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A pilot study on the melatonin treatment in patients with early septic shock: results of a single-center randomized controlled trial

BACKGROUND: We assessed the potential impact of a high dose of melatonin treatment in patients with early septic shock. METHODS: Forty patients with early septic shock were randomly allocated to the melatonin or placebo groups. Besides standard-of-care treatment, melatonin and placebo were administe...

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Autores principales: Taher, Abbas, Shokoohmand, Farnaz, Abdoli, Elham, Mohammadi, Younes, Mehrpooya, Maryam
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer International Publishing 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8408361/
https://www.ncbi.nlm.nih.gov/pubmed/34468959
http://dx.doi.org/10.1007/s11845-021-02758-1
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author Taher, Abbas
Shokoohmand, Farnaz
Abdoli, Elham
Mohammadi, Younes
Mehrpooya, Maryam
author_facet Taher, Abbas
Shokoohmand, Farnaz
Abdoli, Elham
Mohammadi, Younes
Mehrpooya, Maryam
author_sort Taher, Abbas
collection PubMed
description BACKGROUND: We assessed the potential impact of a high dose of melatonin treatment in patients with early septic shock. METHODS: Forty patients with early septic shock were randomly allocated to the melatonin or placebo groups. Besides standard-of-care treatment, melatonin and placebo were administered at a dose of 50 mg for five consecutive nights. The efficacy outcomes were severity of organ dysfunction based on the Sequential Organ Failure Assessment (SOFA) score, the number of patients requiring mechanical ventilation and ventilator-free days, the mean required vasopressor dose and vasopressor-free days, and 28 days all-cause mortality. RESULTS: After 5-day treatment, the mean SOFA scores decreased 4.05 ± 4.75 score in the melatonin group and 2.25 ± 4.87 in the placebo group. On day 28, 60% of the melatonin-treated patients and 35% of the placebo-treated patients had a SOFA score below six. Thirteen cases in the placebo group and nine cases in the melatonin group required mechanical ventilation; however, there was no statistically significant difference between the groups regarding these outcomes. The melatonin-treated patients had more ventilator-free days than placebo-treated patients over the 28-day (16.90 ± 9.24 vs. 10.00 ± 10.94; p value = 0.035). The mean reduction in the required dose of vasopressor was 6.2 ± 5.12 in the melatonin-treated patients compared to 3.20 ± 3.95 in the placebo-treated patients (p value = 0.045). Vasopressor-free days in the melatonin-treated group were also significantly more than the placebo-treated group (12.75 ± 7.43 days vs. 10.15 ± 6.12 days; p value = 0.046). CONCLUSIONS: Our pilot study supported the potential benefits of melatonin in treating septic shock. Further clinical evidence is required for expanding and confirming these findings. TRIAL REGISTRATION: The trial was registered at Clinicaltrials.gov (ID code: IRCT20120215009014N296). Registration date: 15/09/2019.
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spelling pubmed-84083612021-09-01 A pilot study on the melatonin treatment in patients with early septic shock: results of a single-center randomized controlled trial Taher, Abbas Shokoohmand, Farnaz Abdoli, Elham Mohammadi, Younes Mehrpooya, Maryam Ir J Med Sci Original Article BACKGROUND: We assessed the potential impact of a high dose of melatonin treatment in patients with early septic shock. METHODS: Forty patients with early septic shock were randomly allocated to the melatonin or placebo groups. Besides standard-of-care treatment, melatonin and placebo were administered at a dose of 50 mg for five consecutive nights. The efficacy outcomes were severity of organ dysfunction based on the Sequential Organ Failure Assessment (SOFA) score, the number of patients requiring mechanical ventilation and ventilator-free days, the mean required vasopressor dose and vasopressor-free days, and 28 days all-cause mortality. RESULTS: After 5-day treatment, the mean SOFA scores decreased 4.05 ± 4.75 score in the melatonin group and 2.25 ± 4.87 in the placebo group. On day 28, 60% of the melatonin-treated patients and 35% of the placebo-treated patients had a SOFA score below six. Thirteen cases in the placebo group and nine cases in the melatonin group required mechanical ventilation; however, there was no statistically significant difference between the groups regarding these outcomes. The melatonin-treated patients had more ventilator-free days than placebo-treated patients over the 28-day (16.90 ± 9.24 vs. 10.00 ± 10.94; p value = 0.035). The mean reduction in the required dose of vasopressor was 6.2 ± 5.12 in the melatonin-treated patients compared to 3.20 ± 3.95 in the placebo-treated patients (p value = 0.045). Vasopressor-free days in the melatonin-treated group were also significantly more than the placebo-treated group (12.75 ± 7.43 days vs. 10.15 ± 6.12 days; p value = 0.046). CONCLUSIONS: Our pilot study supported the potential benefits of melatonin in treating septic shock. Further clinical evidence is required for expanding and confirming these findings. TRIAL REGISTRATION: The trial was registered at Clinicaltrials.gov (ID code: IRCT20120215009014N296). Registration date: 15/09/2019. Springer International Publishing 2021-09-01 2022 /pmc/articles/PMC8408361/ /pubmed/34468959 http://dx.doi.org/10.1007/s11845-021-02758-1 Text en © Royal Academy of Medicine in Ireland 2021 This article is made available via the PMC Open Access Subset for unrestricted research re-use and secondary analysis in any form or by any means with acknowledgement of the original source. These permissions are granted for the duration of the World Health Organization (WHO) declaration of COVID-19 as a global pandemic.
spellingShingle Original Article
Taher, Abbas
Shokoohmand, Farnaz
Abdoli, Elham
Mohammadi, Younes
Mehrpooya, Maryam
A pilot study on the melatonin treatment in patients with early septic shock: results of a single-center randomized controlled trial
title A pilot study on the melatonin treatment in patients with early septic shock: results of a single-center randomized controlled trial
title_full A pilot study on the melatonin treatment in patients with early septic shock: results of a single-center randomized controlled trial
title_fullStr A pilot study on the melatonin treatment in patients with early septic shock: results of a single-center randomized controlled trial
title_full_unstemmed A pilot study on the melatonin treatment in patients with early septic shock: results of a single-center randomized controlled trial
title_short A pilot study on the melatonin treatment in patients with early septic shock: results of a single-center randomized controlled trial
title_sort pilot study on the melatonin treatment in patients with early septic shock: results of a single-center randomized controlled trial
topic Original Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8408361/
https://www.ncbi.nlm.nih.gov/pubmed/34468959
http://dx.doi.org/10.1007/s11845-021-02758-1
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