ShockPhase 1NCT01447875
The Effects of Sedative on the Fluid Responsiveness in Critically Ill Patients
A Phase 1 study testing Passive Leg Raising and propofol or mexmedetomidine in people with Shock and Sepsis, run by Southeast University, China at 1 site in China.
Trial summary
Hypotension and bradycardia are often observed following induction of dexmedetomidine or propofol sedation.Cardiac preload decrease by sedative agents was often considered as one of main causes for this hypotension.The investigators hypothesized that hypotension after induction of sedation is caused by decrease of… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- What is being tested?
- Passive Leg Raising and propofol or mexmedetomidine
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- May 2011to Dec 2013
- Phase
- Phase 1
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with at least one of the clinical manifestations of acute circulatory failure; patients undergoing dexmedetomidine or propofol infusion
Who cannot join
- deep venous thrombosis or elastic compression stocking
- an increase in the intra-abdominal pressure confirmed by clinical examination
- serious central nervous system pathology (head trauma, severe dementia, acute stroke, uncontrolled seizures)
- severe liver disease(Child-Pugh class C)
- unstable angina or acute myocardial infarction
- left ventricular ejection fraction less than 30%
- heart rate(HR) less than 50/min, heart block with second- or third degree
- systolic blood pressure (SBP) less than 90 mmHg despite 2 vasopressors infusion continuously before the begin of dexmedetomidine infusion
Trial locations and contacts
1 site in 1 country.
China1 site
Nanjing Zhong-Da Hospital, Southeast University School of Medicine
Nanjing, 210009
About this study
Official title: The Effects of Propofol and Dexmedetomidine Infusion on the Fluid Responsiveness in Critically Ill Patients
Hypotension and bradycardia are often observed following induction of dexmedetomidine or propofol sedation.Cardiac preload decrease by sedative agents was often considered as one of main causes for this hypotension.The investigators hypothesized that hypotension after induction of sedation is caused by decrease of preload by sedative agents,and passive leg raising (PLR)test could predict this event.Dexmedetomidine or propofol infusion in patients with circulatory failure decrease cardiac preload and enhance preload-dependency and fluid responsiveness.
Read the detailed description
In this clinical trial,the investigators hypothesized dexmedetomidine or propofol infusion in patients with circulatory failure decrease cardiac preload and enhanced preload-dependency and fluid responsiveness,and PLR induced pulse pressure variation (PLR-ΔPP) could predict the hypotension during dexmedetomidine induction in critically ill patients.Before dexmedetomidine or propofol infusion, the investigators will conduct passive leg raising test. At first, the patient's trunk was elevated 45 degrees for the first set of measurements. Then, the lower limbs were raised to a 45° angle while the patient's trunk was lowered to a supine position to measure peak BP (usually within 30-90 s). Hemodynamic profiles planned to be measured are SBP, DBP, CVP and HR.Sedation was induced with a dexmedetomidine 0.5μg/kg over 10 min loading, followed by a maintenance infusion of 0.2-0.7 μg/kg/h for one hour. The dose of propofol was titrated targeting the Richmond agitation sedation scale (RASS) ranged from -2 to -1 (bispectral index: 60-75).Hypotension was defined as a SBP less than 80 mmHg or DBP was less than 50 mmHg, or greater than 30% decrease from baseline for longer than 60 s. Bradycardia was defined a HR 50 /min or greater than 30% change from baseline for longer than 60 s. Receiver operator characteristic curve analysis was performed to evaluate sensitivity and specificity of the value PLR-ΔPP to detect patients at high risk of hypotension.
- Being tested
- Passive Leg Raising, propofol or mexmedetomidine
- Medical subject headings
- Shock, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Passive Leg RaisingOther
Also called Passive Leg Raising testing
elevation of both legs to a 45 degrees for about 1-2 minute before sedation
propofol or mexmedetomidineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
the area under ROC curve to predict hypotension
area under ROC curve of blood pressure changes during PLR to predict hypotension during sedation
Measured: 60 min around passive leg raising test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2011 (estimated)
- Study startMay 2011
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Southeast University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tao Yu, Southeast University, China
- Investigators
- Tao Yu, Study director, Nanjing Zhong-Da Hospital, Southeast University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01447875
- Sponsor's protocol ID
- 2011ZDLLKY02.1
- Status last verified
- May 2012
- First submitted
- 5 Oct 2011
- Last updated
- 29 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Propofol and Dexmedetomidine Infusion on the Fluid Responsiveness in Critically Ill Patients
- ClinicalTrials.gov ID
- NCT01447875
- Acronym / sponsor ID
- 2011ZDLLKY02.1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Southeast University, ChinaUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 6 Oct 2011 (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.
Hypotension and bradycardia are often observed following induction of dexmedetomidine or propofol sedation.Cardiac preload decrease by sedative agents was often considered as one of main causes for this hypotension.The investigators hypothesized that hypotension after induction of sedation is caused by decrease of preload by sedative agents,and passive leg raising (PLR)test could predict this event.Dexmedetomidine or propofol infusion in patients with circulatory failure decrease cardiac preload and enhance preload-dependency and fluid responsiveness.
Detailed description
In this clinical trial,the investigators hypothesized dexmedetomidine or propofol infusion in patients with circulatory failure decrease cardiac preload and enhanced preload-dependency and fluid responsiveness,and PLR induced pulse pressure variation (PLR-ΔPP) could predict the hypotension during dexmedetomidine induction in critically ill patients.Before dexmedetomidine or propofol infusion, the investigators will conduct passive leg raising test. At first, the patient's trunk was elevated 45 degrees for the first set of measurements. Then, the lower limbs were raised to a 45° angle while the patient's trunk was lowered to a supine position to measure peak BP (usually within 30-90 s). Hemodynamic profiles planned to be measured are SBP, DBP, CVP and HR.Sedation was induced with a dexmedetomidine 0.5μg/kg over 10 min loading, followed by a maintenance infusion of 0.2-0.7 μg/kg/h for one hour. The dose of propofol was titrated targeting the Richmond agitation sedation scale (RASS) ranged from -2 to -1 (bispectral index: 60-75).Hypotension was defined as a SBP less than 80 mmHg or DBP was less than 50 mmHg, or greater than 30% decrease from baseline for longer than 60 s. Bradycardia was defined a HR 50 /min or greater than 30% change from baseline for longer than 60 s. Receiver operator characteristic curve analysis was performed to evaluate sensitivity and specificity of the value PLR-ΔPP to detect patients at high risk of hypotension.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients with at least one of the clinical manifestations of acute circulatory failure; patients undergoing dexmedetomidine or propofol infusion
Key exclusion criteria (8 listed)
- deep venous thrombosis or elastic compression stocking
- an increase in the intra-abdominal pressure confirmed by clinical examination
- serious central nervous system pathology (head trauma, severe dementia, acute stroke, uncontrolled seizures)
- severe liver disease(Child-Pugh class C)
- unstable angina or acute myocardial infarction
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 |
|---|---|---|
| Passive Leg RaisingAlso: Passive Leg Raising testingelevation of both legs to a 45 degrees for about 1-2 minute before sedation | Other | – |
| propofol or mexmedetomidine | Drug | – |
Primary outcome
the area under ROC curve to predict hypotension
Time frame: 60 min around passive leg raising test
area under ROC curve of blood pressure changes during PLR to predict hypotension during 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 29 Jan 2014.
Related trials for Shock
Active, not recruiting
CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
Active, not recruitingPhase 4
Thymosin Alpha 1 and IgM Levels in Sepsis
Sepsis, Septic Shock
Not yet recruiting
Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
Acute-on-Chronic Liver Failure (ACLF)
RecruitingObservational study
Hemophagocytic Lymphohistiocytosis (HLH) Evaluation and Research of Clinical, ImmUnoLogic and TranscriptomE Study
Lymphohistiocytosis, Hemophagocytic, Secondary Hemophagocytic Lymphohistiocytosis
Active, not recruitingPhase 3
The Danish Out-of-Hospital Cardiac Arrest Study
Out-Of-Hospital Cardiac Arrest, Post-Cardiac Arrest Syndrome
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.
Tao Yu study director
Nanjing Zhong-Da Hospital, Southeast University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Passive Leg Raising and propofol or mexmedetomidine in people with Shock and Sepsis, 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 1 inclusion and 8 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 29 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 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.
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?
the area under ROC curve to predict hypotension (time frame: 60 min around passive leg raising test). 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 29 Jan 2014.