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.: PACTR202306748777678 Date of Approval: 27/06/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title midodreine in cirrhotic patients with refractory ascites
Official scientific title The effects of Midodrine on patients with liver cirrhosis and refractory ascites
Brief summary describing the background and objectives of the trial splanchnic vasodilatation is a major contributor to development of ascites in cirrhotic patients due to circulatory vasodilators with decreased systemic blood pressure and decreased renal blood flow , hence activation of renin angiotensin system and anti diuretic hormon with salt and water retention MIDODRINE which is, alpha 1 agonist, produces vasoconstriction leading to increase mean arterial blood pressure,increase renal blood flow and eGFR hence increasing naturetic response to Diuretics the addition of midodrine to standard treatment of ascites ( salt restriction , diuretics and large volume paracentesis) in a dose of 7.5 gm /8 hours daily for one month ameliorate ascites in refractory patients estimated by reduction of body weight and abdominal girth in addition to increase urine out put and sodium excretion
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Digestive System
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/03/2021
Actual trial start date 30/04/2021
Anticipated date of last follow up 28/02/2022
Actual Last follow-up date 31/03/2022
Anticipated target sample size (number of participants) 80
Actual target sample size (number of participants) 80
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table created by a computer software program Numbered containers Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group midodrine 2.5 mg and SMT 3 tablets every 8 hours one month Midodrine group patients have to receive midodrine (7.5mg /8hrs) for one month. 40
Control Group Standard medical treatment one month Traditional treatment included salt restriction to less than 90 mmol/day and diuretics spironolactone up to 400 mg /day and furosemide up to 160 mg /day or as tolerated provided that no complications as hepatic encephalopathy, hypokalemia, hyponatremia, impaired renal functions had occurred. Plus, large volume paracentesis 40 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
-Cirrhotic patients more than 18 years • Cirrhosis secondary to any etiology. • Cirrhosis was diagnosed by US evaluation. 2-Patients with refractory ascites. The willing to sign informed consent and ready for regular follow-up during the study. • Patients with acute or chronic renal disease. • Patients with cardiac disease: 1-Coronary heart disease. 2-Abnormal blood pressure. 3-Congestive heart failure. • Hepatocellular carcinoma. • Portal vein thrombosis. 80 and over: 80+ Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 80 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 09/02/2021 research ethics committee
Ethics Committee Address
Street address City Postal code Country
elgiesh street Tanta 31527 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary outcome of the study is to assess the effect of midodrine on body weight, abdominal girth and urine volume. after one month
Secondary Outcome to assess the safety of midodrine as a treatment for refractory ascites. after one month
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Tanta university hospital Elgeish street Tanta 040 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
the researcher tanta Tanta 040 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor tanta university hospital tanta tanta 250 Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator essam aboelnasr essamaboelnasr@gmail.com 01110317093 kafr elzayat
City Postal code Country Position/Affiliation
kafr elzayat 040 Egypt demonstrator
Role Name Email Phone Street address
Public Enquiries mohamed gamal essamaboelnasr1993@gmail.com 011110317093 kz
City Postal code Country Position/Affiliation
kz 040 Egypt Hr
Role Name Email Phone Street address
Scientific Enquiries samah mosaad essamaboelnasr@gmail.com 01110317093 tanta
City Postal code Country Position/Affiliation
tanta 040 Egypt professor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All individual collected data will be available after deidentification Statistical Analysis Plan,Study Protocol Immediately after publication With no end date Researchers who provide methodologically sound proposal To achieve the aim of the proposal
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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