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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

Tracking Information
First Submitted Date  ICMJE November 24, 2014
First Posted Date  ICMJE December 2, 2014
Last Update Posted Date March 19, 2019
Actual Study Start Date  ICMJE April 2015
Actual Primary Completion Date May 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 27, 2014)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 27, 2014)
  • 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 ]
  • 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 ]
  • Average time in minute spend by a nurse to change the syringe [ Time Frame: 15 minutes following the beginning of the relay ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE CHangeovers of Norepinephrine in Intensive Care
Official Title  ICMJE 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.
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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Shock
  • Intensive Care
Intervention  ICMJE
  • Procedure: changeover
  • Device: use of automatic infusion pump
  • Behavioral: datas collection
Study Arms  ICMJE
  • 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.

    Interventions:
    • 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.

    Interventions:
    • 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.
    Interventions:
    • Procedure: changeover
    • Device: use of automatic infusion pump
    • Behavioral: datas collection
Publications * Poiroux L, Le Roy C, Ramelet AS, Le Brazic M, Messager L, Gressent A, Alcourt Y, Haubertin C, Hamel JF, Piquilloud L, Mercat A. Minimising haemodynamic lability during changeover of syringes infusing norepinephrine in adult critical care patients: a multicentre randomised controlled trial. Br J Anaesth. 2020 Oct;125(4):622-628. doi: 10.1016/j.bja.2020.06.041. Epub 2020 Jul 29.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Actual Enrollment  ICMJE
 (submitted: May 11, 2017)
285
Original Estimated Enrollment  ICMJE
 (submitted: November 27, 2014)
195
Estimated Study Completion Date  ICMJE June 2019
Actual Primary Completion Date May 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02304939
Other Study ID Numbers  ICMJE PHRIP-2013
2014-A00591-46 ( Other Identifier: ID RCB )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party University Hospital, Angers
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University Hospital, Angers
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University Hospital, Angers
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP