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

September 24, 2021 updated by: Jingjie Li, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

A Study on the Relationship Between Biodiversity of Intestinal Microbiota in Patients and Different Sedative-hypnotics Undergoing Mechanical Ventilation

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

There are a variety of normal microbial communities in the healthy human intestines, which maintain the physiological balance of the host. Under normal circumstances, there are about 104 intestinal microflora in the adult's intestines. The total number of genes is about 150 times the number of human genes. More and more studies have found that intestinal flora plays an important role in the occurrence of many human diseases. In recent years, the role of intestinal microflora in the brain axis has gradually been recognized and become a hot spot of research, and a new concept of the brain - gut axis is proposed.

The brain-gut axis is a bidirectional communication system between the central nervous system (CNS) and the gastrointestinal tract. Compared with ordinary mice, mild exposure to pressure can increase the level of corticosterone and adrenocorticotropic hormone in sterile mice, and this overreaction can be reversed by transplantation of normal rats' feces.Together, it is clear that the gut microbiota can be a key regulator of mood, cognition, pain, and obesity. Understanding microbiota-brain interactions is an exciting area of research which may contribute new insights into individual variations in cognition, personality, mood, sleep, and eating behavior.The abnormal expression of GABA (GABA) receptor in central nervous system is related to anxiety and depression. It is found that probiotics can regulate the expression of GABA receptor in the cerebral cortex through vagus nerve, thereby reducing anxiety and depression.5-HT signal system abnormalities may be associated with the pathophysiological changes of irritable bowel syndrome (IBS), while intestinal flora can affect the generation of neurotransmitter 5-HT in the intestine, resulting in changing of gastrointestinal motility and sensibility of internal organ. The above study means that the brain axis plays an important role in maintaining the diversity of intestinal microbiota.

It is essential that using sedatives to maintain the safety and comfort of the patient in ICU.Most patients also need receiving mechanical ventilation.Many patients in Intensive care unit appear varying degrees of intestinal microflora imbalance,especially received mechanical ventilation.So far,whether sedatives used for a long time in mechanically ventilated patients will affect the diversity of intestinal flora or not still not been reported. The effects of different sedative drugs on the intestinal flora diversity also need further study.Therefore, the topic will discuss the diversity of intestinal microbiota in patients with different sedative-hypnotics and mechanical ventilation.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China
        • Shanghai9 Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Group M：received midazolam
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
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.
Drug: Midazolam
The impact of Midazolam on the diversity of intestinal microbiota.
Other Names:
  • Midazolam injection
Active Comparator: Group D: received dexmedetomidine
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
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.
Drug: Dexmedetomidine
The impact of dexmedetomidine on the diversity of intestinal microbiota.
Other Names:
  • Dexmedetomidine injection

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The changing trends of the diversity of Intestinal microbiota
Time Frame: Up to 1 year from the beginning of the study
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The changing trends of weight
Time Frame: Up to 1 month from the beginning of the study
The changing trends of weight was recorded in kilograms by the experimental assistant
Up to 1 month from the beginning of the study
duration of sedation
Time Frame: Time from achieving sedation until reaching full consciousness,up to 1 week.
BIS and Ramsay score were described by the anesthetist physician
Time from achieving sedation until reaching full consciousness,up to 1 week.
Duration of mechanical ventilation
Time Frame: Up to 3 days from the beginning of the study
Duration of mechanical ventilation was described by the anesthetist physician
Up to 3 days from the beginning of the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Li Jing Jie, M.D., Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 31, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 16, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 16, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 17, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 28, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 24, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2017-443-T339

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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