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.: PACTR202001671840885 Date of Approval: 14/01/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Renal doppler and renal biomarker for prediction of acute kidney injury in patients with severe preeclampsia
Official scientific title Renal Resistance Indices and Neutrophil Gelatinase-Associated Lipocalin for Early Prediction of Acute Kidney Injury in Patients with Severe Preeclampsia
Brief summary describing the background and objectives of the trial Background: The advent of novel biomarkers of kidney injury has opened a new era for early detection and prognosis prediction of AKI, including urine and plasma neutrophil gelatinase-associated lipocalin (NGAL), a small 25-kDa glycoprotein secreted by activated neutrophils. Firstly identified as a matrix protein of specific granules of human neutrophils. Intrarenal resistance indices (IRIs) can be considered an integrative parameter that may help in detecting renal preclinical dysfunction, renal vascular damages, acute and chronic renal changes in renal vascular compliance and resistances. Objectives: To evaluate the efficacy of renal resistance indices (RRIs) and neutrophil gelatinase-associated lipocalin (NGAL) for early prediction of occurrence and severity of acute kidney injury in patients with severe preeclampsia.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Kidney Disease,Obstetrics and Gynecology,Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied severe preeclampsia
Purpose of the trial Early detection /Screening
Anticipated trial start date 01/12/2019
Actual trial start date
Anticipated date of last follow up 01/05/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 70
Actual target sample size (number of participants)
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
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group renal doppler and renal biomarker no drugs used measurements at first day of admission to intensive care unit NGAL will be measured using Enzyme-Linked Immunosorbent Assay (ELISA) technique according to the standard protocol. Renal colour duplex will be carried out and The following indices will be measured: • Resistive index (RI). • Pulsatile index (PI). • End diastolic flow velocity (Ved) (cm/sec). 35
Control Group serum urea and creatinine level no drugs used daily measurement for 3 days Blood urea (mg/ dl) and Serum creatinine (mg/ dl) measured every 24 hours for 3 consecutive days. 35 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Severe preeclampsia, blood pressure: 160 mm Hg or higher systolic or 110 mm Hg or higher diastolic Proteinuria: 5 g or more of protein in a 24-hour urine collection or 3+ or greater on urine dipstick testing Cerebral or visual disturbances Epigastric or right upper quadrant pain 1. Patients with preexisting renal insufficiency. 2. Patients with a history of dialysis requirement. 3. Diabetes mellitus, essential hypertension and peripheral vascular disease. 4. Use of nephrotoxic drugs before or during the study period. 5. Patients with elevated serum urea and creatinine at time of admission. Adult: 19 Year-44 Year 20 Year(s) 45 Year(s) Female
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 16/05/2018 the ethics committee of the faculty of medicine alexandria university
Ethics Committee Address
Street address City Postal code Country
17 champollion street, el messalah alexandria 21500 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome evaluate the efficacy of renal resistance indices (RRIs) and neutrophil gelatinase-associated lipocalin (NGAL) for early prediction of occurrence and severity of acute kidney injury in patients with severe preeclampsia. first day after delivery in ICU
Secondary Outcome establish a cut-off value for various renal resistance indices and neutrophil gelatinase-associated lipocalin for early prediction of acute kidney injury in patients with severe preeclampsia. first day after delivery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
El shatby maternity hospital el shatby university hospital, el shatby, alexandria, egypt alexandria 21500 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
ahmed ragab 54 el sayed hefny street alexandria 21500 Egypt
Ahmed Ragab abd el kader 54 Elsayed Hefny St. Sidi Gaber discrete Alexandria 21500 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor alexandria faculty of medicine el khartom square, el azarita alexandria 21500 Egypt University
COLLABORATORS
Name Street address City Postal code Country
mohamed sherif 1 hedaya street alexandria 21500 Egypt
Ahmed Yasser Mohram 25 el geish street, alexandria alexandria Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Public Enquiries hesham anwar h.anwar@hotmail.com +201001449108 kafr abdo, alexandria
City Postal code Country Position/Affiliation
alexandria 21500 Egypt assistant prof. at anesthesia department of alexandria university
Role Name Email Phone Street address
Principal Investigator salwa sharawy s.sharawy@yahoo.com +201223425079 san stefano, alexandria
City Postal code Country Position/Affiliation
alexandria 21500 Egypt prof. of anesthesia at faculty of medicine alexandria university
Role Name Email Phone Street address
Scientific Enquiries sally roshdy Srouchdi@yahoo.com +201001818444 roushdy, alexandria
City Postal code Country Position/Affiliation
alexandria 21500 Egypt lecturer of anesthesia at faculty of medicine alexandria university
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes it will include background about the study principles& aims discussion of benefits of screening for AKI through NGAL & renal artery Doppler ethical approval option to freely refuse enrollment into the trial Study Protocol 1 year controlled
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