NCT02233010

Brief Summary

Although post-op renal function decrease is determined by serum creatinine, serum creatinine has disadvantages that it increases a long time after renal function decrease and it has various increasing time based on the level of renal function. Neutrophil Gelatinase-associated Lipocalin (NGAL's) usefulness as an evidence for acute kidney damage occurring from post-op cardiac surgery, being critical patients and contrast medium use is already proven. But NGAL's usefulness for renal function after non-cardiac surgery is not proven and especially, NGAL's usefulness for renal injury after non-cardiac surgery in chronic renal disease patients is not proven.Therefore, the investigators will study about renal function decrease after non-cardiac surgery with NGAL and serum creatinine.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
43

participants targeted

Target at P25-P50 for all trials

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 1, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 8, 2014

Completed
Last Updated

September 8, 2014

Status Verified

September 1, 2014

Enrollment Period

6 months

First QC Date

September 1, 2014

Last Update Submit

September 5, 2014

Conditions

Outcome Measures

Primary Outcomes (1)

  • serum NGAL level

    up to post operation 12 hours

Study Arms (2)

kidney function normal group

kidney function normal group : defined by the normal level of NGAL after post operation 4hrs

Other: The level of NGAL after pre op,post op 4hr, post op 12hr

kidney function decreased group

kidney function decreased group : defined by the increased level of NGAL after post operation 4hrs

Other: The level of NGAL after pre op,post op 4hr, post op 12hr

Interventions

kidney function decreased groupkidney function normal group

Eligibility Criteria

Age18 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

43 patients who had non-cardiac surgery in Seoul Paik Hospital.

You may qualify if:

  • patients who had non-cardiac surgery in Seoul Paik Hospital.

You may not qualify if:

  • have viral hepatitis and Aspartate aminotransferase, Alanine aminotransferase \> 2 time of normal level
  • severe lung disease
  • severe heart failure ( Ejection Fraction \< 40% )
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Hoseok Koo

Study Record Dates

First Submitted

September 1, 2014

First Posted

September 8, 2014

Study Start

February 1, 2014

Primary Completion

August 1, 2014

Last Updated

September 8, 2014

Record last verified: 2014-09