NCT06505655

Brief Summary

We think that in surgical patients requiring hypotensive anesthesia, acute kidney injury, which may occur due to intraoperative renal hypoperfusion, can be diagnosed early by evaluating the urine trehalase value using the ELISA method, and thus, early diagnosed acute renal failure can be treated quickly and patients can be protected from subsequent complications in the postoperative period.

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
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

July 11, 2024

Completed
4 days until next milestone

Study Start

First participant enrolled

July 15, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 17, 2024

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2024

Completed
Last Updated

July 17, 2024

Status Verified

July 1, 2024

Enrollment Period

1 month

First QC Date

July 11, 2024

Last Update Submit

July 11, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • trehalase levels

    urine trehalase levels

    1 month

Interventions

trehalase levelsDIAGNOSTIC_TEST

We think that in surgical patients requiring hypotensive anesthesia, acute kidney injury, which may occur due to intraoperative renal hypoperfusion, can be diagnosed early by evaluating the urine trehalase value using the ELISA method

Eligibility Criteria

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

40 patients between the ages of 18-65 who underwent a surgical operation requiring hypotensive anesthesia will be included in the study.

You may qualify if:

  • Being over the age of 18 and under the age of 65
  • Having signed the BGOF form to be included in the study,
  • Being in ASA 1 or ASA 2 classification
  • Not having kidney failure or kidney disease
  • No history of single kidney or renal transplantation
  • Not using nephrotoxic drugs or agents before surgery
  • Renal function tests taken preoperatively should be within normal ranges.
  • No urinary tract infection or urinary problems (such as polyuria, oliguria or anuria)

You may not qualify if:

  • Those under the age of 18 or over the age of 65
  • Those who do not want to participate in the study
  • ASA 3 and above
  • Having previously received treatment for kidney disease - including kidney stones -
  • Having been previously diagnosed with acute or chronic renal failure
  • Having a single kidney or a history of renal transplantation
  • Using nephrotoxic drugs or agents (such as contrast material) before surgery
  • Kidney function tests taken preoperatively are not within normal ranges
  • Having a urinary tract infection or urinary problem (such as polyuria, oliguria or anuria)
  • Having a history of kidney stones, acute renal failure or chronic renal failure
  • Those with active infection or disease before surgery
  • They were determined as patients for whom consent was not obtained for the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istinye Üniversity

Istanbul, Merkez Mahallesi, 34250, Turkey (Türkiye)

Location

Related Publications (4)

  • Chavan S, Hase N, Chavan P. Urinary enzymes in nephrotic syndrome. Indian J Clin Biochem. 2005 Jul;20(2):126-30. doi: 10.1007/BF02867411.

    PMID: 23105544BACKGROUND
  • Ouyang Y, Xu Q, Mitsui K, Motizuki M, Xu Z. Human trehalase is a stress responsive protein in Saccharomyces cerevisiae. Biochem Biophys Res Commun. 2009 Feb 6;379(2):621-5. doi: 10.1016/j.bbrc.2008.12.134. Epub 2009 Jan 4.

    PMID: 19126402BACKGROUND
  • Sasai-Takedatsu M, Kojima T, Taketani S, Ono A, Kitamura N, Kobayashi Y. Urinary trehalase activity is a useful marker of renal proximal tubular damage in newborn infants. Nephron. 1995;70(4):443-8. doi: 10.1159/000188643.

  • Sasai-Takedatsu M, Taketani S, Nagata N, Furukawa T, Tokunaga R, Kojima T, Kobayashi Y. Human trehalase: characterization, localization, and its increase in urine by renal proximal tubular damage. Nephron. 1996;73(2):179-85. doi: 10.1159/000189037.

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. prof

Study Record Dates

First Submitted

July 11, 2024

First Posted

July 17, 2024

Study Start

July 15, 2024

Primary Completion

August 15, 2024

Study Completion

September 15, 2024

Last Updated

July 17, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations