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

Septic Shock Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03151668
• Other study ID #: N-14 -2017
• Status: Recruiting
• Phase: Phase 3
• First received: May 8, 2017
• Last updated: January 23, 2018
• Start date: January 4, 2017
• Est. completion date: April 2018

Study information

• Verified date: January 2018
• Source: Cairo University
• Contact: Islam R Abd el-fttah
• Phone: +201002024166
• Email: Islam_rasmy158[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: April 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Sepsis
• Septic Shock
• Shock
• Shock, Septic

Intervention

Drug:
• Dexmedetomidine

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of microvascular flow index 6hours after dexmedetomidine infusion		6 months
Secondary	The effect of the dexmeditomidine on perfusion index		6 months
Secondary	Correlation between perfusion index and microvascular flow index in septic shock patients		6 months