The Relationship Between Hypoalbuminemia and Development of Acute Kidney Failure (AKI) According to KDIGO Criteria

September 17, 2018 updated by: ILKE KUPELI, Erzincan University

The Relationship Between Preoperative and Postoperative Hypoalbuminemia and Development of Acute Kidney Failure (AKI) According to KDIGO Criteria in Advanced Age Hip Kidney Surgery

This study was designed to determine the association between preoperative and postoperative hypoalbuminemia and AKI in older age hip fracture surgeons, to determine which period of hypoalbuminemia contributes more to AKI development, the incidence of AKI according to anesthesia type, the presence of other factors affecting AKI development, the duration of hospitalization and cost- to be investigated.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

160

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

  • Turkey
      • Erzincan, Turkey, 24100
        • Erzincan University

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

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

ASA I - IV physical status and under spinal anesthesia or peripheric nerve block, 160 patients over 65 years of age undergoing femoral fracture surgery between 01.01.2018 - 01.07.2018

Description

Inclusion Criteria:

  • patients with femur fracture surgery
  • 65 years and over
  • Patients with ASA I - IV physical condition
  • patients with spinal anesthesia or peripheral nerve block

Exclusion Criteria:

  • Patients undergoing emergency surgery
  • patients with preoperative serum creatinine (sCr) level> 1.5 mg / dl
  • patients with low serum albumin levels in both preoperative and postoperative periods
  • patients receiving preoperative ventilator care
  • patients with spinal anesthesia or peripheral nerve block contraindications (coagulopathies, local infection at the puncture site, spot infection) or nonsteroidal antiinflammatory drug (NSAID)

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

  • Observational Models: Case-Crossover
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
preoperative albumin levels <3.8
Other: hypoalbuminemia
hypoalbuminemia and acute kidney injury
preoperative albumin level >3.8
Other: hypoalbuminemia
hypoalbuminemia and acute kidney injury
postoperative Day 2 albumin level <2.9
Other: hypoalbuminemia
hypoalbuminemia and acute kidney injury
postoperative Day 2 albumin level >2.9
Other: hypoalbuminemia
hypoalbuminemia and acute kidney injury

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
hypoalbuminemia and AKI - incidence of AKI
Time Frame: 3 months
hypoalbuminemia and incidence of AKI according to KDIGO criterias
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
anesthesia type - incidence of AKI
Time Frame: 3 months
incidence of AKI according to anesthesia type
3 months

Collaborators and Investigators

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

Sponsor

Erzincan 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 (Actual)

September 12, 2018

Primary Completion (Anticipated)

December 15, 2018

Study Completion (Anticipated)

December 30, 2018

Study Registration Dates

First Submitted

September 12, 2018

First Submitted That Met QC Criteria

September 17, 2018

First Posted (Actual)

September 18, 2018

Study Record Updates

Last Update Posted (Actual)

September 18, 2018

Last Update Submitted That Met QC Criteria

September 17, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ERZINCAN BINALI YILDIRIM

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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