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Bariatric SurgeryNCT06697743

Post Bariatric Surgery Acute Kidney Injury: Incidence and Risk Factors

An observational study of Bariatric Surgery and Acute Kidney Injury, run by Georgina Tharwat Abdelmasih.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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 . Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Bariatric Surgery, Acute Kidney Injury
How many people
30 participants
Where
No sites listed yet
Study dates
1 Dec 2024to Feb 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: multi central study in Egypt

  1. Inclusion criteria:
  2. Age more than 18 years old undergo bariatric surgery .
  3. BMI ≥30 : ( BMI = weight in kg / height in m²)
  4. Exclusion criteria:
  5. previous kidney diseases(AKI , CKD) .
  6. patients unfit for surgery e.g ( comorbidities : CHD , LCF ) 3. Drugs : (ACE-I , ARBs, and NSAIDS)

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Georgina Tharwat Abdelmasih, Master contact

georginatharwat8@gmail.com ext. +20 1203254445

georginatharwat8@gmail.com

About this study

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 .

Keywords
Bariatric surgery, Acute kidney injury
Medical subject headings
Acute Kidney Injury

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06697743
Study groupRoleWhat they receive
Patient undergo bariatric surgery1. Inclusion criteria: 1. Age more than 18 years old undergo bariatric surgery . 2. BMI ≥30 : ( BMI = weight in kg / height in m²) 2. Exclusion criteria: 1. previous kidney diseases(AKI , CKD) . 2. patients unfit for surgery e.g ( comorbidities : CHD , LCF ) 3. Drugs : (ACE-I , ARBs, and NSAIDS)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. incidence

    assess the incidence of postoperative AKI after bariatric surgery .

    Measured: Baseline

  2. Risk factors

    assess the risk factors of postoperative AKI after bariatric surgery

    Measured: Baseline

Secondary outcomes (2)

  1. duration of hospitalization

    Assess the duration of hospitalization, and it's relation with the incidence of AKI

    Measured: Baseline

  2. readmission

    Assess the duration of readmission within 30 d after surgery and it's relation with the incidence of AKI

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Nov 2024
  2. Study start1 Dec 2024 (estimated)
  3. Primary completion1 Dec 2026 (estimated)
  4. Study completionFeb 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06697743
Sponsor's protocol ID
Post bariatric surgery AKI
Status last verified
Nov 2024
First submitted
14 Nov 2024
Last updated
20 Nov 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

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.

    PubMed 34554658

  • 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.

    PubMed 38519239

  • 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.

    PubMed 25892347

  • 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.

    PubMed 34355340

  • 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.

    PubMed 34375462

  • 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.

    PubMed 24662112

  • 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.

    PubMed 34547450

Questions about this trial

What is this clinical trial studying?

An observational study of Bariatric Surgery and Acute Kidney Injury, run by Georgina Tharwat Abdelmasih.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 20 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Georgina Tharwat Abdelmasih, Master (georginatharwat8@gmail.com ext. +20 1203254445, georginatharwat8@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

incidence (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06697743, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2024.

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