Trehalase LevelsNCT06505655
Early Diagnosis of Acute Renal Failure by Urine Trehalase Levels.
An observational study of Trehalase Levels and Acute Kidney Injury, run by Istinye University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Trehalase Levels, Acute Kidney Injury
- What is being tested?
- trehalase levels
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jul 2024to 15 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 40 patients between the ages of 18-65 who underwent a surgical operation requiring hypotensive anesthesia will be included in the study.
Who may be able to join
- 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)
Who cannot join
- 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
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istinye Üniversity
Istanbul, Merkez Mahallesi, 34250
About this study
Official title: 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.
- Conditions
- Trehalase Levels, Acute Kidney Injury
- Being tested
- trehalase levels
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
What is being measured
The primary outcome is the main question the study is designed to answer.
trehalase levels
urine trehalase levels
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2024
- Study start15 Jul 2024 (estimated)
- Primary completion15 Aug 2024 (estimated)
- Study completion15 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Trehalase LevelsStudies of the same condition, open and under way.
- More trials run by Istinye UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istinye University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, İlke Dolgun, Istinye University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06505655
- Sponsor's protocol ID
- istinye university trehalase
- Status last verified
- Jul 2024
- First submitted
- 11 Jul 2024
- Last updated
- 17 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 23105544Ouyang 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.
PubMed 19126402Sasai-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.
PubMed 7477650Sasai-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.
PubMed 8773341
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Diagnosis of Acute Renal Failure, Which May Occur in Patients After Surgeries Requiring Hypotensive Anesthesia, by Urine Trehalase Levels.
- ClinicalTrials.gov ID
- NCT06505655
- Acronym / sponsor ID
- istinye university trehalase
- Conditions
- Trehalase Levels, Acute Kidney Injury
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Istinye UniversityUniversity, hospital or other
- Study start
- 15 Jul 2024 (estimated)
- Primary completion
- 15 Aug 2024 (estimated)
- Study completion
- 15 Sep 2024 (estimated)
- First posted
- 17 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 40 patients between the ages of 18-65 who underwent a surgical operation requiring hypotensive anesthesia will be included in the study.
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| trehalase levelsWe 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 | Diagnostic test | – |
Primary outcome
trehalase levels
Time frame: 1 month
urine trehalase levels
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2024.
- Background: PubMed 23105544Chavan S, Hase N, Chavan P. Urinary enzymes in nephrotic syndrome. Indian J Clin Biochem. 2005 Jul;20(2):126-30. doi: 10.1007/BF02867411.
- Background: PubMed 19126402Ouyang 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.
- Results publication: PubMed 7477650Sasai-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.
- Results publication: PubMed 8773341Sasai-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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Trehalase Levels and Acute Kidney Injury, run by Istinye University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ilke dolgun (+905555485632, ilkeser2004@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
trehalase levels (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06505655, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2024.