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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03675906
Recruitment Status : Active, not recruiting
First Posted : September 18, 2018
Last Update Posted : September 18, 2018
Sponsor:
Information provided by (Responsible Party):
ILKE KUPELI, Erzincan University

Brief Summary:
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.

Condition or disease Intervention/treatment
Hypoalbuminemia Acute Kidney Failure Other: hypoalbuminemia

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Study Type : Observational
Estimated Enrollment : 160 participants
Observational Model: Case-Crossover
Time Perspective: Retrospective
Official Title: The Relationship Between Preoperative and Postoperative Hypoalbuminemia and Development of Acute Kidney Failure (AKI) According to KDIGO Criteria in Advanced Age Hip Kidney Surgery
Actual Study Start Date : September 12, 2018
Estimated Primary Completion Date : December 15, 2018
Estimated Study Completion Date : December 30, 2018

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. hypoalbuminemia and AKI - incidence of AKI [ Time Frame: 3 months ]
    hypoalbuminemia and incidence of AKI according to KDIGO criterias


Secondary Outcome Measures :
  1. anesthesia type - incidence of AKI [ Time Frame: 3 months ]
    incidence of AKI according to anesthesia type



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03675906


Locations
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Turkey
Erzincan University
Erzincan, Turkey, 24100
Sponsors and Collaborators
Erzincan University
Publications of Results:
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Responsible Party: ILKE KUPELI, principal investigator, Erzincan University
ClinicalTrials.gov Identifier: NCT03675906    
Other Study ID Numbers: ERZINCAN BINALI YILDIRIM
First Posted: September 18, 2018    Key Record Dates
Last Update Posted: September 18, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by ILKE KUPELI, Erzincan University:
hypoalbuminemia
Acute Kidney Failure
older age
hip fracture
Additional relevant MeSH terms:
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Renal Insufficiency
Acute Kidney Injury
Hypoalbuminemia
Kidney Diseases
Urologic Diseases
Hypoproteinemia
Blood Protein Disorders
Hematologic Diseases