- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06697743
Post Bariatric Surgery Acute Kidney Injury: Incidence and Risk Factors
November 17, 2024 updated by: Georgina Tharwat Abdelmasih
Bariatric surgery is the most effective means of inducing and maintaining sustained weight loss.
Apart from the weight loss effect, bariatric surgery leads to the remission of chronic metabolic disorders such as type 2 diabetes (T2D) and hypertension .
Recent studies have shown that bariatric surgery improves renal perfusion and glomerular function and reduces inflammatory markers which can lead to an improvement of microalbuminuria and proteinuria However, acute kidney injury (AKI) can complicate the postoperative course after bariatric surgery.
The etiology of AKI after bariatric surgery can be multifactorial and complex in obese population .
The preexisting factors such as diabetes, hypertension, and CKD in these patients can additionally worsen the renal insult during the postoperative period .
Postoperative AKI is associated with increase morbidity and mortality especially in cases of severe AKI that requires dialysis support .
Identifying the high-risk patients for development of postoperative AKI would prevent renal injury.
Our aim was to study the incidence and etiology of postoperative AKI after bariatric surgery .
Causes of post bariatric surgery AKI include .
Pre renal causes :dehydration ( repeated vomiting and diarrhoea)which are common complications post bariatric surgery , haemorrhagic shock (from the site of anastomosis , ulcer ) , septic shock ( leakage , pneumonia) , hypotension and respiratory depression secondary to narcotic overdose.
Rena causes: contract induced nephropathy after using CT scan guided drainage of intra abdominal collection post operative, Rhabdomylosis , drug induced nephropathy e.g :using of IV vancomycin for sepsis in ICU .. many causes can lead to AkI post bariatric surgery but the common two causes are dehydration and sepsis .
Study Overview
Status
Not yet recruiting
Conditions
Study Type
Observational
Enrollment (Estimated)
30
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Georgina Tharwat Abdelmasih, Master
- Phone Number: +20 1203254445 georginatharwat8@gmail.com
- Email: georginatharwat8@gmail.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
multi central study in Egypt
Description
Inclusion criteria:
- Age more than 18 years old undergo bariatric surgery .
- BMI ≥30 : ( BMI = weight in kg / height in m²)
Exclusion criteria:
- previous kidney diseases(AKI , CKD) .
- patients unfit for surgery e.g ( comorbidities : CHD , LCF ) 3. Drugs : (ACE-I , ARBs, and NSAIDS)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
Patient undergo bariatric surgery
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
incidence
Time Frame: Baseline
|
assess the incidence of postoperative AKI after bariatric surgery .
|
Baseline
|
|
Risk factors
Time Frame: Baseline
|
assess the risk factors of postoperative AKI after bariatric surgery
|
Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
duration of hospitalization
Time Frame: Baseline
|
Assess the duration of hospitalization, and it's relation with the incidence of AKI
|
Baseline
|
|
readmission
Time Frame: Baseline
|
Assess the duration of readmission within 30 d after surgery and it's relation with the incidence of AKI
|
Baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Inker LA, Eneanya ND, Coresh J, Tighiouart H, Wang D, Sang Y, Crews DC, Doria A, Estrella MM, Froissart M, Grams ME, Greene T, Grubb A, Gudnason V, Gutierrez OM, Kalil R, Karger AB, Mauer M, Navis G, Nelson RG, Poggio ED, Rodby R, Rossing P, Rule AD, Selvin E, Seegmiller JC, Shlipak MG, Torres VE, Yang W, Ballew SH, Couture SJ, Powe NR, Levey AS; Chronic Kidney Disease Epidemiology Collaboration. New Creatinine- and Cystatin C-Based Equations to Estimate GFR without Race. N Engl J Med. 2021 Nov 4;385(19):1737-1749. doi: 10.1056/NEJMoa2102953. Epub 2021 Sep 23.
- Levin A, Ahmed SB, Carrero JJ, Foster B, Francis A, Hall RK, Herrington WG, Hill G, Inker LA, Kazancioglu R, Lamb E, Lin P, Madero M, McIntyre N, Morrow K, Roberts G, Sabanayagam D, Schaeffner E, Shlipak M, Shroff R, Tangri N, Thanachayanont T, Ulasi I, Wong G, Yang CW, Zhang L, Robinson KA, Wilson L, Wilson RF, Kasiske BL, Cheung M, Earley A, Stevens PE. Executive summary of the KDIGO 2024 Clinical Practice Guideline for the Evaluation and Management of Chronic Kidney Disease: known knowns and known unknowns. Kidney Int. 2024 Apr;105(4):684-701. doi: 10.1016/j.kint.2023.10.016.
- Morgan DJ, Ho KM. Acute kidney injury in bariatric surgery patients requiring intensive care admission: a state-wide, multicenter, cohort study. Surg Obes Relat Dis. 2015 Nov-Dec;11(6):1300-6. doi: 10.1016/j.soard.2015.01.005. Epub 2015 Jan 14.
- Huang H, Lu J, Dai X, Li Z, Zhu L, Zhu S, Wu L. Improvement of Renal Function After Bariatric Surgery: a Systematic Review and Meta-analysis. Obes Surg. 2021 Oct;31(10):4470-4484. doi: 10.1007/s11695-021-05630-4. Epub 2021 Aug 6. Erratum In: Obes Surg. 2021 Nov;31(11):5107. doi: 10.1007/s11695-021-05699-x.
- Lee Y, Anvari S, Chu MM, Lovrics O, Khondker A, Malhan R, Aditya I, Doumouras AG, Walsh M, Hong D. Improvement of kidney function in patients with chronic kidney disease and severe obesity after bariatric surgery: A systematic review and meta-analysis. Nephrology (Carlton). 2022 Jan;27(1):44-56. doi: 10.1111/nep.13958. Epub 2021 Aug 16.
- Wilhelm SM, Young J, Kale-Pradhan PB. Effect of bariatric surgery on hypertension: a meta-analysis. Ann Pharmacother. 2014 Jun;48(6):674-82. doi: 10.1177/1060028014529260. Epub 2014 Mar 24.
- Moriconi D, Manca ML, Anselmino M, Rebelos E, Bellini R, Taddei S, Ferrannini E, Nannipieri M. Predictors of type 2 diabetes relapse after Roux-en-Y Gastric Bypass: A ten-year follow-up study. Diabetes Metab. 2022 Jan;48(1):101282. doi: 10.1016/j.diabet.2021.101282. Epub 2021 Sep 18.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
December 1, 2024
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
February 1, 2027
Study Registration Dates
First Submitted
November 14, 2024
First Submitted That Met QC Criteria
November 17, 2024
First Posted (Estimated)
November 20, 2024
Study Record Updates
Last Update Posted (Estimated)
November 20, 2024
Last Update Submitted That Met QC Criteria
November 17, 2024
Last Verified
November 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Post bariatric surgery AKI
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.