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.: PACTR201911806644230 Date of Approval: 11/11/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Ivabradine on renal function
Official scientific title Impact of Ivabradine on renal function in septic patient with early renal impairment
Brief summary describing the background and objectives of the trial The incidence of sepsis and renal impairment in critical patients is gradually increasing, and both of them indicate a poor prognosis and increases mortality (is a specific inhibitor of the If current in the Sino atrial node, reducing heart rate in patients in sinus rhythm) administration was effective in reducing microvascular derangements evoked by fluid-resuscitated sepsis in the hamster skinfold chamber microcirculation, which was accompanied by better tissue perfusion and less organ dysfunction.In our study we hypnotized that use of ivardrabine as heart rate reducing agent in septic patient with renal impairment may improve renal function
Type of trial RCT
Acronym (If the trial has an acronym then please provide) Ivabradine renal function
Disease(s) or condition(s) being studied Kidney Disease,sepesis and renal impariment
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 02/10/2019
Actual trial start date 08/10/2019
Anticipated date of last follow up 17/01/2020
Actual Last follow-up date 31/12/2019
Anticipated target sample size (number of participants) 200
Actual target sample size (number of participants) 50
Recruitment status Recruiting
Publication URL https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8276210/
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
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group received conventional treatment sepsis and placebo tablet twice per day for 3 days for 3 days received conventional treatment sepsis according to ain shames university hospitals protocol and placebo tablet 25 Placebo
Experimental Group received conventional treatment sepsis and Ivabradine tablet at 5 mg twice daily, and if tolerated can be safely continued to 7.5 mg twice daily. 3 days received conventional treatment sepsis according to ain shames university hospitals protocol and enteral preparation (orally, via nasogastric tube or Jejunum tube) of Ivabradine Procoralan® 5mg (Manufacturer:, Servie (Ireland) Industries Ltd Gorey Roa Arklow — Co. Wicklow Ireland) for 3 days The dosing is started at 5 mg twice daily, and if tolerated can be safely continued to 7.5 mg twice daily 25
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
age 18-60 years old arriving (ASUICU) diagnosed with sever sepsis ≤ 24 h according to Surviving Sepsis Campaign Guidelines Committee (3) with Sinus rhythm with heart rate ≥ 95 bpm( after adequate resuscitation) and early renal impairment defined by the RIFLE classification (9) (when increased plasma creatinine ×1.5 or GFR decrease >25% of normal range for age or urine output <0.5 ml/kg/h×6 h). patients with pre-existing renal or started renal dialysis, hypersensitivity to the drug, pregnancy, severe hepatic or cardiac insufficiency , Sick sinus syndrome, Sinu-atrial block pacemaker-dependency ,3rd degree AV block, Use antifungals of the azole -type (ketoconazole, itraconazole), macrolide antibiotics (clarithromycin). Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 60 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 20/10/2019 Ain shams university ethical committee FWA 000017585
Ethics Committee Address
Street address City Postal code Country
38 abassa cairo 11591 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome is to determine whether ivabardine could reduce heart rates to be less than the predefined threshold of 95/min with improvement of kidney function by 25% within 72 hours from the start of treatment. after 3 days
Secondary Outcome is to assess prevention of dialysis, vasopressor dosage consumption, ICU hospital stay and mortality. 28 days
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
ain shams university hospital 38 abassia-cairo- egypt cairo 11591 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
amr sobhy 13 elmakwleen elarab cairo 11771 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor amr sobhy elmakwleen elarab-elnozha cairo Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
aktham adel shoukary 5 elrahab cairo 11841 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator amr sobhy dr.amrsobhy2013@gmail.com 00201063394383 13 elmakwleen
City Postal code Country Position/Affiliation
cairo 11771 Egypt Ain shams university faculty of medicine department of anesthesia I.C.U and pain management
Role Name Email Phone Street address
Public Enquiries AKTHAM ADEL aktham.shoukry1@gmail.com 00201009506027 ELREHAB
City Postal code Country Position/Affiliation
CAIRO 11841 Egypt AIN shams university faculty of medicine department of anesthesia I.C.U and pain management
Role Name Email Phone Street address
Scientific Enquiries amr sobhy dr.amrsobhy2013@gmail.com 00201063394383 elmakwleen elarab
City Postal code Country Position/Affiliation
cairo 11771 Egypt ain shams university faculty of medicine department of anesthesia I.C.U and pain management
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes informed consent Study Protocol within 2 month open
URL Results Available Results Summary Result Posting Date First Journal Publication Date
https://scholar.google.com/citations?user=vcn8u0sAAAAJ&hl=en 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