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

NCT03151668 | Unknown Phase 3

• 1 other identifier: N-14 -2017
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Septic Shock

Outcome Measures

Primary Outcomes (1)

• Evaluation of microvascular flow index 6hours after dexmedetomidine infusion

  6 months

Secondary Outcomes (2)

• The effect of the dexmeditomidine on perfusion index

  6 months

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

  6 months

Study Arms (2)

Dexmedetomidin

EXPERIMENTAL

Drug: Dexmedetomidine

Midazolam

NO INTERVENTION

Interventions

Dexmedetomidine DRUG

Dexmedetomidin

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Unknown Facility

Cairo, 002, Egypt

RECRUITING

Related Publications (3)

• 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.

  PMID: 26529657 BACKGROUND

• 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.

  PMID: 25929655 BACKGROUND

• 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.

  PMID: 25313879 BACKGROUND

MeSH Terms

Conditions

Shock, Septic

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Islam R Abd el-fttah

CONTACT

+201002024166; Islam_rasmy158@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assisstant lecturer

Study Record Dates

• First Submitted: May 8, 2017
• First Posted: May 12, 2017
• Study Start: January 4, 2017
• Primary Completion: March 1, 2018
• Study Completion: April 1, 2018
• Last Updated: January 24, 2018

Record last verified: 2018-01

Locations

EG (1)