Organ ProtectionNCT02842437
Effects of Dexmedetomidine on Respiratory Function and Inflammatory Responses in Patient With Sepsis Undergoing Cleaning Focus of Infection
A study testing dexmedetomidine and normal saline in people with Organ Protection, run by General Hospital of Ningxia Medical University at 1 site in China.
Trial summary
The purpose of this study is to assess the efficacy of dexmedetomidine on lung protection in patient with sepsis undergoing cleaning focus of infection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Organ Protection
- What is being tested?
- dexmedetomidine and normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- Jul 2016to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patients with sepsis requiring abdominal cleaning focus of infection
- older than 18 years
- American Society of Anesthesiologists (ASA) physical status II-IV.
Who cannot join
- Bradycardia
- Atrioventricular block
- Allergic to the drugs
- A history of respiratory disease
- Pregnancy or breast-feeding women
Trial locations and contacts
1 site in 1 country.
China1 site
General Hospital of Ningxia Medical University
Yinchuan, Ningxia, 750004
Ma Hanxiang, +86-13519591508, mahanxiang@hotmail.com
About this study
The purpose of this study is to assess the efficacy of dexmedetomidine on lung protection in patient with sepsis undergoing cleaning focus of infection.
Read the detailed description
Sepsis is one of the most common, life-threatening medical conditions and is frequently complicated by organ failures, especially lung injury. It is well accepted that inflammatory reaction is the major cause of lung injury. Dexmedetomidine (Dex) is a novel α2-adrenoceptor agonist that is primarily used in surgical anesthesia and conscious-sedation. Recently, animal studies have shown that Dex plays an anti-inflammatory role, while it is not known whether Dex possesses any lung protective functions in patients with sepsis. Therefore, the aim of this study is to investigate the efficacy of Dex on lung protection in patient with sepsis undergoing cleaning focus of infection.
- Conditions
- Organ Protection
- Being tested
- dexmedetomidine, normal saline
- Keywords
- dexmedetomidine, sepsis, respiration
- Medical subject headings
- Sepsis, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dexmedetomidineDrug
receive a loading infusion of dexmedetomidine (1ug/kg) for 10min follow by a maintenance infusion (0.5ug/kg·h) continued until the end of the surgery
normal salineOther
receive matching placebo (equal volume of normal saline)
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine | Experimental | 25 patients receive a loading infusion of dexmedetomidine (1ug/kg) for 10min follow by a maintenance infusion (0.5ug/kg·h) continued until the end of the surgery Receives: Drug: dexmedetomidine |
| Placebo | Placebo comparator | 25 patients receive matching placebo （normal saline） Receives: Other: normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Alveolar-Arterial Oxygen Difference
Arterial blood samples were sampled before anesthesia for the alveolar-arterial oxygen difference by using blood gas analyzer.
Measured: Before anesthesia
The Oxygenation Index
Arterial blood samples were sampled before anesthesia for the oxygenation index by using blood gas analyzer.
Measured: Before anesthesia
The Respiratory Index
Arterial blood samples were sampled before anesthesia for the respiratory index by using blood gas analyzer.
Measured: Before anesthesia
The Alveolar-Arterial Oxygen Difference
Arterial blood samples were sampled at 3 minutes after the skin is sutured for the alveolar-arterial oxygen difference by using blood gas analyzer.
Measured: At 3 minutes after the skin is sutured
The Oxygenation Index
Arterial blood samples were sampled at 3 minutes after the skin is sutured for the oxygenation index by using blood gas analyzer.
Measured: At 3 minutes after the skin is sutured
The Respiratory Index
Arterial blood samples were sampled at 3 minutes after the skin is sutured for the respiratory index by using blood gas analyzer.
Measured: At 3 minutes after the skin is sutured
Secondary outcomes (3)
Change of tumor necrosis factor-α before anesthesia and after dexmedetomidine or placebo infusion instantly
Blood samples were sampled before anesthesia and at 3 minutes after the skin is sutured for the serum tumor necrosis factor-α，which were analyzed by using enzyme linked immunosorbent assay (ELISA).
Measured: Before anesthesia and at 3 minutes after the skin is sutured
Change of interleukin-1β before anesthesia and after dexmedetomidine or placebo infusion instantly
Blood samples were sampled before anesthesia and at 3 minutes after the skin is sutured for the interleukin-1β，which were analyzed by using enzyme linked immunosorbent assay (ELISA).
Measured: Before anesthesia and at 3 minutes after the skin is sutured
Change of the lactic acid before anesthesia and after dexmedetomidine or placebo infusion instantly
Arterial blood samples were sampled before anesthesia and at 3 minutes after the skin is sutured for the lactic acid by using blood gas analyzer.
Measured: Before anesthesia and at 3 minutes after the skin is sutured
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2016 (estimated)
- Study startJul 2016
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Organ ProtectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- General Hospital of Ningxia Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zhang Yonghai, Principal investigator, General Hospital of Ningxia Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02842437
- Sponsor's protocol ID
- XM2015071
- Status last verified
- Jul 2016
- First submitted
- 12 Jul 2016
- Last updated
- 22 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Dexmedetomidine on Respiratory Function and Inflammatory Responses in Patient With Sepsis Undergoing Cleaning Focus of Infection
- ClinicalTrials.gov ID
- NCT02842437
- Acronym / sponsor ID
- XM2015071
- Conditions
- Organ Protection
- Keywords
- dexmedetomidine, sepsis, respiration
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- General Hospital of Ningxia Medical UniversityUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 22 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the efficacy of dexmedetomidine on lung protection in patient with sepsis undergoing cleaning focus of infection.
Detailed description
Sepsis is one of the most common, life-threatening medical conditions and is frequently complicated by organ failures, especially lung injury. It is well accepted that inflammatory reaction is the major cause of lung injury. Dexmedetomidine (Dex) is a novel α2-adrenoceptor agonist that is primarily used in surgical anesthesia and conscious-sedation. Recently, animal studies have shown that Dex plays an anti-inflammatory role, while it is not known whether Dex possesses any lung protective functions in patients with sepsis. Therefore, the aim of this study is to investigate the efficacy of Dex on lung protection in patient with sepsis undergoing cleaning focus of infection.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine | Experimental | Drug: dexmedetomidine25 patients receive a loading infusion of dexmedetomidine (1ug/kg) for 10min follow by a maintenance infusion (0.5ug/kg·h) continued until the end of the surgery |
| Placebo | Placebo comparator | Other: normal saline25 patients receive matching placebo （normal saline） |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- The patients with sepsis requiring abdominal cleaning focus of infection
- older than 18 years
- American Society of Anesthesiologists (ASA) physical status II-IV.
Key exclusion criteria (5 listed)
- Bradycardia
- Atrioventricular block
- Allergic to the drugs
- A history of respiratory disease
- Pregnancy or breast-feeding women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dexmedetomidinereceive a loading infusion of dexmedetomidine (1ug/kg) for 10min follow by a maintenance infusion (0.5ug/kg·h) continued until the end of the surgery | Drug | Dexmedetomidine |
| normal salinereceive matching placebo (equal volume of normal saline) | Other | Placebo |
Primary outcome
The Alveolar-Arterial Oxygen Difference
Time frame: Before anesthesia
Arterial blood samples were sampled before anesthesia for the alveolar-arterial oxygen difference by using blood gas analyzer.
The Oxygenation Index
Time frame: Before anesthesia
Arterial blood samples were sampled before anesthesia for the oxygenation index by using blood gas analyzer.
The Respiratory Index
Time frame: Before anesthesia
Arterial blood samples were sampled before anesthesia for the respiratory index by using blood gas analyzer.
The Alveolar-Arterial Oxygen Difference
Time frame: At 3 minutes after the skin is sutured
Arterial blood samples were sampled at 3 minutes after the skin is sutured for the alveolar-arterial oxygen difference by using blood gas analyzer.
The Oxygenation Index
Time frame: At 3 minutes after the skin is sutured
Arterial blood samples were sampled at 3 minutes after the skin is sutured for the oxygenation index by using blood gas analyzer.
The Respiratory Index
Time frame: At 3 minutes after the skin is sutured
Arterial blood samples were sampled at 3 minutes after the skin is sutured for the respiratory index by using blood gas analyzer.
3 secondary outcomes
Change of tumor necrosis factor-α before anesthesia and after dexmedetomidine or placebo infusion instantly
Time frame: Before anesthesia and at 3 minutes after the skin is sutured
Change of interleukin-1β before anesthesia and after dexmedetomidine or placebo infusion instantly
Time frame: Before anesthesia and at 3 minutes after the skin is sutured
Change of the lactic acid before anesthesia and after dexmedetomidine or placebo infusion instantly
Time frame: Before anesthesia and at 3 minutes after the skin is sutured
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhang Yonghai principal investigator
General Hospital of Ningxia Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dexmedetomidine and normal saline in people with Organ Protection, run by General Hospital of Ningxia Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ma Hanxiang (+86-13519591508, mahanxiang@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Alveolar-Arterial Oxygen Difference (time frame: Before anesthesia). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2016.