Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202112845314910 Date of Approval: 01/12/2021
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of Dexmedetomidine vs Midazolam on the microcirculation of septic patients who are mechanically ventilated
Official scientific title Effect of Dexmedetomidine vs Midazolam on the microcirculation of septic patients who are mechanically ventilated
Brief summary describing the background and objectives of the trial Sepsis affects all elements at the microcirculatory level. It is associated with a decrease in capillary density and increase in heterogenousity of perfusion caused by inappropriate vasodilatation and vasoconstriction, leading to decreased oxygen delivery, tissue hypoxia and organ dysfunction . Dexmedetomidine is generally preferable as a sedative in many cases in ICU. Moreover, expression of possible beneficial effects of dexmedetomidine on microcirculation in septic patients would make the drug an obvious better choice in sepsis, not only for it’s known lighter sedative, and less agitative effects, but also for it’s direct positive outcome in sepsis.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Circulatory System,Infections and Infestations
Sub-Disease(s) or condition(s) being studied sepsis
Purpose of the trial Treatment: Drugs
Anticipated trial start date 16/02/2020
Actual trial start date
Anticipated date of last follow up 16/02/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 128
Actual target sample size (number of participants) 128
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group dexmedetomidine infusion dexmedetomidine infusion will be 0.2 to 0.7 mcg/kg/hr as required according to the sedation needs, and hemodynamics of the patient. 24 hours The used sedative is dexmedetomidine infusion for patients having sepsis and requiring sedation for mechanical ventilation. Sepsis is defined according to the third international consensus definitions for sepsis and septic shock (sepsis-3), patients are treated following survival sepsis campaign recommendations.Microcirculation will be assessed, where Perfusion index as a non-invasive parameter for direct assessment of the microcirculatory will be measured, and compared in the two groups (intervention and control)using Masimo device .The timing for taking measurements in both groups will be just before administration of sedation (t0), at two hour (t2), at four hours (t4), at six (t6) and twenty four hours (t24). Indirect assessment of the microcirculation in both groups (intervention and control)will be done through global markers of perfusion as P(v-a)Co2, ScVO2, and Mean Arterial Pressure (MAP).The timing of taking the results will be just before administration (t0), at 12 hours t(12), and at 24 hours (t24). 64
Control Group midazolam infusion midazolam infusion will be 0.06 to 0.12 mg /kg/hr as required according to the sedation needs, and hemodynamics of the patient. 24 hrs The used sedative is midazolam infusion for patients having sepsis and requiring sedation for mechanical ventilation. Sepsis is defined according to the third international consensus definitions for sepsis and septic shock (sepsis-3), patients are treated following survival sepsis campaign recommendations.Microcirculation will be assessed, where Perfusion index as a non-invasive parameter for direct assessment of the microcirculatory will be measured, and compared in the two groups (intervention and control)using Masimo device .The timing for taking measurements in both groups will be just before administration of sedation (t0), at two hour (t2), at four hours (t4), at six (t6) and twenty four hours (t24). Indirect assessment of the microcirculation in both groups (intervention and control)will be done through global markers of perfusion as P(v-a)Co2, ScVO2, and Mean Arterial Pressure (MAP).The timing of taking the results will be just before administration (t0), at 12 hours t(12), and at 24 hours (t24). 64 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Both males and females • Age more than 21 years old • Patients having sepsis requiring sedation for mechanical ventilation, according to the third international consensus definitions for sepsis and septic shock (sepsis-3). Pregnant or breast-feeding women • Age < 21 years old • Allergy to any of the drugs used in the study • 2nd or 3rd degree Heart block • Systolic blood pressure < 90 • Patient with EF < 30% example (Heart failure, MI) • HR < 50 bpm • Child B or C cirrhotic liver disease • Documented Acute coronary syndromes • Presence of Intra-cardiac shunts • The need to use positive inotropic drugs for circulatory support 80 and over: 80+ Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 21 Year(s) 100 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 16/02/2020 Research Ethics Committee at Faculty of medicine Ain Shams university
Ethics Committee Address
Street address City Postal code Country
Ramsis street, Abbassia square Cairo 11591 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The effect of Dexmedetomidine on the microcirculation in sepsis, by direct assessment through perfusion index. 0hr , 2hr, 4hr, 6hr ,24hr.
Secondary Outcome Indirect assessment of the microcirculation in both groups will be done through global markers of perfusion as P(v-a)Co2, ScVO2, and Mean Arterial Pressure (MAP). 0hrs ,12hrs , 24 hrs
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Faculty of medicine at Ain Shams University Ramsis street, Abbassia square cairo 11591 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Mostafa Mohamed Atef Mohamed Refaat new cairo 5th settelment miveda parcel10 6A cairo Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Mostafa Mohamed Atef Mohamed Miveda 5th settelment Cairo 11835 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mostafa Mohamed Atef Mohamed Refaat drmostafarefaat@outlook.com 00201100110033 Miveda parcel 10 6A fifth settelment
City Postal code Country Position/Affiliation
Cairo 11835 Egypt Assistant lecturer of Anesthesiology and intensive care at faculty of medicine
Role Name Email Phone Street address
Public Enquiries Osama Mansour viced.research@med.asu.edu.eg +20224346344 Ramsis street
City Postal code Country Position/Affiliation
Cairo Egypt Vice Dean of research committee at faculty of medicine
Role Name Email Phone Street address
Scientific Enquiries Amr Foad amrfouad85@gmail.com 01225674370 Fifth settelment
City Postal code Country Position/Affiliation
Cairo Egypt Lecturer of anesthesiology and intensive care at faculty of medicine
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data will be available. Study Protocol Not applicable Not applicable
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information