NCT06697743

Brief 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 . 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 .

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
9mo left

Started Dec 2024

Typical duration for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress66%
Dec 2024Feb 2027

First Submitted

Initial submission to the registry

November 14, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 20, 2024

Completed
11 days until next milestone

Study Start

First participant enrolled

December 1, 2024

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2027

Last Updated

November 20, 2024

Status Verified

November 1, 2024

Enrollment Period

2 years

First QC Date

November 14, 2024

Last Update Submit

November 17, 2024

Conditions

Keywords

Bariatric surgeryAcute kidney injury

Outcome Measures

Primary Outcomes (2)

  • incidence

    assess the incidence of postoperative AKI after bariatric surgery .

    Baseline

  • Risk factors

    assess the risk factors of postoperative AKI after bariatric surgery

    Baseline

Secondary Outcomes (2)

  • duration of hospitalization

    Baseline

  • readmission

    Baseline

Study Arms (1)

Patient undergo bariatric surgery

1. 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)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

multi central study in Egypt

You may qualify if:

  • Age more than 18 years old undergo bariatric surgery .
  • BMI ≥30 : ( BMI = weight in kg / height in m²)

You may not qualify if:

  • previous kidney diseases(AKI , CKD) .
  • patients unfit for surgery e.g ( comorbidities : CHD , LCF ) 3. Drugs : (ACE-I , ARBs, and NSAIDS)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (7)

  • 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.

    PMID: 34554658BACKGROUND
  • 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.

    PMID: 38519239BACKGROUND
  • 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.

    PMID: 25892347BACKGROUND
  • 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.

    PMID: 34355340BACKGROUND
  • 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.

    PMID: 34375462BACKGROUND
  • 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.

    PMID: 24662112BACKGROUND
  • 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.

    PMID: 34547450BACKGROUND

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Central Study Contacts

Georgina Tharwat Abdelmasih, Master

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Dr Georgina Tharwat

Study Record Dates

First Submitted

November 14, 2024

First Posted

November 20, 2024

Study Start

December 1, 2024

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

February 1, 2027

Last Updated

November 20, 2024

Record last verified: 2024-11