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

Completed

• Conditions: Proteinuria; Acute Kidney Injury; Obesity
• Interventions: Other: Urine Sample

• Registration Number: NCT02798042
• Lead Sponsor: NYU Langone Health

Brief Summary

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

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 Timeline

• Study First Submitted: 2016-06-08
• Study First Submitted QC: 2016-06-13
• Study First Posted: 2016-06-14
• Study Start: 2016-06-16
• Primary Completion: 2023-02-02
• Study Completion: 2023-02-02
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-24
• Last Update Posted: 2024-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1434

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

Read More

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.

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patient population	Urine Sample	Patients undergoing bariatric surgery

Primary Outcome Measures

Name	Time	Method
Acute Kidney Injury	24 hours after surgery

Trial Locations

Locations (1)

NYU Langone Medical Center; 🇺🇸 New York, New York, United States