The Effects of Sedative on the Fluid Responsiveness in Critically Ill Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01447875
Recruitment Status : Completed
First Posted : October 6, 2011
Last Update Posted : January 29, 2014
Information provided by (Responsible Party):
Tao Yu, Southeast University, China

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.

Condition or disease Intervention/treatment Phase
Shock Sepsis Other: Passive Leg Raising Drug: propofol or mexmedetomidine Phase 1

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Effects of Propofol and Dexmedetomidine Infusion on the Fluid Responsiveness in Critically Ill Patients
Study Start Date : May 2011
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Propofol
U.S. FDA Resources

Intervention Details:
    Other: Passive Leg Raising
    elevation of both legs to a 45 degrees for about 1-2 minute before sedation
    Other Name: Passive Leg Raising testing
    Drug: propofol or mexmedetomidine

Primary Outcome Measures :
  1. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01447875

Nanjing Zhong-Da Hospital, Southeast University School of Medicine
Nanjing, China, 210009
Sponsors and Collaborators
Southeast University, China
Study Director: Tao Yu Nanjing Zhong-Da Hospital, Southeast University

Responsible Party: Tao Yu, clinical doctor, Southeast University, China Identifier: NCT01447875     History of Changes
Other Study ID Numbers: 2011ZDLLKY02.1
First Posted: October 6, 2011    Key Record Dates
Last Update Posted: January 29, 2014
Last Verified: May 2012

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General