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

Primary Purpose

Septic Shock

Status

Unknown status

Phase

Phase 3

Locations

Egypt

Study Type

Interventional

Intervention

Dexmedetomidine

About this trial

This is an interventional treatment trial for Septic Shock

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Dexmedetomidin

Midazolam

Arm Description

Outcomes

Primary Outcome Measures

Evaluation of microvascular flow index 6hours after dexmedetomidine infusion

Secondary Outcome Measures

The effect of the dexmeditomidine on perfusion index

Correlation between perfusion index and microvascular flow index in septic shock patients

Full Information

NCT ID

NCT03151668

First Posted

May 8, 2017

Last Updated

January 23, 2018

Sponsor

Cairo University

1. Study Identification

Unique Protocol Identification Number

NCT03151668

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2018

Overall Recruitment Status

Unknown status

Study Start Date

January 4, 2017 (Actual)

Primary Completion Date

March 2018 (Anticipated)

Study Completion Date

April 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Cairo University

4. Oversight

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Septic Shock

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Dexmedetomidin

Arm Type

Experimental

Arm Title

Midazolam

Arm Type

No Intervention

Intervention Type

Drug

Intervention Name(s)

Dexmedetomidine

Primary Outcome Measure Information:

Title

Evaluation of microvascular flow index 6hours after dexmedetomidine infusion

Time Frame

6 months

Secondary Outcome Measure Information:

Title

The effect of the dexmeditomidine on perfusion index

Time Frame

6 months

Title

Correlation between perfusion index and microvascular flow index in septic shock patients

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Islam R Abd el-fttah

Phone

+201002024166

Islam_rasmy158@yahoo.com

Facility Information:

City

Cairo

ZIP/Postal Code

002

Country

Egypt

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Islam R Abd el-fttah

12. IPD Sharing Statement

Citations:

PubMed Identifier

26529657

Citation

Rasmy I, Mohamed H, Nabil N, Abdalah S, Hasanin A, Eladawy A, Ahmed M, Mukhtar A. Evaluation of Perfusion Index as a Predictor of Vasopressor Requirement in Patients with Severe Sepsis. Shock. 2015 Dec;44(6):554-9. doi: 10.1097/SHK.0000000000000481.

Results Reference

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PubMed Identifier

25929655

Citation

Zhang J, Wang Z, Wang Y, Zhou G, Li H. The effect of dexmedetomidine on inflammatory response of septic rats. BMC Anesthesiol. 2015 May 1;15:68. doi: 10.1186/s12871-015-0042-8.

Results Reference

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PubMed Identifier

25313879

Citation

Miranda ML, Balarini MM, Bouskela E. Dexmedetomidine attenuates the microcirculatory derangements evoked by experimental sepsis. Anesthesiology. 2015 Mar;122(3):619-30. doi: 10.1097/ALN.0000000000000491.

Results Reference

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

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