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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03675906
Other study ID # ERZINCAN BINALI YILDIRIM
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date September 12, 2018
Est. completion date December 30, 2018

Study information

Verified date September 2018
Source Erzincan University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 160
Est. completion date December 30, 2018
Est. primary completion date December 15, 2018
Accepts healthy volunteers No
Gender All
Age group 65 Years and older
Eligibility 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 Design


Intervention

Other:
hypoalbuminemia
hypoalbuminemia and acute kidney injury

Locations

Country Name City State
Turkey Erzincan University Erzincan

Sponsors (1)

Lead Sponsor Collaborator
Erzincan University

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

Kim HJ, Koh WU, Kim SG, Park HS, Song JG, Ro YJ, Yang HS. Early postoperative albumin level following total knee arthroplasty is associated with acute kidney injury: A retrospective analysis of 1309 consecutive patients based on kidney disease improving g — View Citation

Kim K, Bang JY, Kim SO, Kim S, Kim JU, Song JG. Association of preoperative hypoalbuminemia with postoperative acute kidney injury in patients undergoing brain tumor surgery: a retrospective study. J Neurosurg. 2018 Apr;128(4):1115-1122. doi: 10.3171/2016 — View Citation

Section 2: AKI Definition. Kidney Int Suppl (2011). 2012 Mar;2(1):19-36. — View Citation

Shin KH, Han SB. Early postoperative hypoalbuminemia is a risk factor for postoperative acute kidney injury following hip fracture surgery. Injury. 2018 Aug;49(8):1572-1576. doi: 10.1016/j.injury.2018.05.001. Epub 2018 May 2. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary hypoalbuminemia and AKI - incidence of AKI hypoalbuminemia and incidence of AKI according to KDIGO criterias 3 months
Secondary anesthesia type - incidence of AKI incidence of AKI according to anesthesia type 3 months
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