ArticleAnnals of intensive care2021
Serum melatonin concentration in critically ill patients randomized to sedation or non-sedation.
Article in Annals of intensive care, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01967680 (Non-sedation Versus Sedation With a Daily Wake-up Trial in Critically Ill Patients Receiving Mechanical Ventilation. The NONSEDA-trial. An Investigator-initiated, Randomised, Clinical, Parallel-group, Multinational, Superiority Trial), which is not on this map. Cited by 9 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Non-sedation Versus Sedation With a Daily Wake-up Trial in Critically Ill Patients Receiving Mechanical Ventilation. The NONSEDA-trial. An Investigator-initiated, Randomised, Clinical, Parallel-group, Multinational, Superiority Trial
Who cites it
9 citing papers in PubMed, 21 citations in OpenAlex.
- Sleep quality and quantity determined by polysomnography in mechanically ventilated critically ill patients randomized to dexmedetomidine or placebo.Acta anaesthesiologica Scandinavica · 2023Trial
- Delirium Management in Critical Care: Are We Moving Forward or Still Treading Water?Medical sciences (Basel, Switzerland) · 2025Review
- Delirium prevention requires more than melatonin: insights from the DEMEL trial.Intensive care medicine · 2025Article
- Unveiling the novel role of circadian rhythms in sepsis and septic shock: unexplored implications for chronotherapy.Frontiers in endocrinology · 2025Review
- A randomized controlled trial examining the impact of diversified nursing interventions on the circadian rhythm of sedated critically ill patients.Frontiers in medicine · 2025Article
- Prophylactic Melatonin for Delirium in Intensive Care Unit: An Updated Systematic Review and Meta-analysis of Randomized Controlled Trials.Indian journal of critical care medicine : peer-reviewed, official publication of Indian Society of Critical Care Medicine · 2023Review
- Enhancing circadian rhythms-the circadian MEGA bundle as novel approach to treat critical illness.Annals of translational medicine · 2023Review
- Circadian rhythm disturbance and delirium in ICU patients: a prospective cohort study.BMC anesthesiology · 2023Article
- Melatonin in ICU delirium: shining light on the hormone of darkness.Intensive care medicine · 2022Article
Corrections and comments
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Authors and funding
6 authors at 4 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundAbolished circadian rhythm is associated with altered cognitive function, delirium, and as a result increased mortality in critically ill patients, especially in those who are mechanically ventilated. The causes are multifactorial, of which changes in circadian rhythmicity may play a role. Melatonin plays a crucial role as part of the circadian and sleep/wake cycle. Whether sedation effects circadian regulation is unknown. Hence, the objective of this study was to evaluate the melatonin concentration in critically ill patients randomized to sedation or non-sedation and to investigate the correlation with delirium.
methodsAll patients were included and randomized at the intensive care unit at the hospital of southwest Jutland, Denmark. Seventy-nine patients completed the study (41 sedated and 38 non-sedated). S-melatonin was measured 3 times per day, (03.00, 14.00, and 22.00), for 4 consecutive days in total, starting on the second day upon randomization/intubation. The study was conducted as a sub-study to the NON-SEDA study in which one hundred consecutive patients were randomized to sedation or non-sedation with a daily wake-up call (50 in each arm). PRIMARY OUTCOME: melatonin concentration in sedated vs. non-sedated patients (analyzed using linear regression). Secondary outcome: risk of developing delirium or non-medically induced (NMI) coma in sedated vs. non-sedated patients, assessed by CAM-ICU (Confusion Assessment Method for the Intensive Care Unit) analyzed using logistic regression.
resultsMelatonin concentration was suppressed in sedated patients compared to the non-sedated. All patients experienced an elevated peak melatonin level early on in the course of their critical illness (p = 0.01). The risk of delirium or coma (NMI) was significantly lower in the non-sedated group (OR 0.42 CI 0.27; 0.66 p < 0.0001). No significant relationship between delirium development and suppressed melatonin concentration was established in this study (OR 1.004 p = 0.29 95% CI 0.997; 1.010).
conclusionMelatonin concentration was suppressed in sedated, critically ill patients, when compared to non-sedated controls and the frequency of delirium was elevated in sedated patients. Trail registration Clinicaltrials.gov (NCT01967680) on October 23, 2013.
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