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

NCT02828722 | Unknown

• 1 other identifier: ACHROS CRC-003
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Critical Illness; Mechanical Ventilation

Keywords

Circadian rhythm; Critical Illness; Mechanical ventilation; Environmental modulation

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Change of the MODS value (delta MODS) between worst and last score during the study treatment

  Over the ICU treatment period but no more than 10 days

• Number of participants with gastric retention

  over the ICU treatment period but no more than 10 days

• Number of participants with delirium

  over the ICU treatment period but no more than 10 days

Other Outcomes (5)

• 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

• 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

• 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

Study Arms (3)

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.

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.

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.

Interventions

Controlled light and noise OTHER

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.

Also known as: Environmental simulation of the daytime and night time alternation

Controlled light and noise; Controlled light, noise and nutrition

Controlled nutrition OTHER

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.

Also known as: Nutrition protocol that is in accordance with the daily rhythm

Controlled light, noise and nutrition

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Achros Health Technologies Corporation: lead

Study Sites (1)

University of Szeged Faculty of Medicine, Department of Anaesthesiology and Intensive Therapy

Szeged, Hungary

Location

MeSH Terms

Conditions

Critical Illness

Interventions

Noise

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sound; Radiation, Nonionizing; Radiation; Physical Phenomena; Environment; Ecological and Environmental Phenomena; Biological Phenomena; Environment and Public Health; Environmental Pollution; Public Health

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2016
• First Posted: July 12, 2016
• Study Start: November 1, 2016
• Primary Completion: April 1, 2017
• Study Completion: June 1, 2017
• Last Updated: July 12, 2016

Record last verified: 2016-07

Locations

HU (1)