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.: PACTR201507000984471 Date of Approval: 28/12/2014
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Cardiac and renal protective effects of dexmedetomidine in cardiac surgeries
Official scientific title Cardiac and renal protective effects of dexmedetomidine in cardiac surgeries
Brief summary describing the background and objectives of the trial Dexmedetomidine has been shown to protect several organs against ischemia-reperfusion (I/R) induced injury. We performed a randomized controlled trial to assess cardiac and renal protective effects of dexmedetomidine in patients undergoing cardiac surgeries.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Cardiac and renal protective,Circulatory System
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Diagnosis / Prognosis
Anticipated trial start date 11/06/2012
Actual trial start date 11/06/2012
Anticipated date of last follow up 07/01/2014
Actual Last follow-up date 17/02/2014
Anticipated target sample size (number of participants) 50
Actual target sample size (number of participants) 50
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
Parallel: different groups receive different interventions at same time during study Randomised Randomization done through using a random number table generated by Microsoft Excel. An independent statistician will be assigned to perform central randomization to ensure proper concealment of the study management from the patients and investigators until the release of the final statistical results. An independent statistician was assigned to perform central randomization to ensure proper concealment of the study management from the patients and investigators until the release of the final statistical results. Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group dexmedetomidine 1 µg kg-1 for 15 minutes, followed by 0.5 µg kg -1 h-1) until 6 h after surgery initiated 5 minutes before cardiopulmonary bypass until 6 h after surgery a continuous infusion of dexmedetomidine initiated 5 minutes before cardiopulmonary bypass (1 µg kg-1 for 15 minutes, followed by 0.5 µg kg -1 h-1) until 6 h after surgery 30
Control Group placebo control group will receive an equivalent volume of physiological saline initiated 5 minutes before cardiopulmonary bypass until 6 h after surgery control group will receive an equivalent volume of physiological saline 30 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
ASA class II or III patients scheduled for cardiac surgery by using CPB age > 75 years, left ventricular ejection fraction (LVEF) < 55%, pre-existing severe LV hypertrophy, cardiomyopathies, grade II (pseudo-normal filling) and grade III (restrictive filling) diastolic dysfunction, preoperative atrial fibrillation , pericardial disease, drug dependence, cerebrovascular diseases, use of alpha 2 agonists ,type 1diabetes mellitus, renal disease, significant pulmonary disease and hepatic insufficiency. 32 Year(s) 75 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 05/12/2012 Minoufiya faculty of medicine
Ethics Committee Address
Street address City Postal code Country
2 Yaseen Abdel-Ghaffar st., Shebin Elkoam 32511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome myocardial specific protein (troponin-I, creatine phosphokinase-MB "CPK MB") and urinary specific kidney proteins (N- acetyl ¿beta- D glucosamidase, alpha-1-microglobulin, glutathione transferase- pi, glutathione transferase- alpha ). Serum pro-inflammatory cytokines (tumor necrosis factor-¿ and interleukin 1-¿) and norepinephrine and cortisol levels. They were measured within 5 min of starting anesthesia as a base line (T0), at the end of surgery (T1), 12h after surgery (T2), 24h after surgery (T3), 36 h postoperatively (T4) and 48 h postoperatively (T5).
Primary Outcome creatinine clearance and serum cystatin measured before starting surgery as a baseline and at days 1, 4, 7 after surgery.
Secondary Outcome duration of mechanical ventilation, ICU stay time, hospital stay time, major postoperative complications and 30 day mortality. duration of mechanical ventilation, ICU stay time, hospital stay time, major postoperative complications and 30 day mortality.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Minoufiya University hospital 2 Yaseen Abdel-Ghaffar st., Shebin Elkoam 32511 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Minoufiya university 2 Yaseen Abdel-Ghaffar st., Shebin Elkoam 32511 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Minoufiya university 2 Yaseen Abdel-Ghaffar st., Shebin Elkoam 32511 Egypt University
COLLABORATORS
Name Street address City Postal code Country
khaled mahmoud 2 Yaseen Abdel-Ghaffar st., Shebin Elkoam 32511 Egypt
amany ammar 2 Yaseen Abdel-Ghaffar st., Shebin Elkoam 32511 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator khaled mahmoud mahmoudk16@yahoo.com +201223436409 2 Yaseen Abdel-Ghaffar st.,
City Postal code Country Position/Affiliation
Shebin Elkoam 32511 Egypt Professor in anesthesiology- Minoufiya faculty of medicine
Role Name Email Phone Street address
Public Enquiries khaled mahmoud mahmoudk16@yahoo.com +201223436409 2 Yaseen Abdel-Ghaffar st.,
City Postal code Country Position/Affiliation
Shebin Elkoam 32511 Egypt Professor in anesthesiology- Minoufiya faculty of medicine
Role Name Email Phone Street address
Scientific Enquiries khaled mahmoud mahmoudk16@yahoo.com +201223436409 2 Yaseen Abdel-Ghaffar st.,
City Postal code Country Position/Affiliation
Shebin Elkoam 32511 Egypt Professor in anesthesiology- Minoufiya faculty of medicine
REPORTING
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information