ShockCHICNCT02304939
CHangeovers of Norepinephrine in Intensive Care
A study testing changeover, use of automatic infusion pump and datas collection in people with Shock and Intensive Care, run by University Hospital, Angers at 1 site in France.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shock, Intensive Care
- What is being tested?
- changeover, use of automatic infusion pump and datas collection
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 285 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2015to Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Admission in Intensive Care Unit
- Norepinephrine perfusion started for less than three hours in ICU
- Invasive monitoring of blood pressure
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
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
Read the 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
- Being tested
- changeover, use of automatic infusion pump, datas collection
- Keywords
- Norepinephrine, Intensive Care, Changeovers, Smart pumps, Quick change, Double pumping, Shock
- Medical subject headings
- Shock
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
changeoverProcedure or surgery
use of automatic infusion pumpDevice
datas collectionBehavioural
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: changeover; Behavioral: 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. Receives: Procedure: changeover; Behavioral: 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. Receives: Procedure: changeover; Device: use of automatic infusion pump; Behavioral: datas collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage of norepinephrine' syringes causing a change in the mean blood pressure over 15 mmHg
Measured: 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
Measured: 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
Measured: in the 15 minutes following the beginning of the relay
Average time in minute spend by a nurse to change the syringe
Measured: 15 minutes following the beginning of the relay
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2014 (estimated)
- Study startApr 2015
- Primary completionMay 2017
- Study completionJun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ShockStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 285 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02304939
- Sponsor's protocol ID
- PHRIP-2013
- Other IDs
- 2014-A00591-46
- Acronym
- CHIC
- Status last verified
- Mar 2019
- First submitted
- 24 Nov 2014
- Last updated
- 19 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 32739045
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02304939
- Acronym / sponsor ID
- CHIC / PHRIP-2013
- Conditions
- Shock, Intensive Care
- Keywords
- Norepinephrine, Intensive Care, Changeovers, Smart pumps, Quick change, Double pumping, Shock
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 285 participants (actual)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- Apr 2015 (actual)
- Primary completion
- May 2017 (actual)
- Study completion
- Jun 2019 (estimated)
- First posted
- 2 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Quick change | Active comparator | Procedure: changeover, Behavioral: datas collectionFor 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. |
| Double Pumping | Experimental | Procedure: changeover, Behavioral: datas collectionFor 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. |
| Smart infusion pump | Experimental | Procedure: changeover, Device: use of automatic infusion pump, Behavioral: datas collectionFor this automatic changeover : When the syringe of norepinephrine stops (pre alarm), oversee the progress of the automatic relay. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Admission in Intensive Care Unit
- Norepinephrine perfusion started for less than three hours in ICU
- Invasive monitoring of blood pressure
Key exclusion criteria (7 listed)
- Age under 18
- Pregnant and breastfeeding women
- Previous participation in the trial
- No registration in any health care system
- Patient protected by law
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| changeover | Procedure or surgery | Double Pumping, Quick change, Smart infusion pump |
| use of automatic infusion pump | Device | Smart infusion pump |
| datas collection | Behavioural | Double Pumping, Quick change, Smart infusion pump |
Primary outcome
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
3 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2019.
- Derived from this study: PubMed 32739045Poiroux 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing changeover, use of automatic infusion pump and datas collection in people with Shock and Intensive Care, run by University Hospital, Angers at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02304939, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2019.