Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
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Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201704002184280 Date of Approval: 07/04/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Terlipressin in Cirrhotic Liver Patients For Early Detection Of Acute Kidney Injury Guided By Plasma NGAL Marker
Official scientific title Evaluating The Role Of Terlipressin In Cirrhotic Liver Patients for Early Detection Of Acute Kidney Injury Guided By Plasma Neutrophil Gelatinase-Associated Lipocalin (NGAL) Marker: Prospective randomized study
Brief summary describing the background and objectives of the trial Terlipressin (synthetic vasopressin analogue) was proved to improve renal blood flow. It exerts its action through activation of vasopressin receptors 1 (V1). It has been used in the treatment of hepatorenal syndrome (HRS). Terlipressin alters arterial blood volume from the splanchnic area and reduces the activity of the renin-angiotensin system, so it has a protective effect on kidneys during major hepatobiliary abdominal surgery. Neutrophil gelatinase-associated lipocalin (NGAL) is synthesized in kidney, liver and lung tissues. Plasma NGAL levels are used as a recent marker for predicting kidney injury. It has a controversy effects. However, limited data about the role of NGAL in hepatic patients pushing this study to investigate the role of plasma NGAL in timing treatment of these patients with terlipressin and follow up its effects on patient¿s outcome. The aim of this work is to assess the role of terlipressin therapy as a prophylactic measure of renal dysfunction in decompensated cirrhotic patients guided by measuring plasma NGAL, and to assess the impact of terlipressin on the improvement of MELD score in 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,Liver cirrhosis
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 15/04/2017
Actual trial start date 15/04/2017
Anticipated date of last follow up 31/10/2017
Actual Last follow-up date 31/10/2017
Anticipated target sample size (number of participants) 50
Actual target sample size (number of participants) 50
Recruitment status Not yet 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
Randomised Permuted block randomization (variable block size) Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Serum NGAL Blood sample withdrawal before and after 24 hr drug administration Blood sample withdrawal 25
Experimental Group Terlipressin 1 mg +50 ml 5% dextrose 24hr infusion rate of 8 ml/hr 25
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- Circulatory dysfunction due to bacterial infection. - hypovolemia secondary to gastrointestinal bleeding, paracentesis or diuretic use. - History of coronary artery disease - Cardiac arrhythmias - Cardiomyopathies - Obliterative arterial disease of the lower limbs - Asthma - Chronic obstructive pulmonary disease - Cerebrovascular disease 30 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 15/03/2017 IRB, Faculty of Medicine, Menoufiya University
Ethics Committee Address
Street address City Postal code Country
Yassin abd elghafar street Shebeen El.koom 32521 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Early detection of renal dysfunction after 24 hr drug administration
Secondary Outcome Plasma NGAL level Withdrawal serum NGAL on admission and after 24 hr after start glypressin infusion
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
The memorial Souad kafafi university hospital El-Mehwar El-Markazy, El-Motamayez District 6th of october city 12585 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
The memorial Souad kafafi university hospital El-Mehwar El-Markazy, El-Motamayez District 6th of october city 12585 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor The memorial Souad kafafi university hospital El-Mehwar El-Markazy, El-Motamayez District 6th of october city 12585 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Fawzia Mohamed Aboul Fetouh Cario University Street Giza 12613 Egypt
Khaled Ahmed Yassen Gamal AbdelNasser Street Shebeen Elkoom 32511 Egypt
Nagwa Mohamed Doha Gamal AbdelNasser Street Shebeen Elkoom 32511 Egypt
Naglaa Mostafa Hussien Gamal AbdelNasser Street Shebeen Elkoom 32511 Egypt
Ahmed Mohamed Kamal Zahra El-Mehwar El-Markazy, El-Motamayez District 6th of october city 12585 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Fawzia Aboul fetouh fawziafetouh@gmail.com 002-01222349556 Cairo University Street
City Postal code Country Position/Affiliation
Giza 12613 Egypt Professor of Anesthesia and Intensive Care, Faculty of Medicine, Cairo university
Role Name Email Phone Street address
Public Enquiries Elsayedamr Basma elsayedamr@yahoo.com 002-01223106023 30 Garden City Smouha
City Postal code Country Position/Affiliation
Alexandria 21646 Egypt Patient Information Manager
Role Name Email Phone Street address
Scientific Enquiries Khaled Yassen kyassen61@hotmail.com 002-01063080170 Gamal AbdelNasser Street
City Postal code Country Position/Affiliation
Shebeen Elkoom 32511 Egypt Professor of Anesthesia and Intensive Care, , National Liver Institute, Menoufiya University
REPORTING
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