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CHangeovers of Norepinephrine in Intensive Care (CHIC)

Primary Purpose

Shock, Intensive Care

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
changeover
use of automatic infusion pump
datas collection
Sponsored by
University Hospital, Angers
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Shock focused on measuring Norepinephrine, Intensive Care, Changeovers, Smart pumps, Quick change, Double pumping, Shock

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Le Roy

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Quick change

Double Pumping

Smart infusion pump

Arm Description

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.

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.

For this automatic changeover : When the syringe of norepinephrine stops (pre alarm), oversee the progress of the automatic relay.

Outcomes

Primary Outcome Measures

percentage of norepinephrine' syringes causing a change in the mean blood pressure over 15 mmHg

Secondary Outcome Measures

Percentage of norepinephrine syringe's relays causing a hypotension defined by a 15 mmHg decrease of the mean blood pressure
Percentage of norepinephrine syringe's relays causing a hypertension defined by a 15 mmHg increase of the mean blood pressure
Average time in minute spend by a nurse to change the syringe

Full Information

First Posted
November 24, 2014
Last Updated
March 15, 2019
Sponsor
University Hospital, Angers
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1. Study Identification

Unique Protocol Identification Number
NCT02304939
Brief Title
CHangeovers of Norepinephrine in Intensive Care
Acronym
CHIC
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.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Unknown status
Study Start Date
April 2015 (Actual)
Primary Completion Date
May 2017 (Actual)
Study Completion Date
June 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Angers

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shock, Intensive Care
Keywords
Norepinephrine, Intensive Care, Changeovers, Smart pumps, Quick change, Double pumping, Shock

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
285 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Quick change
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Double Pumping
Arm Type
Experimental
Arm Description
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.
Arm Title
Smart infusion pump
Arm Type
Experimental
Arm Description
For this automatic changeover : When the syringe of norepinephrine stops (pre alarm), oversee the progress of the automatic relay.
Intervention Type
Procedure
Intervention Name(s)
changeover
Intervention Type
Device
Intervention Name(s)
use of automatic infusion pump
Intervention Type
Behavioral
Intervention Name(s)
datas collection
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
Title
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
Title
Average time in minute spend by a nurse to change the syringe
Time Frame
15 minutes following the beginning of the relay

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Le Roy
City
Angers
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
32739045
Citation
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.
Results Reference
derived

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CHangeovers of Norepinephrine in Intensive Care

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