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

Sponsor
NYU Langone Health (Other)
Overall Status
Recruiting
CT.gov ID
NCT02798042
Collaborator
(none)
1,800
1
75
24

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Urine Sample

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 Design

Study Type:
Observational
Anticipated Enrollment :
1800 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Does the Presence of Preoperative Proteinuria Predict Postoperative Acute Kidney Injury in Obese Patients Undergoing Elective Laparoscopic Surgery?
Study Start Date :
Jun 1, 2016
Anticipated Primary Completion Date :
Sep 1, 2022
Anticipated Study Completion Date :
Sep 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Patient population

Patients undergoing bariatric surgery

Other: Urine Sample
We plan to collect a urine sample during the pre-surgical visit.

Outcome Measures

Primary Outcome Measures

  1. Acute Kidney Injury [24 hours after surgery]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 NYU Langone Medical Center New York New York United States 10016

Sponsors and Collaborators

  • NYU Langone Health

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
NYU Langone Health
ClinicalTrials.gov Identifier:
NCT02798042
Other Study ID Numbers:
  • 16-00775
First Posted:
Jun 14, 2016
Last Update Posted:
May 31, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 31, 2022