Effect of Dexmedetomidine on Perfusion Index and Microcirculation in Severe Sepsis and Septic Shock Patients

January 23, 2018 updated by: Islam Rasmy, Cairo University

The Effect of Dexmedetomidine on Perfusion Index and Microcirculation in Patients With Severe Sepsis and Septic Shock: Randomized Controlled Study

Septic shock is one of the major causes of death worldwide with in-hospital mortality rates varying between (11.9% to 47.2 %). Alterations in microcirculatory blood flow were associated with high risk of organ dysfunction and death. Experimental studies on septic rats revealed that dexmedetomidine treatment can effectively reduce the generation of inflammatory mediators and yields beneficial effects on endotoxemic animals' microcirculation.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Prospective randomized double blinded study. Investigators planned to enroll (40 cases diagnosed with severe sepsis and/or septic shock ) admitted in 50-bed trauma and surgical ICU Cairo University hospital. Demographic data, cause of ICU admission, source of sepsis, APACHE II score, SOFA score 24 hours after admission. Microcirculatory variables (MFI), peripheral perfusion (PI) and metabolic variables will be measured before drugs administrations and at 2, 4, 6, 24 hours thereafter. The total dose of the infused drugs, The requirement of vasopressor will be evaluated as yes/no and total dose of vasopressor will be calculated.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 3

Contacts and Locations

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

Study Contact

Study Locations

  • Egypt
      • Cairo, Egypt, 002
        • Recruiting
        • Contact:
          • Islam R Abd el-fttah

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

Inclusion Criteria:

  • Age more than 18 years old
  • All mechanically ventilated patients who will be clinically suspected of having severe sepsis/septic shock defined by the criteria of the American College of Chest Physicians/ Society of Critical Care Medicine Consensus Conference

Exclusion Criteria:

  • Age < 18 years old
  • Pregnant patient
  • Acute hepatitis or severe liver disease (Child-Pugh class C)
  • Left ventricular ejection fraction less than 30%
  • Heart rate less than 50 beats/min
  • Second or third degree heart block
  • Systolic pressure < 90 mmHg despite of infusion of 2 vasopressors

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dexmedetomidin
Drug: Dexmedetomidine
No Intervention: Midazolam

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evaluation of microvascular flow index 6hours after dexmedetomidine infusion
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
The effect of the dexmeditomidine on perfusion index
Time Frame: 6 months
6 months
Correlation between perfusion index and microvascular flow index in septic shock patients
Time Frame: 6 months
6 months

Collaborators and Investigators

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

Sponsor

Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

January 4, 2017

Primary Completion (Anticipated)

March 1, 2018

Study Completion (Anticipated)

April 1, 2018

Study Registration Dates

First Submitted

May 8, 2017

First Submitted That Met QC Criteria

May 11, 2017

First Posted (Actual)

May 12, 2017

Study Record Updates

Last Update Posted (Actual)

January 24, 2018

Last Update Submitted That Met QC Criteria

January 23, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N-14 -2017

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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