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.: PACTR201405000798226 Date of Registration: 21/03/2014
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title The impact of paracentesis flow rate in patients with liver cirrhosis on the development of paracentesis induced circulatory dysfunction.
Official scientific title The impact of paracentesis flow rate in patients with liver cirrhosis on the development of paracentesis induced circulatory dysfunction.
Brief summary describing the background and objectives of the trial Ascites is a common dreadful complication of liver cirrhosis. It is associated with poor quality of life and short survival.[1-3] Therapeutic paracentesis can be used in patients with tense or refractory ascites.[4] Large volume paracentesis (LVP) of more than 5 L is associated with paracentesis induced circulatory dysfunction (PICD) development unless plasma expanders are given.[1, 5-7] If less than 5 L of ascites are tapped, usually PICD does not occur, and thereby artificial plasma expanders, saline, and albumin are equally effective.[8] PICD is characterized by reduction of effective arterial blood volume with subsequent activation of vasoconstrictor and anti-natriuretic factors. Clinically it provokes rapid ascites recurrence rate, development of dilutional hyponatremia, hepatorenal syndrome with increased mortality.[9] For preventing PICD development, albumin is given in a dose of 6-8 g/L ascites removed.[4-9] Since costly alternatives were studied like low dose albumin (2-4g/L),[10, 11] terlipressin,[11-15] noradrenaline,[15, 16] midodrine,[11, 17-19] synthetic colloids ,[11, 20-26] and saline. [27, 28] ¿-blockers should be avoided.[29, 30]. Does the paracentesis flow rate affect the development of PICD? This was the aim of the study.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) PICD
Disease(s) or condition(s) being studied Digestive System,liver cirrhosis
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Diagnosis / Prognosis
Anticipated trial start date 25/03/2014
Actual trial start date 21/05/2014
Anticipated date of last follow up 21/05/2014
Actual Last follow-up date 21/05/2014
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 60
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 using a randomisation table from a statistics book Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Group 1 Slow flow rate: low sodium flow rate 80ml per minute with 18 G Cannula 5 days Fixed volume 8L paracentesis under local anesthesia followed by albuni 2g per liter ascites removed 20
Experimental Group Group II medium flow rate flow rate 180ml per minute with 16 G Cannula 5 days Fixed volume 8L paracentesis under local anesthesia followed by albuni 2g per liter ascites removed 20
Experimental Group Group III: rapid flow rate flow rate 270ml per minute with 14 G Cannula 5 days Fixed volume 8L paracentesis under local anesthesia followed by albuni 2g per liter ascites removed 20
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1-the presence of tense ascites determined by clinical examination and abdominal ultrasound, requiring frequent therapeutic paracentesis 1-arterial hypertension, history of coronary disease, cardiac failure, respiratory disease. 2-hepatic encephalopathy. 3-sepsis 4-spontaneous bacterial peritonitis (defined by polymorphonuclear cell count >250/mm3 in ascites 5-elevated creatinine concentration >1.5 mg/dL 6-gastrointestinal bleeding within 7 days before the study. 18 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
No 01/04/2014 Menoufiya University National Liver Institute IRB
Ethics Committee Address
Street address City Postal code Country
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome paracentesis induced circulatory dysfunction (PICD) development Day 0 and 6
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
National Liver Institute, Menoufiya University Yassin Abdelghafar Shebeen El-Kom, Menoufiya 32511 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
National Liver Institute, Menoufiya University Yassin Abdelghafar Shebeen El-Kom, Menoufiya 32511 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor National Liver Institute, Menoufiya University Yassin Abdelghafar Shebeen El-Kom, Menoufiya 32511 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Ayman Alsebaey Alghoraieb National Liver Institute, Menoufiya Univ D Yassin Abdelghafar St, Shebben El-Kom, Menoufiya 32511 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ayman Alsebaey aymanalsebaey@yahoo.com +2/01003751248
City Postal code Country Position/Affiliation
Egypt Lecturer of Hepatology, National Liver Institute, Menoufiya University, Shebeen El-Kom, Egypt
Role Name Email Phone Street address
Principal Investigator Ayman Alsebaey aymanalsebaey@yahoo.com +2/01003751248 Nat LIver Institue, Menoufiya Univ, Dr Yassin Abdelghafar St
City Postal code Country Position/Affiliation
Shebeen El-Kom, Menoufiya 32511 Egypt Lecturer of Hepatology, National Liver Institute, Menoufiya University, Shebeen El-Kom, Egypt
Role Name Email Phone Street address
Public Enquiries Ayman Alsebaey Alghoraieb aymanalsebaey@yahoo.com +201003751248 Nat Liver Institute, Univ Manoufiya
City Postal code Country Position/Affiliation
Shebeen El-Kom 32511 Egypt Lecturer of Hepatology, National Liver Institute, Menoufiya University, Shebeen El-Kom, Egypt
Role Name Email Phone Street address
Scientific Enquiries Ayman Alsebaey Alghoraieb aymanalsebaey@yahoo.com +201003751248 Nat Liver Institute, Menoufiya Univ, Dr Yassin Abdelghafar street
City Postal code Country Position/Affiliation
Shebeen El-Kom, Menoufigy 32511 Egypt Lecturer of Hepatology, National Liver Institute, Menoufiya University, Shebeen El-Kom, Egypt
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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