Does the Presence of Preoperative Proteinuria Predict Postoperative Acute Kidney Injury in Obese Patients Undergoing Elective Laparoscopic Surgery?

July 24, 2024 updated by: NYU Langone Health
Acute kidney injury (AKI) is a common, but significant complication after elective surgery which is associated with an increased risk of mortality, major adverse cardiac events, prolonged length of hospital stay, and increased cost per episode of care.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Acute kidney injury (AKI) is a common, but significant complication after elective surgery which is associated with an increased risk of mortality, major adverse cardiac events, prolonged length of hospital stay, and increased cost per episode of care. Obese patients are at increased risk of postoperative AKI when compared to normal weight patients; however current methods to assess preoperative renal function in this patient population (such as measurement of serum creatinine and calculation of the estimated glomerular filtration rate) have previously been demonstrated to overestimate their true renal function. , Preoperative proteinuria has previously been determined to be predictive of the development of postoperative AKI in patients of all weights undergoing cardiac surgery. Published reports on the prevalence of proteinuria in obese patients span a wide range: from 8- 43%. The investigators aim to determine the predictive value of preoperative proteinuria on the development of postoperative AKI in patients presenting for elective laparoscopic bariatric surgery at NYULMC. The investigators hypothesize that preoperative proteinuria will be associated with an increased incidence of AKI within 48 hours after elective laparoscopic bariatric surgery. Furthermore, since there is a wide range of reported prevalence of proteinuria in the bariatric patient population, part of the value of the study will be to provide a more definitive assessment of the prevalence of proteinuria in this surgical population.

Study Type

Observational

Enrollment (Actual)

1434

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10016
        • NYU Langone Medical Center

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

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients undergoing elective laparoscopic weight loss surgery including: gastric band placement, sleeve gastrectomy, gastric bypass, or a combination of the above procedures.

Description

Inclusion Criteria:

  • ≥ 18 years of age
  • Subjects undergoing elective laparoscopic bariatric surgery at NYULMC, including gastric banding, sleeve gastrectomy, and Roux -en-Y gastric bypass
  • Surgery scheduled at least one day after Pre Admission Testing visit

Exclusion Criteria:

  • Pre-existing end stage renal disease (CrCl <30ml/min and/or need for hemodialysis)
  • Medical history of systemic disease known to cause proteinuria: monoclonal gammopathy, multiple myeloma, primary amyloidosis, diabetic nephropathy, acute myeloblastic leukemia, myoglobinuria, free hemoglobinuria (i.e intravascular hemolysis)
  • Known pregnancy
  • Diagnosis of AKI within 6 months of surgery
  • Diagnosis of cognitive dysfunction (i.e. mental retardation/developmental delay, dementia, delirium)
  • Any subject who the study team feels would be unable to comply with all protocol procedures.

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
Intervention / Treatment
Patient population
Patients undergoing bariatric surgery
Other: Urine Sample
We plan to collect a urine sample during the pre-surgical visit.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Acute Kidney Injury
Time Frame: 24 hours after surgery
24 hours after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NYU Langone Health

Investigators

  • Principal Investigator: Liliya Pospishil, MD, NYU School of Medicine

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 (Actual)

June 16, 2016

Primary Completion (Actual)

February 2, 2023

Study Completion (Actual)

February 2, 2023

Study Registration Dates

First Submitted

June 8, 2016

First Submitted That Met QC Criteria

June 13, 2016

First Posted (Estimated)

June 14, 2016

Study Record Updates

Last Update Posted (Actual)

July 26, 2024

Last Update Submitted That Met QC Criteria

July 24, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16-00775

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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