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CHangeovers of Norepinephrine in Intensive Care (CHIC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02304939
Recruitment Status : Unknown
Verified March 2019 by University Hospital, Angers.
Recruitment status was:  Active, not recruiting
First Posted : December 2, 2014
Last Update Posted : March 19, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Angers

Brief Summary:

CHIC study's purpose is to compare the efficiency, in terms of blood pressure stability, of three changeovers of norepinephrine used routinely in ICU. The three techniques are:

  • Quick change
  • Double pumping
  • Smart infusion pumps

Condition or disease Intervention/treatment Phase
Shock Intensive Care Procedure: changeover Device: use of automatic infusion pump Behavioral: datas collection Not Applicable

Detailed Description:

The drugs used in intensive care units are numerous and their administration is based on a strong expertise in this context of urgency and complexity. Nurses role is not only to carry out preparation of a treatment but to implement a complex treatment that requires a risk management approach surpassing the simple task to which the decree of professional acts refers to.

In this context, the administration of catecholamines, widely used in intensive care medicine in the treatment of shock, appears to be a sensitive issue to study. These vasoactive drugs have a short half-life and a narrow therapeutic index. Administration should be careful ensuring both efficiency and prevention of complications such as hemodynamic instability or arrhythmias.

Administration of these therapeutic must be strictly continuous, that is to say delivered using electric syringe pumps. Syringe replacements appear as critical moments because of the risk of flow change or brief interruption of the infusion.

There are three main types of syringes relay techniques, but to date, no study has compared these techniques with each other. There is thus no recommendation based on objective datas to guide clinical nursing practice.

This study aims to provide evidence in order to secure the administration of catecholamines. It may also use as a reference for evaluation of new features that allow automation relays with called "smart pumps" and for which no study has demonstrated the added value in terms of security. No progress will be possible in securing the administration of drugs with a short half-life, narrow therapeutic index and significant side effects without a deep reflection of the conditions of their infusion. The choice of materials used and the development of care procedures must be based on reliable and timely recommendations. Patients expect safer care. Nurses must be able to have references enabling them to guide their practice to the benefit of patients.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 285 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Prospective, Randomized, Multi-center Trial Aiming to Determined the Impact of Changeovers of Norepinephrine on the Blood Pressure Stability With Patients in Shock in ICU.
Actual Study Start Date : April 2015
Actual Primary Completion Date : May 2017
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock

Arm Intervention/treatment
Active Comparator: Quick change

For this changeover : When the syringe of norepinephrine stops (pre alarm), start the second syringe pumps at the same speed of the first, wait for a first drop at the end of the tubing.

Close the first syringe, disconnect it and connect the second syringe, open the valve on and stop the first syringe.

Procedure: changeover
Behavioral: datas collection
Experimental: Double Pumping

For this changeover : When the syringe of norepinephrine stops (pre alarm), start the second syringe pumps, open the second syringe while leaving the first syringe open. Wait until the blood pressure rises 5 mmHg (SBP, DBP or MAP).

Once the blood pressure increased or 2 minutes from the start of the relay if no increase in blood pressure is observed, close the first syringe.

Procedure: changeover
Behavioral: datas collection
Experimental: Smart infusion pump
For this automatic changeover : When the syringe of norepinephrine stops (pre alarm), oversee the progress of the automatic relay.
Procedure: changeover
Device: use of automatic infusion pump
Behavioral: datas collection



Primary Outcome Measures :
  1. percentage of norepinephrine' syringes causing a change in the mean blood pressure over 15 mmHg [ Time Frame: in the 15 minutes following the beginning of the relay ]

Secondary Outcome Measures :
  1. Percentage of norepinephrine syringe's relays causing a hypotension defined by a 15 mmHg decrease of the mean blood pressure [ Time Frame: in the 15 minutes following the beginning of the relay ]
  2. Percentage of norepinephrine syringe's relays causing a hypertension defined by a 15 mmHg increase of the mean blood pressure [ Time Frame: in the 15 minutes following the beginning of the relay ]
  3. Average time in minute spend by a nurse to change the syringe [ Time Frame: 15 minutes following the beginning of the relay ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Admission in Intensive Care Unit
  • Norepinephrine perfusion started for less than three hours in ICU
  • Invasive monitoring of blood pressure

Exclusion Criteria:

  • Age under 18
  • Pregnant and breastfeeding women
  • Previous participation in the trial
  • No registration in any health care system
  • Patient protected by law
  • Patient study refusal
  • Active therapeutic limitation decision

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02304939


Locations
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France
Le Roy
Angers, France
Sponsors and Collaborators
University Hospital, Angers
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University Hospital, Angers
ClinicalTrials.gov Identifier: NCT02304939    
Other Study ID Numbers: PHRIP-2013
2014-A00591-46 ( Other Identifier: ID RCB )
First Posted: December 2, 2014    Key Record Dates
Last Update Posted: March 19, 2019
Last Verified: March 2019
Keywords provided by University Hospital, Angers:
Norepinephrine
Intensive Care
Changeovers
Smart pumps
Quick change
Double pumping
Shock
Additional relevant MeSH terms:
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Shock
Pathologic Processes