The Effects of Sedative on the Fluid Responsiveness in Critically Ill Patients
Primary Purpose
Shock, Sepsis
Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Passive Leg Raising
propofol or mexmedetomidine
Sponsored by
About this trial
This is an interventional prevention trial for Shock
Eligibility Criteria
Inclusion Criteria:
- patients with at least one of the clinical manifestations of acute circulatory failure; patients undergoing dexmedetomidine or propofol infusion
Exclusion Criteria:
- 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
Sites / Locations
- Nanjing Zhong-Da Hospital, Southeast University School of Medicine
Outcomes
Primary Outcome Measures
the area under ROC curve to predict hypotension
area under ROC curve of blood pressure changes during PLR to predict hypotension during sedation
Secondary Outcome Measures
Full Information
NCT ID
NCT01447875
First Posted
October 5, 2011
Last Updated
January 28, 2014
Sponsor
Southeast University, China
1. Study Identification
Unique Protocol Identification Number
NCT01447875
Brief Title
The Effects of Sedative on the Fluid Responsiveness in Critically Ill Patients
Official Title
The Effects of Propofol and Dexmedetomidine Infusion on the Fluid Responsiveness in Critically Ill Patients
Study Type
Interventional
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Southeast University, China
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shock, Sepsis
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Other
Intervention Name(s)
Passive Leg Raising
Other Intervention Name(s)
Passive Leg Raising testing
Intervention Description
elevation of both legs to a 45 degrees for about 1-2 minute before sedation
Intervention Type
Drug
Intervention Name(s)
propofol or mexmedetomidine
Primary Outcome Measure Information:
Title
the area under ROC curve to predict hypotension
Description
area under ROC curve of blood pressure changes during PLR to predict hypotension during sedation
Time Frame
60 min around passive leg raising test
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients with at least one of the clinical manifestations of acute circulatory failure; patients undergoing dexmedetomidine or propofol infusion
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tao Yu
Organizational Affiliation
Nanjing Zhong-Da Hospital, Southeast University
Official's Role
Study Director
Facility Information:
Facility Name
Nanjing Zhong-Da Hospital, Southeast University School of Medicine
City
Nanjing
ZIP/Postal Code
210009
Country
China
12. IPD Sharing Statement
Learn more about this trial
The Effects of Sedative on the Fluid Responsiveness in Critically Ill Patients
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