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 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201707001753286 Date of Registration: 24/08/2016
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Acute kidney injury in morbid obese patients undergoing laparoscopic bariatric surgery and role of dopamine for renal protection: prospective comparat
Official scientific title Acute kidney injury in morbid obese patients undergoing laparoscopic bariatric surgery and role of dopamine for renal protection: prospective comparative study
Brief summary describing the background and objectives of the trial Currently, one of the most pressing health crises in the nation is the rise in obesity. Morbid obesity is considered as independent risk factor for the development of chronic kidney diseases (16-18). Obesity-related glomerulopathy together with other morbid obesity associated co-morbidity (diabetes mellitus and hypertension) increase the vulnerability of the morbid obese patients for the development of AKI (19). The incidence of AKI after bariatric surgery may be threefold to sevenfold higher when compared to normal weight patients (20-22). The aim of the study to evaluate the incidence of acute kidney injury in laparoscopic bariatric surgery and the role of neutrophil gelatinase-associated lipocalin for early diagnosis of AKI as well as evaluation of the role of dopamine in the protection against AKI in laparoscopic bariatric surgery.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Kidney Disease,obesity and acute kideny injury,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 01/06/2016
Actual trial start date 02/07/2016
Anticipated date of last follow up 01/05/2017
Actual Last follow-up date 01/06/2017
Anticipated target sample size (number of participants) 64
Actual target sample size (number of participants) 70
Recruitment status Not yet recruiting
Publication URL 31047\07\16
Secondary Ids Issuing authority/Trial register
31047\07\16 research ethics committee
31047\07\16 research ethics committee
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 Stratified allocation where factors such as age, gender, centre, or previous treatment are used in the stratification (please specify factors used for stratification) Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group group I (normal saline group) The control group received an equivalent volume of 0.9% saline for the same duration till end of surgery Patients will receive ranitidine 150 mg about 30 min before surgery. On arrival to the operating room, intravenous line will be established. Patients will be monitored by noninvasive blood pressure, pulse oximetery, neuromuscular monitor and electrocardiography. Patients will be placed in ramped position where the tragus of the ear will be with the level of sternum. Adequate pre-oxygenation will b 35 Placebo
Experimental Group group II (dopamine group) dopamine infusion will be started after induction of anesthesia at dose of 3¿g/kg/min. dopamine will be prepared in 50 ml syringes by resident anesthesiologist who is not involved in the study infusion started after induction till end of surgery Patients will receive ranitidine 150 mg about 30 min before surgery. On arrival to the operating room, intravenous line will be established. Patients will be monitored by noninvasive blood pressure, pulse oximetery, neuromuscular monitor and electrocardiography. Patients will be placed in ramped position where the tragus of the ear will be with the level of sternum. Adequate pre-oxygenation 35
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
70 obese adult patients aged 18-60 years, ASA II with body mass index ¿ 40 kg/m2 scheduled for laparoscopic bariatric surgery will be included in the study. Patients with chronic renal diseases, need renal replacement therapy, history of coagulapathy, on angiotensin-converting enzyme inhibitors (ACE-I), uncontrolled hypertension, uncontrolled cardiovascular diseases, history of cerebrovascular diseases, uncontrolled respiratory morbidities and hepatic dysfunction will be excluded. 18 Year(s) 60 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 02/07/2016 research ethics committee
Ethics Committee Address
Street address City Postal code Country
elgeish street tanta 3333 Egypt
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 02/07/2016 research ethics committee
Ethics Committee Address
Street address City Postal code Country
elgeish street tanta 33333 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome to evaluate the incidence of acute kidney injury in laparoscopic bariatric surgery Increased levels of serum creatinine level ¿ 0.3 mg/dl or ¿1.5-2 fold from baseline level or urine output less than 0.5 ml/kg/h for 6 h will be used to define development of acute kidney injury (1).
Secondary Outcome to studythe role of neutrophil gelatinase-associated lipocalin for early diagnosis of AKI as well as evaluation of the role of dopamine in the protection against AKI in laparoscopic bariatric surgery. Serum and urine samples for estimation of neutrophil gelatinase-associated lipocalin will be taken 24 hr postoperative. Serum creatinine will be measured 48 hr postoperative. Postoperative complications, ICU and hospital stay will be re
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
anesthesiology department elgeish street tanta 1111 Egypt
tanta university hospitals elgeish street tanta 2222 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
anesthesiology department elgeish street tanta 1111 Egypt
faculty of medicine elgeish street tanta 4444 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor tanta university hospitals elgeish street tanta 2222 Egypt Hospital
Primary Sponsor faculty of medicine elgeish street tanta 4444 Egypt University
COLLABORATORS
Name Street address City Postal code Country
gehan morsy eid 7 tharwat street tanta 1147 Egypt
Mohamed Mohye Eldin AbuElyazed 15 elestad street tanta 5555 Egypt
Shaimaa Farouk Abd El Kader 1 moheb street elmahala elkopra 6666 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator gehan eid gehan2552011@gmail.com 01287466651 7 tharwat street
City Postal code Country Position/Affiliation
tanta 1147 Egypt Lecturer of Anaesthesia and and Intesive care
Role Name Email Phone Street address
Public Enquiries mohammed aboelyazed mohd_yazed@yahoo.com 01120014472 15 elestad street
City Postal code Country Position/Affiliation
tanta 5555 Egypt Lecturer of Anaesthesia and and Intesive care
Role Name Email Phone Street address
Scientific Enquiries shaimaa abdlelkader shaimaafarouk7777@yahoo.com 01270440771 1moheb street
City Postal code Country Position/Affiliation
elmahala elkopra 6666 Egypt Lecturer of Anaesthesia and and Intesive care
REPORTING
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Changes to trial information