- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06505655
Early Diagnosis of Acute Renal Failure by Urine Trehalase Levels.
July 11, 2024 updated by: İlke Dolgun, Istinye University
Early Diagnosis of Acute Renal Failure, Which May Occur in Patients After Surgeries Requiring Hypotensive Anesthesia, by Urine Trehalase Levels.
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
40
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: ilke dolgun
- Phone Number: +905555485632
- Email: ilkeser2004@gmail.com
Study Locations
-
-
Merkez Mahallesi
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Istanbul, Merkez Mahallesi, Turkey, 34250
- istinye University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Probability 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.
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
trehalase levels
Time Frame: 1 month
|
urine trehalase levels
|
1 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
July 15, 2024
Primary Completion (Estimated)
August 15, 2024
Study Completion (Estimated)
September 15, 2024
Study Registration Dates
First Submitted
July 11, 2024
First Submitted That Met QC Criteria
July 11, 2024
First Posted (Actual)
July 17, 2024
Study Record Updates
Last Update Posted (Actual)
July 17, 2024
Last Update Submitted That Met QC Criteria
July 11, 2024
Last Verified
July 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- istinye university trehalase
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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