier Departemental Vendee

Current 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. [ Time Frame: every five minutes during the thirty minutes before the relay, during the fifteen minutes after the relay ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]
  • 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 ]
  • 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 ]


Original Secondary Outcome:

  • 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 ]
  • Number of relays where the medium arterial pressure (MAP) is inferior to 50mmHg [ Time Frame: 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 ]


Information By: Centre Hospitalier Departemental Vendee

Dates:
Date Received: May 18, 2010
Date Started: June 2009
Date Completion:
Last Updated: November 20, 2012
Last Verified: June 2011