Overview

This trial is active, not recruiting.

Conditions shock, intensive care
Treatments changeover, use of automatic infusion pump, datas collection
Sponsor University Hospital, Angers
Start date November 2014
End date January 2017
Trial size 195 participants
Trial identifier NCT02304939, 2014-A00591-46, PHRIP-2013

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose supportive care
Arm
(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.
changeover
datas collection
(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.
changeover
datas collection
(Experimental)
For this automatic changeover : When the syringe of norepinephrine stops (pre alarm), oversee the progress of the automatic relay.
changeover
use of automatic infusion pump
datas collection

Primary Outcomes

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

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

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.
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2014.
Information provided to ClinicalTrials.gov by University Hospital, Angers.