Septic ShockPhase 1/2NCT02050893
The Effect of Midazolam on Fluid Responsiveness in Septic Patients
A Phase 1/2 study testing sedatives(Midazolam and Propofol) in people with Septic Shock, run by Southeast University, China at 1 site in China.
Trial summary
Fluid resuscitation remains the foundation for septic treatment.The evaluation of fluid responsiveness has significance in volume resuscitation for septic shock patients. As the sedative which is commonly used in ICU, Midazolam is supposed to change fluid responsiveness for the pharmacological effect of venodilation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Septic Shock
- What is being tested?
- sedatives(Midazolam and Propofol)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- May 2012to Apr 2013
- Phase
- Phase 1/2
- 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
None listed.
Who cannot join
- Under 18 years old
- Intra-abdominal hypertension
- Central nerves system dysfunction
- Heart failure and other cardiac dysfunction such as cardiac conduction block,acute coronary syndrome, cardiogenic shock
- Proof of volume overload or contradiction of fluid infusion
- Existence of arterial aneurysm, serious valvular disease,extensive peripheral vascular occlusion disease and insertion of artificial pacemaker
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Critical Care , Zhong-da Hospital
Nanjing, Jiangsu, (86)210009
About this study
Fluid resuscitation remains the foundation for septic treatment.The evaluation of fluid responsiveness has significance in volume resuscitation for septic shock patients. As the sedative which is commonly used in ICU, Midazolam is supposed to change fluid responsiveness for the pharmacological effect of venodilation. However, the hypothesis has not been certified clinically. In this research, the investigators aim to test the hypothesis that Midazolam can increase fluid responsiveness(using passive leg raising test) in septic shock patients.
- Conditions
- Septic Shock
- Being tested
- sedatives(Midazolam and Propofol)
- Keywords
- septic shock, sepsis, fluid responsiveness, Midazolam, Propofol, haemodynamics
- Medical subject headings
- Shock, Septic, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sedatives(Midazolam and Propofol)Drug
| Study group | Role | What they receive |
|---|---|---|
| Midazolam | Experimental | Midazolam infused at a 0.03mg/kg loading dose ,and 0.02-0.1mg/kg.h maintenance dose to achieve Ramsay score of 4 Receives: Drug: sedatives(Midazolam and Propofol) |
| Propofol | Experimental | Propofol infuse at a loading dose of 0.5mg/kg，and 0.5-2.0mg/kg.h maintenance dose to achieve Ramsay score of 4 Receives: Drug: sedatives(Midazolam and Propofol) |
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage of participants with more than 10% increase of cardiac index by passive leg raising after sedation
Measured: Baseline,after sedation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2014 (estimated)
- Study startMay 2012
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Septic ShockStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Southeast University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jianfeng Xie, Southeast University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02050893
- Sponsor's protocol ID
- fluid responsiveness
- Status last verified
- Jan 2014
- First submitted
- 5 Mar 2013
- Last updated
- 31 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Midazolam on Fluid Responsiveness in Septic Patients
- ClinicalTrials.gov ID
- NCT02050893
- Acronym / sponsor ID
- fluid responsiveness
- Conditions
- Septic Shock
- Keywords
- septic shock, sepsis, fluid responsiveness, Midazolam, Propofol, haemodynamics
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Southeast University, ChinaUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 31 Jan 2014 (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.
Fluid resuscitation remains the foundation for septic treatment.The evaluation of fluid responsiveness has significance in volume resuscitation for septic shock patients. As the sedative which is commonly used in ICU, Midazolam is supposed to change fluid responsiveness for the pharmacological effect of venodilation. However, the hypothesis has not been certified clinically. In this research, the investigators aim to test the hypothesis that Midazolam can increase fluid responsiveness(using passive leg raising test) in septic shock patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Midazolam | Experimental | Drug: sedatives(Midazolam and Propofol)Midazolam infused at a 0.03mg/kg loading dose ,and 0.02-0.1mg/kg.h maintenance dose to achieve Ramsay score of 4 |
| Propofol | Experimental | Drug: sedatives(Midazolam and Propofol)Propofol infuse at a loading dose of 0.5mg/kg，and 0.5-2.0mg/kg.h maintenance dose to achieve Ramsay score of 4 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (6 listed)
- Under 18 years old
- Intra-abdominal hypertension
- Central nerves system dysfunction
- Heart failure and other cardiac dysfunction such as cardiac conduction block,acute coronary syndrome, cardiogenic shock
- Proof of volume overload or contradiction of fluid infusion
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 |
|---|---|---|
| sedatives(Midazolam and Propofol) | Drug | Midazolam, Propofol |
Primary outcome
percentage of participants with more than 10% increase of cardiac index by passive leg raising after sedation
Time frame: Baseline,after sedation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2014.
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Sepsis
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing sedatives(Midazolam and Propofol) in people with Septic Shock, run by Southeast University, China 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 0 inclusion and 6 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: finished, as of the sponsor's last update on 31 Jan 2014. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
percentage of participants with more than 10% increase of cardiac index by passive leg raising after sedation (time frame: Baseline,after sedation). 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 31 Jan 2014.