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

NCT ID: NCT02798042

Last Updated: 2024-07-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1434 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-06-16

Study Completion Date

2023-02-02

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Acute Kidney Injury Obesity Proteinuria

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patient population

Patients undergoing bariatric surgery

Urine Sample

Intervention Type OTHER

We plan to collect a urine sample during the pre-surgical visit.

Interventions

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Urine Sample

We plan to collect a urine sample during the pre-surgical visit.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Liliya Pospishil, MD

Role: PRINCIPAL_INVESTIGATOR

NYU School of Medicine

Locations

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NYU Langone Medical Center

New York, New York, United States

Site Status

Countries

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United States

References

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Kork F, Balzer F, Spies CD, Wernecke KD, Ginde AA, Jankowski J, Eltzschig HK. Minor Postoperative Increases of Creatinine Are Associated with Higher Mortality and Longer Hospital Length of Stay in Surgical Patients. Anesthesiology. 2015 Dec;123(6):1301-11. doi: 10.1097/ALN.0000000000000891.

Reference Type BACKGROUND
PMID: 26492475 (View on PubMed)

Bell S, Dekker FW, Vadiveloo T, Marwick C, Deshmukh H, Donnan PT, Van Diepen M. Risk of postoperative acute kidney injury in patients undergoing orthopaedic surgery--development and validation of a risk score and effect of acute kidney injury on survival: observational cohort study. BMJ. 2015 Nov 11;351:h5639. doi: 10.1136/bmj.h5639.

Reference Type BACKGROUND
PMID: 26561522 (View on PubMed)

Coca SG, Singanamala S, Parikh CR. Chronic kidney disease after acute kidney injury: a systematic review and meta-analysis. Kidney Int. 2012 Mar;81(5):442-8. doi: 10.1038/ki.2011.379. Epub 2011 Nov 23.

Reference Type BACKGROUND
PMID: 22113526 (View on PubMed)

Uchino S, Bellomo R, Bagshaw SM, Goldsmith D. Transient azotaemia is associated with a high risk of death in hospitalized patients. Nephrol Dial Transplant. 2010 Jun;25(6):1833-9. doi: 10.1093/ndt/gfp624. Epub 2010 Jan 6.

Reference Type BACKGROUND
PMID: 20054022 (View on PubMed)

Coca SG, Jammalamadaka D, Sint K, Thiessen Philbrook H, Shlipak MG, Zappitelli M, Devarajan P, Hashim S, Garg AX, Parikh CR; Translational Research Investigating Biomarker Endpoints in Acute Kidney Injury Consortium. Preoperative proteinuria predicts acute kidney injury in patients undergoing cardiac surgery. J Thorac Cardiovasc Surg. 2012 Feb;143(2):495-502. doi: 10.1016/j.jtcvs.2011.09.023. Epub 2011 Nov 3.

Reference Type BACKGROUND
PMID: 22050987 (View on PubMed)

Li SY, Chuang CL, Yang WC, Lin SJ. Proteinuria predicts postcardiotomy acute kidney injury in patients with preserved glomerular filtration rate. J Thorac Cardiovasc Surg. 2015 Mar;149(3):894-9. doi: 10.1016/j.jtcvs.2014.10.054. Epub 2014 Oct 14.

Reference Type BACKGROUND
PMID: 25433643 (View on PubMed)

Palomar R, Fernandez-Fresnedo G, Dominguez-Diez A, Lopez-Deogracias M, Olmedo F, Martin de Francisco AL, Sanz de Castro S, Casado Martin F, Gomez-Fleitas M, Arias M, Fernandez-Escalante C. Effects of weight loss after biliopancreatic diversion on metabolism and cardiovascular profile. Obes Surg. 2005 Jun-Jul;15(6):794-8. doi: 10.1381/0960892054222687.

Reference Type BACKGROUND
PMID: 15978149 (View on PubMed)

Other Identifiers

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16-00775

Identifier Type: -

Identifier Source: org_study_id

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