Back to resultsThe Effect of Midazolam on Fluid Responsiveness in Septic Patients
Primary Purpose
Septic Shock
Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
sedatives(Midazolam and Propofol)
Sponsored by
About this trial
This is an interventional treatment trial for Septic Shock focused on measuring septic shock, sepsis, fluid responsiveness, Midazolam, Propofol, haemodynamics
Eligibility Criteria
Patients are included if they meet the following inclusion criteria:
- Above 18 years old
- Endotracheal intubated and mechanical ventilated
- Awake, can communicate with researchers
- Diagnosed as septic shock. The definition of septic shock was clarified in Year 2001 ACCP/SCCM guidelines
- Within 24 hours after the EGDT resuscitation goals are achieved
- Informed consent are signed.
Exclusion Criteria
- 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
Sites / Locations
- Department of Critical Care , Zhong-da Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Midazolam
Propofol
Arm Description
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 infuse at a loading dose of 0.5mg/kg，and 0.5-2.0mg/kg.h maintenance dose to achieve Ramsay score of 4
Outcomes
Primary Outcome Measures
percentage of participants with more than 10% increase of cardiac index by passive leg raising after sedation
Secondary Outcome Measures
Full Information
NCT ID
NCT02050893
First Posted
March 5, 2013
Last Updated
January 30, 2014
Sponsor
Southeast University, China
1. Study Identification
Unique Protocol Identification Number
NCT02050893
Brief Title
The Effect of Midazolam on Fluid Responsiveness in Septic Patients
Study Type
Interventional
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
April 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Septic Shock
Keywords
septic shock, sepsis, fluid responsiveness, Midazolam, Propofol, haemodynamics
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Midazolam
Arm Type
Experimental
Arm Description
Midazolam infused at a 0.03mg/kg loading dose ,and 0.02-0.1mg/kg.h maintenance dose to achieve Ramsay score of 4
Arm Title
Propofol
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
sedatives(Midazolam and Propofol)
Primary Outcome Measure Information:
Title
percentage of participants with more than 10% increase of cardiac index by passive leg raising after sedation
Time Frame
Baseline,after sedation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Patients are included if they meet the following inclusion criteria:
Above 18 years old
Endotracheal intubated and mechanical ventilated
Awake, can communicate with researchers
Diagnosed as septic shock. The definition of septic shock was clarified in Year 2001 ACCP/SCCM guidelines
Within 24 hours after the EGDT resuscitation goals are achieved
Informed consent are signed.
Exclusion Criteria
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
Facility Information:
Facility Name
Department of Critical Care , Zhong-da Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
(86)210009
Country
China
12. IPD Sharing Statement
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The Effect of Midazolam on Fluid Responsiveness in Septic Patients
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