Circadian Dysrhythmia Clinical Trial
Official title:
Enhancement of Circadian Rhythms in ICU Patients Through Light Intervention
The investigators will examine the effects of dynamic light therapy on circadian rhythms in intensive care unit (ICU) patients. In a randomized controlled trial (RCT), they will investigate the effects of a specific light algorithm on rhythms of serum melatonin, clock gene expression, the proteome, and metabolome, compared to standard hospital lighting, supported by the data science algorithms to improve vital-based algorithms with light interventions.
Status | Not yet recruiting |
Enrollment | 40 |
Est. completion date | September 30, 2026 |
Est. primary completion date | March 30, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patient capable of giving consent or additionally existing legal caregiver or authorized/spouse representative in case of non-consenting patients in the intensive care unit - Male and female patients with age = 18 years - Expected intensive care unit stay = 5 days Exclusion Criteria: - Participation in other clinical studies during the study period and ten days before - Previous ICU treatment during the current hospital stay - Patients with psychiatric diseases - Patients with a history of stroke and known severe residual cognitive deficits - Patients with a history of cardiopulmonary arrest or pulseless electric activity with cardiopulmonary resuscitation followed by therapeutic hypothermia during entire hospital stay - Analphabetism - Anacusis or Hypoacusis with hearing aid device, - Amaurosis - Accommodation in an institution due to an official or judicial order - History of sleep-related breathing disorders - History or suspicion of hypoxic brain damage - History or suspicion of elevated intracranial pressure in the last 7 days before study inclusion - Patients with an open chest after cardiac surgery - Patient has a power of attorney or patient's provision, where he/she refuses participation in any clinical trial - The informed consent of the patient or the subject's legally acceptable representative can't be obtained in time - History of photoallergic reactions or history of visually triggered seizures - Severe eye diseases (e.g. retinopathy, glaucoma) or high sensitivity to bright light - Patients with liver cirrhosis - Patients with a probability of survival <24h |
Country | Name | City | State |
---|---|---|---|
Germany | Department of Anesthesiology and Intensive Care Medicine (CCM/CVK) | Berlin |
Lead Sponsor | Collaborator |
---|---|
Charite University, Berlin, Germany |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Circadian analyzes of routine high-output clinical data (Working package P1) | Relevant clinical data (routine and study data), which are associated with circadian rhythmicity | Before the start of this investigation | |
Primary | Rhythmicity of melatonin concentration | Prevalence of physiological circadian rhythmicity measured by serum melatonin concentrations. | Plasma melatonin levels will be assessed for a maximum of five 24-hour periods. | |
Secondary | Clock genes | Prevalence of physiological circadian rhythmicity measured by expression activity of clock genes. | Clock gene expression levels will be assessed for a maximum of five 24-hour periods. | |
Secondary | Metabolomics | Prevalence of physiological circadian rhythmicity measured by metabolomic concentrations. | Metabolomic measurements be assessed for a maximum of five 24-hour periods. | |
Secondary | Proteomics | Prevalence of physiological circadian rhythmicity measured by proteomic concentrations. | Proteomic measurements will be assessed for a maximum of five 24-hour periods. | |
Secondary | Inflammation parameters | Prevalence of physiological circadian rhythmicity measured by inflammation parameters (cytokines, chemokines, extracellular mitochondria concentrations. | Inflammation parameter levels will be assessed for a maximum of five 24-hour periods. | |
Secondary | Incidence of intensive care unit delirium | Delirium will be measured with the Confusion Assessment Method for the intensive care unit (CAM-ICU), Binary scale (Positive/Negative) | Participants will be followed up until discharge from the intensive care unit (maximum up to day 5) | |
Secondary | Delirium-free days in the intensive care unit | Delirium-free days will be measured in day without positive delirium scoring (Confusion Assessment Method for the intensive care unit (CAM-ICU), Binary scale (Negative)) | Participants will be followed up until discharge from the intensive care unit (maximum up to day 5) | |
Secondary | Delirium Severity | Delirium severity will be measured with the Intensive Care Delirium Screening Checklist (ICDSC). The higher the score the worse - higher score = higher delirium severity(ICDSC) | Participants will be followed up until discharge from the intensive care unit (maximum up to day 5) | |
Secondary | Depth of Sedation | Level of sedation will be measured with the Richmond Agitation-Sedation-Scale (RASS), -5 to +4, negative scores translates to a higher degree of sedation. | Participants will be followed up until discharge from the intensive care unit (maximum up to day 5) | |
Secondary | Level of analgesia 1 | Severity of pain will be measured with the Numeric Rating Scale (NRS). A higher score corresponds to a higher severity of pain.Score values from 0 to 10. A higher score means worse outcome. | Participants will be followed up until discharge from the intensive care unit (maximum up to day 5) | |
Secondary | Level of analgesia 2 | Severity of pain will be measured with the Visualized Numeric Rating Scale (NRS-V). A higher score corresponds to a higher severity of pain.Score values from 0 to 10. A higher score means worse outcome. | Participants will be followed up until discharge from the intensive care unit (maximum up to day 5) | |
Secondary | Level of analgesia 3 | Severity of pain will be measured with the Faces Pain Scale-Revised (FPS-R). A higher score corresponds to a higher severity of pain.Score values from 0 to 10. A higher score means worse outcome. | Participants will be followed up until discharge from the intensive care unit (maximum up to day 5) | |
Secondary | Level of analgesia 4 | Severity of pain will be measured with the Behavioral Pain Scale (BPS) . A higher score corresponds to a higher severity of pain.Score values from 3 to 12. A higher score means worse outcome. | Participants will be followed up until discharge from the intensive care unit (maximum up to day 5) | |
Secondary | Level of analgesia 5 | Severity of pain will be measured with the Behavioral Pain Scale for Non- Intubated (BPS-NI). A higher score corresponds to a higher severity of pain. A higher score corresponds to a higher severity of pain.Score values from 3 to 12. A higher score means worse outcome. | Participants will be followed up until discharge from the intensive care unit (maximum up to day 5) | |
Secondary | Total amount of opioids | Total amount of opioids administered per ICU treatment day will be measured in with morphine equivalents for each administered opioids. | Participants will be followed up until discharge from the intensive care unit (maximum up to day 5) | |
Secondary | Total amount of sedatives | Total amount of sedatives administered per ICU treatment day by dose summation for each sedative. | Participants will be followed up until discharge from the intensive care unit (maximum up to day 5) | |
Secondary | Duration of ventilation | Duration of invasive and non-invasive ventilation in hours | Participants will be followed up until discharge from the intensive care unit (maximum up to day 5) | |
Secondary | ICU length of stay | ICU length of stay will be measured in days | Participants will be followed up until ICU discharge, an expected average of 3 days. | |
Secondary | Hospital length of stay | Hospital length of stay will be measured in days | Participants will be followed up until hospital dischargean expected average of 7 days. | |
Secondary | Sepsis | Does patient fulfil sepsis criteria (Yes/No) | Participants will be followed up until discharge from the intensive care unit (maximum up to day 5) | |
Secondary | Septic shock | Does patient fulfil criteria for septic shock (Yes/No) | Participants will be followed up until discharge from the intensive care unit (maximum up to day 5) | |
Secondary | Sequential Organ Failure Assessment (SOFA-Score) | Predicts ICU mortality based on lab results and clinical data. . Score values between 0 and max. 24. Higher scores mean worse outcome. | Participants will be followed up until discharge from the intensive care unit (maximum up to day 5) | |
Secondary | Simplified Acute Physiology Score (SAPS II) | Estimates mortality in ICU patients, comparable to APACHE II.Score values between 0 and max. 163. Higher scores mean worse outcome. | Participants will be followed up until discharge from the intensive care unit (maximum up to day 5) | |
Secondary | Therapeutic Intervention Scoring System (TISS-28) | The Simplified Therapeutic Intervention Scoring System TISS-28 consists of 28 items. It is intended to accurately measure the level of care required for a patient in the Intensive Care Unit (ICU). Score values between 0 and max. 78. Higher scores mean higher level of required care for ICU patients. | Participants will be followed up until discharge from the intensive care unit (maximum up to day 5) | |
Secondary | Acute Physiological and Chronic Health Evaluation 2 Score (APACHE II) | The Acute Physiology and Chronic Health Evaluation (APACHE II) is a severity score and mortality estimation tool developed from a large sample of ICU patients in the United States.. Score values between 0 and max. 71. Higher scores mean worse outcome. | Participants will be followed up until discharge from the intensive care unit (maximum up to day 5) | |
Secondary | Medical Research Council (MRC) Score | The muscle scale grades muscle power on a scale of 0 to 5 (5= Muscle contracts normally against full resistance.; 0 = No movement is observed). | Participants will be followed up until discharge from the intensive care unit (maximum up to day 5) | |
Secondary | Hand strength measurements | Hand grip strength is measured with a dynometer. | Participants will be followed up until discharge from the intensive care unit (maximum up to day 5) | |
Secondary | Intensive Care Mobility Scale | To record the patient's highest level of mobility in the Intensive Care Unit. Scale from 0 to 10. 0 meaning no movement and 10 mean walking independently. | Participants will be followed up until discharge from the intensive care unit (maximum up to day 5) | |
Secondary | FIM Score (Functional Independence Measure) | FIMâ„¢ is comprised of 18 items, grouped into 2 subscales - motor and cognition. Each item is scored on a 7 point ordinal scale, ranging from a score of 1 to a score of 7. The higher the score, the more independent the patient is in performing the task associated with that item | Participants will be followed up until discharge from the intensive care unit (maximum up to day 5) | |
Secondary | Mean blood glucose (mg/dl) | Plasma glucose (PG) levels are determined by taking a blood sample from participants. It can be measured in mg/dL. | Participants will be followed up until discharge from the intensive care unit (maximum up to day 5) | |
Secondary | Blood glucose variability (SD in mg/dl) | Blood glucose variability (SD in mg/dl) represents how much glucose levels fluctuate over time from a given average. | Participants will be followed up until discharge from the intensive care unit (maximum up to day 5) | |
Secondary | Percentage of time in target glucose range (%) | Blood glucose levels outside the ranges listed in the blood sugar levels chart by age above are categorized as either high or low blood sugar. | Participants will be followed up until discharge from the intensive care unit (maximum up to day 5) | |
Secondary | Insulin requirement (IU/kg/h) | The amount of insuline is measured in units (IU). | Participants will be followed up until discharge from the intensive care unit (maximum up to day 5) | |
Secondary | Post Intensive Care Syndrome (PICS) | Binary scale (Positive/Negative). Diagnosis of "PICS" is defined by a new impairment or worsening of the health condition after intensive care unit stay and a clinically significant distress in at least one of the following outcome measurement instruments: Patient Health Questionnaires (PHQ-9, PHQ-8, PHQ-4), Generalized Anxiety Disorder Scales (GAD-2 and GAD-7), Impact of Event Scale Revised (IES-R), MiniCog, Animal Naming Test, Trail Making Test (TMT-A, TMT-B), Repeatable Battery for the Assessment of Neuropsychological Satus (RBANS), Timed Up-and-Go (TUG), Handgrip Strength, EQ-5D-5L, subjective assessment NRS, WHO Disability Assessment Schedule (WHODAS), Short Physical Performance Battery (SPPB). | Up to 6 months | |
Secondary | Analysis of the sleep architecture measured by polysomnography | Binary scale (Positive/Negative). All participants will be undergoing a polysomnography as part of their clinical care in the Post Intensive Care Syndrome ambulance. | Up to 6 months |
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