NCT02304939

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
285

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 24, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 2, 2014

Completed
4 months until next milestone

Study Start

First participant enrolled

April 1, 2015

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

March 19, 2019

Status Verified

March 1, 2019

Enrollment Period

2.1 years

First QC Date

November 24, 2014

Last Update Submit

March 15, 2019

Conditions

ShockIntensive Care

Keywords

NorepinephrineIntensive CareChangeoversSmart pumpsQuick changeDouble pumpingShock

Outcome Measures

Primary Outcomes (1)

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

    in the 15 minutes following the beginning of the relay

Secondary Outcomes (3)

  • Percentage of norepinephrine syringe's relays causing a hypotension defined by a 15 mmHg decrease of the mean blood pressure

    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

    in the 15 minutes following the beginning of the relay

  • Average time in minute spend by a nurse to change the syringe

    15 minutes following the beginning of the relay

Study Arms (3)

Quick change

ACTIVE COMPARATOR

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: changeoverBehavioral: datas collection

Double Pumping

EXPERIMENTAL

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: changeoverBehavioral: datas collection

Smart infusion pump

EXPERIMENTAL

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

Procedure: changeoverDevice: use of automatic infusion pumpBehavioral: datas collection

Interventions

changeoverPROCEDURE
Double PumpingQuick changeSmart infusion pump
use of automatic infusion pumpDEVICE
Smart infusion pump
datas collectionBEHAVIORAL
Double PumpingQuick changeSmart infusion pump

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Le Roy

Angers, France

Location

Related Publications (1)

  • 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.

    PMID: 32739045DERIVED

MeSH Terms

Conditions

Shock

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 24, 2014

First Posted

December 2, 2014

Study Start

April 1, 2015

Primary Completion

May 1, 2017

Study Completion

June 1, 2019

Last Updated

March 19, 2019

Record last verified: 2019-03

Locations

FR(1)