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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

multi central study in Egypt

Description

  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)

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Georgina Tharwat Abdelmasih

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Assiut University

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

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 14, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 17, 2024

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 20, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 20, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 17, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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