Clinical trial NCT06505655: Early Diagnosis of Acute Renal Failure by Urine Trehalase Levels.
Official title: Early Diagnosis of Acute Renal Failure, Which May Occur in Patients After Surgeries Requiring Hypotensive Anesthesia, by Urine Trehalase Levels.
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Trehalase Levels
Acute Kidney Injury
Lead sponsor: Istinye University
Sponsor class: OTHER
First posted: 2024-07-17
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: trehalase levels
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istinye Üniversity
state: Merkez Mahallesi
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.