CHangeovers of Norepinephrine in Intensive Care

NCT ID: NCT02304939

Last Updated: 2019-03-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 285 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-30
• Study Completion Date: 2019-06-30

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.

Conditions

Shock; Intensive Care

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

changeover

Intervention Type: PROCEDURE

datas collection

Intervention Type: BEHAVIORAL

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.

Group Type: EXPERIMENTAL

changeover

Intervention Type: PROCEDURE

datas collection

Intervention Type: BEHAVIORAL

Smart infusion pump

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

Group Type: EXPERIMENTAL

changeover

Intervention Type: PROCEDURE

use of automatic infusion pump

Intervention Type: DEVICE

datas collection

Intervention Type: BEHAVIORAL

Interventions

changeover

Intervention Type: PROCEDURE

use of automatic infusion pump

Intervention Type: DEVICE

datas collection

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Angers

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Le Roy

Angers, , France

Countries

France

References

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.

Reference Type: DERIVED

PMID: 32739045 (View on PubMed)

Other Identifiers

2014-A00591-46

Identifier Type: OTHER

Identifier Source: secondary_id

PHRIP-2013

Identifier Type: -

Identifier Source: org_study_id