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.: PACTR201710002685398 Date of Approval: 12/10/2017
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Dobutamine and Nitroglycerine versus Milrinone for Perioperative Management of Pulmonary Hypertension in Mitral Valve Surgery
Official scientific title Dobutamine and Nitroglycerine versus Milrinone for Perioperative Management of Pulmonary Hypertension in Mitral Valve Surgery
Brief summary describing the background and objectives of the trial Background Pulmonary hypertension represents an important cause of morbidity and mortality in patients with mitral stenosis who undergo cardiac surgery. The aim of the study is to compare the effects of dobutamine and nitroglycerin or milrinone in patients with severe pulmonary hypertension undergoing mitral valve replacement. Patients and methods Forty patients had PAP > 50 mmHg scheduled for elective mitral valve replacement. The patients were randomly divided into two equal groups according to the drugs given during weaning from CPB: Group I (Dobutamine & Nitroglycerin group) the patients received dobutamine 5-20 µg / kg/ min and nitroglycerine 0.5-3 µg / kg/ min and Group II (Milrinone group) the patients received milrione loading dose of 50 µg/kg over 10 min followed by a maintenance dose of 0.25- 0.75 µg/kg /min. Parameters of systemic and pulmonary hemodynamic were measured during weaning from cardiopulmonary bypass till 1st 12hs intensive care unit stay. Results There was significant decrease in mean pulmonary artery pressure, pulmonary capillary wedge pressure and central venous pressure in group II than group I at all time points after cardiopulmonary bypass. Significant increased in heart rate, mean arterial pressure, cardiac output and mixed venous oxygen tension in group I than group II which become more obvious by time. In both group there was significant decreased in systemic vascular resistance and pulmonary vascular resistance at all times. Conclusion Milrinone provide adequate cardiac performance causing a greater reduction in pulmonary artery pressure and pulmonary capillary wedge pressure.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,anesthesia,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 02/05/2015
Actual trial start date 16/05/2015
Anticipated date of last follow up 14/05/2017
Actual Last follow-up date 14/05/2017
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants) 40
Recruitment status Stopped early/ terminated
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 using a radomisation table created by a computer software program Sealed opaque envelopes 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 doputamine & nitroglycerine doputamine5-20 mic/kg/min&nitroglycerine 0.5-3mic/kg/min intraoperative&12 hr in icu group I 20
Experimental Group milrinone loading dose 50 mic/kg over 10 min followed by 0.25-0.75 mic/kg/min intraoperative&12 hr in icu group II 20
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
The inclusion criteria were patients with mitral valve disease aged between 22 to 45 years old of both sexes having PAP ranged from 65 to 110 mmHg and scheduled for elective mitral valve replacement. The Exclusion criteria were patients with Severely reduced myocardial function i.e. left ventricular ejection fraction <45%, Severe liver insufficiency, Renal insufficiency (serum creatinine >2.0 mmol/L), Severe chest disease or COPD patients, Pulmonary valve disease or replacement, Recent pacemaker insertion, left bundle branch block, Wolf Parkinson-White Syndrome or Ebstein¿s anomaly and Recent stroke. 22 Year(s) 45 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 05/04/2015 anesthesia department ethical comitte
Ethics Committee Address
Street address City Postal code Country
3, yassin abdelghafar shibin elkoom 1234 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome mean pulmonary artery pressure Baseline (after induction of anesthesia), before cardiopulmonary bypass, after coming off bypass and starting the drug infusions, before patient transfer to ICU and every 4 hours in ICU for 12 hours.
Secondary Outcome hemodynamic parameters(heart rate&blood pressure) Baseline (after induction of anesthesia), before cardiopulmonary bypass, after coming off bypass and starting the drug infusions, before patient transfer to ICU and every 4 hours in ICU for 12 hours.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
menofiya university hospital 3,yassin abdelghafar shibin elkoom 1234 Egypt
national heart institute kornish street,imbaba cairo 2345 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
menoufiya faculty of medicine 3,yassin abdelghafar shibin elkoom Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor menoufiya faculty of medicine 3,yassin abdelghafar shibin elkoom Egypt University
COLLABORATORS
Name Street address City Postal code Country
ahmed abd elraouf 3,yassin abdelghafar shibin elkoom Egypt
montasser abo elkasem 3,yassin abdelghafar shibin elkoom Egypt
ashraf elmeligy 3,yassin abdelghafar shibin elkoom Egypt
lamiaa hussein 3,yassin abdelghafar cairo Egypt
ashraf eskandr 3,yassin abdelghafar shibin elkoom Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator lamiaa hussein ameskandr@yahoo.com 0020482570018 kornish street, imbaba
City Postal code Country Position/Affiliation
cairo Egypt specialist of anesthesia,national heart institute
Role Name Email Phone Street address
Public Enquiries ahmed abd elraouf ahmedabdelraoufmetwally@yahoo.com 00201227968325 3, yassin abdelghafar
City Postal code Country Position/Affiliation
shibin elkoom Egypt professor of anesthesia, menoufiya faculty of medicine
Role Name Email Phone Street address
Scientific Enquiries ashraf eskandr ameskandr@yahoo.com 00201001960697 3, yassin abdelghafar
City Postal code Country Position/Affiliation
shibin elkoom Egypt associate professor of anesthesia, menoufiya faculty of medicine
REPORTING
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