The Diversity of Intestinal Microbiota in Patients With Different Sedative-hypnotics Undergoing Mechanical Ventilation

NCT03401736 | Withdrawn DMC

• 1 other identifier: 2017-443-T339
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Bidirectional communication between the CNS and the GI tract - the brain-gut axis - occurs both in health and disease.Patients with mechanical ventilation in ICU (ICU) often meet the necessary nutritional needs. These patients often appear varying degrees of intestinal flora imbalance, such as diarrhea, vomiting, abdominal distension and other complications, which exert negative effect on treatment and prolong hospitalization time.So far，whether the sedative drugs used for a long time in mechanically ventilated patients will affect the diversity of intestinal flora or not has not been reported.The effects of different sedative drugs on the intestinal flora diversity need further study.Therefore, this topic will used midazolam and dexmedetomidine to study the effect on the diversity of intestinal microbiota.Meanwhile，the research will provide a theoretical basis for rational use of mechanical ventilation and sedative drugs.

Conditions

Intestinal Microbiota; Mechanical Ventilation

Keywords

Sedatives and Hypnotics

Outcome Measures

Primary Outcomes (1)

• The changing trends of the diversity of Intestinal microbiota

  Bacterial diversity revealed by 16S ribosomal RNA (rRNA) gene high-throughput sequencing (HTS).Feces were collected before operation from patients who had surgery.After the first collection, another was collected when the patient received mechanical ventilation more than 12 hours.

  Up to 1 year from the beginning of the study

Secondary Outcomes (3)

• The changing trends of weight

  Up to 1 month from the beginning of the study

• duration of sedation

  Time from achieving sedation until reaching full consciousness,up to 1 week.

• Duration of mechanical ventilation

  Up to 3 days from the beginning of the study

Study Arms (2)

Group M：received midazolam

EXPERIMENTAL

Patients who requires the mechanical ventilation allocated to the midazolam group (group M) were treated with an infusion bolus of 0.05 mg/kg and continuous infusion of 0.04 to 0.20 mg/kg/hour, with the dosage adjusted to achieve the desired level of sedation.

Device: Mechanical Ventilation; Drug: Midazolam

Group D: received dexmedetomidine

ACTIVE COMPARATOR

Patients who requires the mechanical ventilation allocated to the dexmedetomidine group (group D) received an infusion bolus of 1 ug/kg within 10 minutes and continuous infusion of 0.25 to 0.75 ug/kg/hour, with the dosage adjusted to achieve the desired level of sedation.All patients maintained BIS between 65\~85 and the Ramsay score was 3 to 4.

Device: Mechanical Ventilation; Drug: Dexmedetomidine

Interventions

Mechanical Ventilation DEVICE

Whether midazolam and dexmedetomidine have an effect on the diversity of intestinal microbiota or not is still unknown，especially the patient who requires the mechanical ventilation.

Group D: received dexmedetomidine; Group M：received midazolam

Midazolam DRUG

The impact of Midazolam on the diversity of intestinal microbiota.

Also known as: Midazolam injection

Group M：received midazolam

Dexmedetomidine DRUG

The impact of dexmedetomidine on the diversity of intestinal microbiota.

Also known as: Dexmedetomidine injection

Group D: received dexmedetomidine

Eligibility Criteria

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

You may qualify if:

• patients who receive long-term (≥12 hours) mechanical ventilation after operation on admission to the ICU
• APACHEII score 12-20 points
• no receive other clinical trials in the near 3 months
• no acute infectious disease, psychosis or other disease
• volunteer people

You may not qualify if:

• known or suspected allergy to midazolam or Dexmedetomidine
• suspected pregnancy, gross obesity, hyperlipemia, moribund state
• history of alcoholism or intake of anti-anxiety drugs or hypnotics
• chronic renal failure
• coma by cranial trauma or neurosurgery or unknown etiology or status epilepticus
• unwillingness to provide informed consent by patients or their authorized surrogates following ICU admission.

Sponsors & Collaborators

• Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University: lead

Study Sites (1)

Shanghai9 Hospital

Shanghai, Shanghai Municipality, China

Location

Related Publications (9)

• Mulak A, Bonaz B. Brain-gut-microbiota axis in Parkinson's disease. World J Gastroenterol. 2015 Oct 7;21(37):10609-20. doi: 10.3748/wjg.v21.i37.10609.

  PMID: 26457021 BACKGROUND

• Evrensel A, Ceylan ME. Fecal Microbiota Transplantation and Its Usage in Neuropsychiatric Disorders. Clin Psychopharmacol Neurosci. 2016 Aug 31;14(3):231-7. doi: 10.9758/cpn.2016.14.3.231.

  PMID: 27489376 BACKGROUND

• Al Omran Y, Aziz Q. The brain-gut axis in health and disease. Adv Exp Med Biol. 2014;817:135-53. doi: 10.1007/978-1-4939-0897-4_6.

  PMID: 24997032 BACKGROUND

• Luna RA, Savidge TC, Williams KC. The Brain-Gut-Microbiome Axis: What Role Does It Play in Autism Spectrum Disorder? Curr Dev Disord Rep. 2016 Mar;3(1):75-81. doi: 10.1007/s40474-016-0077-7. Epub 2016 Feb 26.

  PMID: 27398286 BACKGROUND

• Mayer EA, Padua D, Tillisch K. Altered brain-gut axis in autism: comorbidity or causative mechanisms? Bioessays. 2014 Oct;36(10):933-9. doi: 10.1002/bies.201400075. Epub 2014 Aug 22.

  PMID: 25145752 BACKGROUND

• Li Q, Zhou JM. The microbiota-gut-brain axis and its potential therapeutic role in autism spectrum disorder. Neuroscience. 2016 Jun 2;324:131-9. doi: 10.1016/j.neuroscience.2016.03.013. Epub 2016 Mar 8.

  PMID: 26964681 BACKGROUND

• van De Sande MM, van Buul VJ, Brouns FJ. Autism and nutrition: the role of the gut-brain axis. Nutr Res Rev. 2014 Dec;27(2):199-214. doi: 10.1017/S0954422414000110. Epub 2014 Jul 8.

  PMID: 25004237 BACKGROUND

• Atkinson W, Lockhart S, Whorwell PJ, Keevil B, Houghton LA. Altered 5-hydroxytryptamine signaling in patients with constipation- and diarrhea-predominant irritable bowel syndrome. Gastroenterology. 2006 Jan;130(1):34-43. doi: 10.1053/j.gastro.2005.09.031.

  PMID: 16401466 BACKGROUND

• Dizdar V, Spiller R, Singh G, Hanevik K, Gilja OH, El-Salhy M, Hausken T. Relative importance of abnormalities of CCK and 5-HT (serotonin) in Giardia-induced post-infectious irritable bowel syndrome and functional dyspepsia. Aliment Pharmacol Ther. 2010 Apr;31(8):883-91. doi: 10.1111/j.1365-2036.2010.04251.x. Epub 2010 Feb 2.

  PMID: 20132151 BACKGROUND

Related Links

• Dexmedetomidine vs midazolam for sedation of critically ill patients: a randomized trial

MeSH Terms

Interventions

Respiration, Artificial; Midazolam; Dexmedetomidine

Intervention Hierarchy (Ancestors)

Airway Management; Therapeutics; Resuscitation; Emergency Treatment; Respiratory Therapy; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring

Study Officials

• Li Jing Jie, M.D.

  Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: December 16, 2017
• First Posted: January 17, 2018
• Study Start: March 1, 2018
• Primary Completion: October 31, 2020
• Study Completion: November 1, 2020
• Last Updated: September 28, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)