NCT03675906

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 12, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

September 12, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 18, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2018

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2018

Completed
Last Updated

September 18, 2018

Status Verified

September 1, 2018

Enrollment Period

3 months

First QC Date

September 12, 2018

Last Update Submit

September 17, 2018

Conditions

HypoalbuminemiaAcute Kidney Failure

Keywords

hypoalbuminemiaAcute Kidney Failureolder agehip fracture

Outcome Measures

Primary Outcomes (1)

  • hypoalbuminemia and AKI - incidence of AKI

    hypoalbuminemia and incidence of AKI according to KDIGO criterias

    3 months

Secondary Outcomes (1)

  • anesthesia type - incidence of AKI

    3 months

Study Arms (4)

preoperative albumin levels <3.8

Other: hypoalbuminemia

preoperative albumin level >3.8

Other: hypoalbuminemia

postoperative Day 2 albumin level <2.9

Other: hypoalbuminemia

postoperative Day 2 albumin level >2.9

Other: hypoalbuminemia

Interventions

hypoalbuminemiaOTHER

hypoalbuminemia and acute kidney injury

postoperative Day 2 albumin level <2.9postoperative Day 2 albumin level >2.9preoperative albumin level >3.8preoperative albumin levels <3.8

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodProbability 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

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erzincan University

Erzincan, 24100, Turkey (Türkiye)

Location

Related Publications (4)

  • Section 2: AKI Definition. Kidney Int Suppl (2011). 2012 Mar;2(1):19-36. doi: 10.1038/kisup.2011.32. No abstract available.

    PMID: 25018918RESULT

  • 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 global outcomes criteria. Medicine (Baltimore). 2016 Aug;95(31):e4489. doi: 10.1097/MD.0000000000004489.

    PMID: 27495094RESULT

  • 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: 10.3171/2016.11.JNS162237. Epub 2017 May 5.

    PMID: 28474996RESULT

  • 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.

    PMID: 29908852RESULT

MeSH Terms

Conditions

HypoalbuminemiaAcute Kidney InjuryHip Fractures

Condition Hierarchy (Ancestors)

HypoproteinemiaBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesFemoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

September 12, 2018

First Posted

September 18, 2018

Study Start

September 12, 2018

Primary Completion

December 15, 2018

Study Completion

December 30, 2018

Last Updated

September 18, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)