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

NCT01447875 | Completed Phase 1 DMC

• 1 other identifier: 2011ZDLLKY02.1
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Shock; Sepsis

Outcome Measures

Primary Outcomes (1)

• the area under ROC curve to predict hypotension

  area under ROC curve of blood pressure changes during PLR to predict hypotension during sedation

  60 min around passive leg raising test

Interventions

Passive Leg Raising OTHER

elevation of both legs to a 45 degrees for about 1-2 minute before sedation

Also known as: Passive Leg Raising testing

propofol or mexmedetomidine DRUG

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with at least one of the clinical manifestations of acute circulatory failure; patients undergoing dexmedetomidine or propofol infusion

You may not qualify if:

• 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

Sponsors & Collaborators

• Southeast University, China: lead

Study Sites (1)

Nanjing Zhong-Da Hospital, Southeast University School of Medicine

Nanjing, 210009, China

Location

MeSH Terms

Conditions

Shock; Sepsis

Interventions

Propofol

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Infections; Systemic Inflammatory Response Syndrome; Inflammation

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Tao Yu

  Nanjing Zhong-Da Hospital, Southeast University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: clinical doctor

Study Record Dates

• First Submitted: October 5, 2011
• First Posted: October 6, 2011
• Study Start: May 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: January 29, 2014

Record last verified: 2012-05

Locations

CN (1)