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.: PACTR201510001274643 Date of Approval: 20/09/2015
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Clinical effect of lowering heart rate in sepsis syndromes; comparing ivabradine 10 mg and 15 mg versus placebo.
Official scientific title Clinical effect of lowering heart rate in sepsis syndromes; comparing ivabradine 10 mg and 15 mg versus placebo.
Brief summary describing the background and objectives of the trial Ivabradine is an If current inhibitor at the SA node. It is shown to have heart rate lowering effect with the simultaneous ability to avoid negative effects on contractility or conductivity; that is to say a pure heart rate lowering effect.Ivabradine preferentially hinders the pacemaker If current in a dose dependent behavior at concentrations that do not influence other myocardial ion currents. It slows the heart rate by changing the slope of diastolic depolarization, so more time is permitted for the blood to flow in the coronaries during the diastolic phase of the cardiac cycle, this in turn increases the oxygen supply and reduces the myocardial oxygen requirements. furthermore, ivabradine has no effect on sympathetic pathways and subsequently no interference with inotropic amines
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Circulatory System,sepsis syndromes
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Supportive care
Anticipated trial start date 01/10/2015
Actual trial start date
Anticipated date of last follow up 01/06/2016
Actual Last follow-up date
Anticipated target sample size (number of participants) 90
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
ANACA20/8/2015 Faculty of medicine , Cairo univ.
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
Parallel: different groups receive different interventions at same time during study Randomised computer generated random number in sealed opaque envelops into one of three groups, 30 patients each Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Ivabradine 5 mg twice daily via an enteral route 10 mg 6 days ivabradine 10 mg 30
Experimental Group Ivabradine 7.5 mg twice daily via an enteral route 15 mg 6 days ivabradine 15 mg 30
Control Group placebo twice daily via an enteral route 6 days placebo 30 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
-severe sepsis, septic shock or Multiple organ dysfunction syndrome -Sinus rhythm with heart rate ¿ 90bpm refusal by the patient or the responsible guardian ¿ Patients younger than 18 years of age ¿ Hypersensitivity to the active substance or any of the excipients ¿ Pregnancy, lactation ¿ Patients with a history of pre-existing chronic renal failure with a glomerular filtration rate <30ml/min ¿ Patients with malignant hyperthermia or burn patients ¿ Patients with acute rejection after organ transplantation ¿ Patients who have participated or participate in other studies within the last 3 months ¿ Other types of shock than septic or cardiogenic shock ¿ Patients with severe valvular heart disease ¿ Severe hepatic insufficiency ¿ Sick sinus syndrome ¿ pacemaker-dependency ¿ 3rd degree AV block ¿ Use of potent cytochrome P450 3A4 inhibitors such as antifungals of the azole -type (ketoconazole, itraconazole), macrolide antibiotics (clarithromycin, erythromycin) 18 Year(s) 99 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 20/08/2015 ethical comittee, anesthesia and ICU departement , faculty of medicine , Cairo univ.
Ethics Committee Address
Street address City Postal code Country
cairo Egypt
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 20/08/2015 ethical comittee, anesthesia and ICU departement , faculty of medicine , Cairo univ.
Ethics Committee Address
Street address City Postal code Country
kasr Al Ainy street, Manial, Cairo, Egypt cairo Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome reduction in base line heart rate, during admission
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
anesthesia and ICU departement, faculty of medicine, Cairo university kasr Al Ainy street, Manial, Cairo, Egypt cairo 11559 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
faculty of medicine, cairo university hospital resources Cairo Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor anesthesia and ICU departement , faculty of medicine, Cairo univ kasr Al Ainy street, Manial, Cairo, Egypt cairo Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
mohamed mourad hashim 14th. nabil taha street, faisal cairo Egypt
Atef kamel salama anesthesia dapartement, faculty of medicine, kasr Al Ainy street, Manial, Cairo, Egypt cairo Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator mohamed hashim mourad50009@yahoo.com +201140662469 14th. nabil taha street, faisal
City Postal code Country Position/Affiliation
cairo Egypt leccturer
Role Name Email Phone Street address
Public Enquiries mohamed hashim mourad50009@yahoo.com +201140662469 14th. nabil taha street, faisal
City Postal code Country Position/Affiliation
cairo Egypt leccturer
Role Name Email Phone Street address
Scientific Enquiries mohamed hashim mourad50009@yahoo.com +201140662469 14th. nabil taha street, faisal
City Postal code Country Position/Affiliation
cairo Egypt leccturer
REPORTING
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Result URL Hyperlinks
Changes to trial information