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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Tao Yu, Southeast University, China
ClinicalTrials.gov Identifier:
NCT01447875
First received: October 5, 2011
Last updated: January 28, 2014
Last verified: May 2012
  Purpose

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 Intervention Phase
Shock
Sepsis
Other: Passive Leg Raising
Drug: propofol or mexmedetomidine
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: The Effects of Propofol and Dexmedetomidine Infusion on the Fluid Responsiveness in Critically Ill Patients

Resource links provided by NLM:


Further study details as provided by Southeast University, China:

Primary Outcome Measures:
  • the area under ROC curve to predict hypotension [ Time Frame: 60 min around passive leg raising test ] [ Designated as safety issue: No ]
    area under ROC curve of blood pressure changes during PLR to predict hypotension during sedation


Enrollment: 100
Study Start Date: May 2011
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
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
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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01447875

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

No publications provided

Responsible Party: Tao Yu, clinical doctor, Southeast University, China
ClinicalTrials.gov Identifier: NCT01447875     History of Changes
Other Study ID Numbers: 2011ZDLLKY02.1
Study First Received: October 5, 2011
Last Updated: January 28, 2014
Health Authority: China: Ethics Committee

Additional relevant MeSH terms:
Critical Illness
Sepsis
Shock
Disease Attributes
Pathologic Processes
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Propofol
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Hypnotics and Sedatives

ClinicalTrials.gov processed this record on April 15, 2014