Critical IllnessNCT02828722
Proof of Concept Trial to Confirm That the Recovery of Patients Treated in the Intensive Care Unit Requiring Mechanical Ventilation is Beneficially Affected by the Environmental Simulation of Daytime and Night Time Alternation as Well as by the Nutrition Protocol Corresponding to the Daily Rhythm
A study of Critical Illness and Mechanical Ventilation, run by Achros Health Technologies Corporation at 1 site in Hungary.
Trial summary
The purpose of this study is to determine whether the environmental simulation of daytime and night time alternation as well as by the nutrition protocol corresponding to the daily rhythm are beneficially affect the recovery of patients treated in the Intensive Care Unit (ICU) requiring mechanical ventilation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness, Mechanical Ventilation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteHungary
- Study dates
- Nov 2016to Jun 2017
- 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
- Male or female, 18 years or older
- Requiring treatment at the intensive care unit including mechanical ventilation
- Admission at the intensive care unit was done within 24 hours before randomization
- Written and signed patient information sheet and informed consent form obtained by the study participant or by his/her legal representative
Who cannot join
- Traumatic brain injury
- Multiple trauma
- Severe damage of the eye/optic nerve
- Blindness
- Post CPR
- Unlikely to survive 24 hours
Show all 13Show fewer
- Involvement of the central nervous system (trauma, bleeding, infection, ischemia, etc.)
- Intracranial space occupying process
- Increased intracranial pressure
- Narcolepsy
- Huntington's disease
- Hypothermia
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Hungary1 site
University of Szeged Faculty of Medicine, Department of Anaesthesiology and Intensive Therapy
Szeged
About this study
The purpose of this study is to determine whether the environmental simulation of daytime and night time alternation as well as by the nutrition protocol corresponding to the daily rhythm are beneficially affect the recovery of patients treated in the Intensive Care Unit (ICU) requiring mechanical ventilation.
Read the detailed description
The homeostasis of human body is significantly disturbed when organs' work-relax periods are not harmonized. Intensive Care Unit (ICU) patient's circadian rhythm is almost inevitably upset as a result of their disease and/or medical intervention. There are numerous animal studies prove that circadian rhythm and periodic dynamics are directly related to healing time and hence, mortality rate. Although, one of the main messengers of circadian synchronization is melatonin, it is overridden by temperature, and a number of other factors from e.g. the digestive tract. If the circadian rhythm is disturbed, the function of different organ systems becomes desynchronized and chaotic.
ICU environment and patient-care activities brings major drawbacks as well mainly by necessary presence of noise and light. It has been shown that ICU settings have an impact on patients' sleep, which can easily lead to delirium and circadian disruption. There are significant data showing strong correlation between delirium and ICU length of stay/ mortality.
The focus of this study is the environmental modulation at the ICU with controlled light, noise and nutrition conditions. Controlled light conditions are created with artificial light during daytime and sleeping mask during night time. Earplugs are used during night time for controlled noise conditions. Nutrition is carried out only during daytime both in case of enteral and parenteral feeding.
- Conditions
- Critical Illness, Mechanical Ventilation
- Being tested
- Controlled light and noise, Controlled nutrition
- Keywords
- Circadian rhythm, Critical Illness, Mechanical ventilation, Environmental modulation
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Controlled light and noiseOther
Also called Environmental simulation of the daytime and night time alternation
Purpose: The day-night ratio of the environmental illumination (limit 8 lux) and that of the noise level (limit 20 dBA) must correspond to the necessary value required by a healthy human body as defined by the National Sleep Foundation (USA).
Implementation: Simulation of the daytime period is performed with blue predominant artificial light with colour temperature between 5500 and 8000 K with lux values of 1000-1200 measured at the head of the patient. Simulation of the nighttime period is performed with a sleeping mask and earplugs.
Controlled nutritionOther
Also called Nutrition protocol that is in accordance with the daily rhythm
In compliance with the standard daily nutrition protocol, nutrition is carried out only during daytime both in case of enteral and parenteral feeding in accordance with European Society for Clinical Nutrition and Metabolism 2016 guidelines.
Nutritional regimen should be stopped for 8 hours/24 at night (non-nutritional period may be depending on the work schedule of the actual ICU) , even if the daily energy/protein target is not reached.
| Study group | Role | What they receive |
|---|---|---|
| Controlled light, noise and nutrition | Experimental | Simultaneously with the standard treatment performed at the clinical trial site environmental simulation of night time and daytime alternation as well as the nutrition protocol corresponding to the daily rhythm will be applied. Receives: Other: Controlled light and noise; Other: Controlled nutrition |
| Controlled light and noise | Experimental | Simultaneously with the standard treatment performed at the clinical trial site environmental simulation of night time and daytime alternation as well as the continuous nutrition (in accordance with the clinical trial site's standard practice) will be applied. Receives: Other: Controlled light and noise |
| Control | No intervention | The treatment of the study subject will be performed based on the clinical trial site's standard practice without environmental simulation or changes in the nutrition protocol. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of the Multiple Organ Dysfunction Score value (delta MODS) from baseline to the end of the study treatment
The primary efficacy endpoint is the change in MODS scale from baseline to the end of the study treatment period, i.e. deltaMODS. Since the length of ICU stay may be different for subjects, the MODS rate of change per day (deltaMODS/day) will be the primary measure to characterize the treatment effect.
Measured: Over the ICU treatment period but no more than 10 days
Secondary outcomes (3)
Change of the MODS value (delta MODS) between worst and last score during the study treatment
Change of the MODS value between worst and last score over the ICU treatment period but no longer than 10 days.
Measured: Over the ICU treatment period but no more than 10 days
Number of participants with gastric retention
Number of participants with at least 250ml gastric retention at least one time
Measured: over the ICU treatment period but no more than 10 days
Number of participants with delirium
Number of participants with at least one evaluated Intensive Care Delirium Screening Checklist (ICDSC) score between 4-8
Measured: over the ICU treatment period but no more than 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2016 (estimated)
- Study startNov 2016
- Primary completionApr 2017 (estimated)
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Achros Health Technologies Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02828722
- Sponsor's protocol ID
- ACHROS CRC-003
- Status last verified
- Jul 2016
- First submitted
- 5 Jul 2016
- Last updated
- 12 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proof of Concept Trial to Confirm That the Recovery of Patients Treated in the Intensive Care Unit Requiring Mechanical Ventilation is Beneficially Affected by the Environmental Simulation of Daytime and Night Time Alternation as Well as by the Nutrition Protocol Corresponding to the Daily Rhythm
- ClinicalTrials.gov ID
- NCT02828722
- Acronym / sponsor ID
- ACHROS CRC-003
- Conditions
- Critical Illness, Mechanical Ventilation
- Keywords
- Circadian rhythm, Critical Illness, Mechanical ventilation, Environmental modulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Achros Health Technologies CorporationIndustry (pharma, biotech, devices)
- Study start
- Nov 2016
- Primary completion
- Apr 2017 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 12 Jul 2016 (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.
The purpose of this study is to determine whether the environmental simulation of daytime and night time alternation as well as by the nutrition protocol corresponding to the daily rhythm are beneficially affect the recovery of patients treated in the Intensive Care Unit (ICU) requiring mechanical ventilation.
Detailed description
The homeostasis of human body is significantly disturbed when organs' work-relax periods are not harmonized. Intensive Care Unit (ICU) patient's circadian rhythm is almost inevitably upset as a result of their disease and/or medical intervention. There are numerous animal studies prove that circadian rhythm and periodic dynamics are directly related to healing time and hence, mortality rate. Although, one of the main messengers of circadian synchronization is melatonin, it is overridden by temperature, and a number of other factors from e.g. the digestive tract. If the circadian rhythm is disturbed, the function of different organ systems becomes desynchronized and chaotic.
ICU environment and patient-care activities brings major drawbacks as well mainly by necessary presence of noise and light. It has been shown that ICU settings have an impact on patients' sleep, which can easily lead to delirium and circadian disruption. There are significant data showing strong correlation between delirium and ICU length of stay/ mortality.
The focus of this study is the environmental modulation at the ICU with controlled light, noise and nutrition conditions. Controlled light conditions are created with artificial light during daytime and sleeping mask during night time. Earplugs are used during night time for controlled noise conditions. Nutrition is carried out only during daytime both in case of enteral and parenteral feeding.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Controlled light, noise and nutrition | Experimental | Other: Controlled light and noise, Other: Controlled nutritionSimultaneously with the standard treatment performed at the clinical trial site environmental simulation of night time and daytime alternation as well as the nutrition protocol corresponding to the daily rhythm will be applied. |
| Controlled light and noise | Experimental | Other: Controlled light and noiseSimultaneously with the standard treatment performed at the clinical trial site environmental simulation of night time and daytime alternation as well as the continuous nutrition (in accordance with the clinical trial site's standard practice) will be applied. |
| Control | No intervention | –The treatment of the study subject will be performed based on the clinical trial site's standard practice without environmental simulation or changes in the nutrition protocol. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female, 18 years or older
- Requiring treatment at the intensive care unit including mechanical ventilation
- Admission at the intensive care unit was done within 24 hours before randomization
- Written and signed patient information sheet and informed consent form obtained by the study participant or by his/her legal representative
Key exclusion criteria (13 listed)
- Traumatic brain injury
- Multiple trauma
- Severe damage of the eye/optic nerve
- Blindness
- Post CPR
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 |
|---|---|---|
| Controlled light and noiseAlso: Environmental simulation of the daytime and night time alternationPurpose: The day-night ratio of the environmental illumination (limit 8 lux) and that of the noise level (limit 20 dBA) must correspond to the necessary value required by a healthy human body as defined by the National Sleep Foundation (USA). Implementation: Simulation of the daytime period is performed with blue predominant artificial light with colour temperature between 5500 and 8000 K with lux values of 1000-1200 measured at the head of the patient. Simulation of the nighttime period is performed with a sleeping mask and earplugs. | Other | Controlled light and noise, Controlled light, noise and nutrition |
| Controlled nutritionAlso: Nutrition protocol that is in accordance with the daily rhythmIn compliance with the standard daily nutrition protocol, nutrition is carried out only during daytime both in case of enteral and parenteral feeding in accordance with European Society for Clinical Nutrition and Metabolism 2016 guidelines. Nutritional regimen should be stopped for 8 hours/24 at night (non-nutritional period may be depending on the work schedule of the actual ICU) , even if the daily energy/protein target is not reached. | Other | Controlled light, noise and nutrition |
Primary outcome
Change of the Multiple Organ Dysfunction Score value (delta MODS) from baseline to the end of the study treatment
Time frame: Over the ICU treatment period but no more than 10 days
The primary efficacy endpoint is the change in MODS scale from baseline to the end of the study treatment period, i.e. deltaMODS. Since the length of ICU stay may be different for subjects, the MODS rate of change per day (deltaMODS/day) will be the primary measure to characterize the treatment effect.
3 secondary outcomes
Change of the MODS value (delta MODS) between worst and last score during the study treatment
Time frame: Over the ICU treatment period but no more than 10 days
Number of participants with gastric retention
Time frame: over the ICU treatment period but no more than 10 days
Number of participants with delirium
Time frame: over the ICU treatment period but no more than 10 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2016.
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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 of Critical Illness and Mechanical Ventilation, run by Achros Health Technologies Corporation at 1 site in Hungary.
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 4 inclusion and 13 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 12 Jul 2016. 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 Hungary. 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?
Change of the Multiple Organ Dysfunction Score value (delta MODS) from baseline to the end of the study treatment (time frame: Over the ICU treatment period but no more than 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Jul 2016.