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.: PACTR201705002221230 Date of Approval: 21/04/2017
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Terlipressin Infusion for Management of Post-CABG Refractory Hypotension: A Comparative Study versus Nor-epinephrine Infusion
Official scientific title Terlipressin Infusion for Management of Post-CABG Refractory Hypotension: A Comparative Study versus Nor-epinephrine Infusion
Brief summary describing the background and objectives of the trial This study is designed to compare terlipressin infusion to the standard vasopressor agent (norepinephrine infusion) for the treatment of refractory hypotension after cardiopulmonary bypass in diabetic patients undergoing coronary artery bypass grafting and to evaluate the outcome of these patients.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Circulatory System,refractory hypotension after cardiopulmonary bypass in diabetic patients,Respiratory,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial terlipressin infusion
Anticipated trial start date 01/03/2017
Actual trial start date 01/03/2017
Anticipated date of last follow up 31/03/2017
Actual Last follow-up date
Anticipated target sample size (number of participants) 44
Actual target sample size (number of participants) 44
Recruitment status Recruiting
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 simple randomisation Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group noradrenaline infusion 0.1 ¿g/kg/min 4 hours noradrenaline infusion 22 Active-Treatment of Control Group
Experimental Group Terlipressin infusion 2 ug/kg/hr 4 hours Terlipressin infusion 22
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Diabetic patients Undergoing elective CABG surgery using CPB Normal ventricular function Experience refractory hypotension after CPB Emergency cardiopulmonary bypass Pripheral vascular disease Hepatic or Kidney dysfunction preoperative unstable conditions such as severe arrhythmia, heart failure or cardiogenic shock 20 Year(s) 70 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 28/02/2017 FM-BSU REC
Ethics Committee Address
Street address City Postal code Country
Shamla street Beni Suef 12411 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome correction of hypotension to achieve SAP>90 mmHg and/or MAP>60 mmHg. 10 minutes after start of infusion 30 minutes after start of infusion 4 hours after start of infusion
Secondary Outcome Blood glucose levels 4 hours after infusion start 8 hours after infusion start 12 hours after infusion start
Secondary Outcome Evaluation of Cardiac ischemia markers (serum CK-MB and cTT) 12 hours after infusion start 24 hours after infusion start
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Beni Suef University hospital Shamla street Beni Suef 12411 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
personal 7 Ali Ebn Abi Taleb st Cairo 11311 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Ahmed Mostafa El-Shaarawy 7 Ali Ebn Abi Taleb st Cairo 11311 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Hisham Mohamed Elbatanony Hosary street Cairo 11311 Egypt
Ahmed Mostafa El-Shaarawy Ali Ebn Abi Taleb st Cairo 11311 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ahmed El-Shaarawy drshaarawy@gmail.com 00201141015584 7 Ali Ebn Abi Taleb st
City Postal code Country Position/Affiliation
Cairo 11311 Egypt lecturer of Anesthesia, Beni Suef University
Role Name Email Phone Street address
Public Enquiries Ahmed El-Shaarawy drshaarawy@gmail.com 00201141015584 7 Ali Ebn Abi Taleb st
City Postal code Country Position/Affiliation
Cairo 11311 Egypt lecturer of Anesthesia, Beni Suef University
Role Name Email Phone Street address
Scientific Enquiries Ahmed El-Shaarawy drshaarawy@gmail.com 00201141015584 7 Ali Ebn Abi Taleb st
City Postal code Country Position/Affiliation
Cairo 11311 Egypt lecturer of Anesthesia, Beni Suef University
REPORTING
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information