The Effect of Midazolam on Fluid Responsiveness in Septic Patients

January 30, 2014 updated by: Jianfeng Xie, Southeast University, China
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, (86)210009
        • Department of Critical Care , Zhong-da Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Patients are included if they meet the following inclusion criteria:

  1. Above 18 years old
  2. Endotracheal intubated and mechanical ventilated
  3. Awake, can communicate with researchers
  4. Diagnosed as septic shock. The definition of septic shock was clarified in Year 2001 ACCP/SCCM guidelines
  5. Within 24 hours after the EGDT resuscitation goals are achieved
  6. Informed consent are signed.

Exclusion Criteria

  1. Under 18 years old
  2. Intra-abdominal hypertension
  3. Central nerves system dysfunction
  4. Heart failure and other cardiac dysfunction such as cardiac conduction block,acute coronary syndrome, cardiogenic shock
  5. Proof of volume overload or contradiction of fluid infusion
  6. Existence of arterial aneurysm, serious valvular disease,extensive peripheral vascular occlusion disease and insertion of artificial pacemaker

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Midazolam
Midazolam infused at a 0.03mg/kg loading dose ,and 0.02-0.1mg/kg.h maintenance dose to achieve Ramsay score of 4
Drug: sedatives(Midazolam and Propofol)
Experimental: Propofol
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
Drug: sedatives(Midazolam and Propofol)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
percentage of participants with more than 10% increase of cardiac index by passive leg raising after sedation
Time Frame: Baseline,after sedation
Baseline,after sedation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Southeast University, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (Actual)

April 1, 2013

Study Completion (Actual)

April 1, 2013

Study Registration Dates

First Submitted

March 5, 2013

First Submitted That Met QC Criteria

January 30, 2014

First Posted (Estimate)

January 31, 2014

Study Record Updates

Last Update Posted (Estimate)

January 31, 2014

Last Update Submitted That Met QC Criteria

January 30, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • fluid responsiveness

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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