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

Critical Illness Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02828722
• Other study ID #: ACHROS CRC-003
• Status: Not yet recruiting
• Phase: N/A
• First received: July 5, 2016
• Last updated: July 7, 2016
• Start date: November 2016
• Est. completion date: June 2017

Study information

• Verified date: July 2016
• Source: Achros Health Technologies Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hungary: Scientific and Medical Research Council Ethics Committee
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 45
• Est. completion date: June 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Traumatic brain injury

• Multiple trauma

• Severe damage of the eye/optic nerve

• Blindness

• Post CPR

• Unlikely to survive 24 hours

• Involvement of the central nervous system (trauma, bleeding, infection, ischemia, etc.)

• Intracranial space occupying process

• Increased intracranial pressure

• Narcolepsy

• Huntington's disease

• Hypothermia

• Pregnancy

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Critical Illness
• Mechanical Ventilation

Intervention

Other:
• Controlled light and noise
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 nutrition
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.

Locations

Country	Name	City	State
Hungary	University of Szeged Faculty of Medicine, Department of Anaesthesiology and Intensive Therapy	Szeged

Sponsors (1)

Lead Sponsor	Collaborator
Achros Health Technologies Corporation

Country where clinical trial is conducted

Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change of the acute physiology and chronic health evaluation II (APACHE II) score from baseline to the end of the study treatment		during study participation but but no more than 10 days	No
Other	Change of the Sequential Organ Failure Assessment (SOFA) score from baseline to the end of the study treatment		during study participation but but no more than 10 days
Other	Change of the Simplified Acute Physiology II score (SAPS II) score from baseline to the end of the study treatment		during study participation but but no more than 10 days
Other	average daily dose of sedatives		during study participation but but no more than 10 days	No
Other	length of ICU treatment from admission to discharge in days		during study participation but no more than 99 days	No
Primary	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.	Over the ICU treatment period but no more than 10 days	No
Secondary	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.	Over the ICU treatment period but no more than 10 days	No
Secondary	Number of participants with gastric retention	Number of participants with at least 250ml gastric retention at least one time	over the ICU treatment period but no more than 10 days	No
Secondary	Number of participants with delirium	Number of participants with at least one evaluated Intensive Care Delirium Screening Checklist (ICDSC) score between 4-8	over the ICU treatment period but no more than 10 days	No