Percutaneous NephrolithotomyNCT06393062
Gram Stain of the First Urine After Puncture in Percutaneous Nephrolithotomy
A study testing Gram staining of the first urine after intraoperative renal puncture to predict the systemic inflammatory response after percutaneous nephrolithotomy. in people with Percutaneous Nephrolithotomy, run by Adiyaman University at 1 site in Turkey (Türkiye).
Trial summary
In this study, investigators compared the systemic inflammatory responses after percutaneous nephrolithotomy (PCNL) patients who were given an expanded empirical antibiotic regimen based on the prediction of the possibility of bacteria identified by Gram staining the first urine after renal puncture and patients whose… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Percutaneous Nephrolithotomy
- What is being tested?
- Gram staining of the first urine after intraoperative renal puncture to predict the systemic inflammatory response after percutaneous nephrolithotomy.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 245 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2022to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with an indication for percutaneous nephrolithotomy due to kidney stone disease.
Who cannot join
- under 18 years old,
- having an active urinary tract infection before surgery and positive urine cultures,
- Patients with bilateral kidney stones,
- DJ stent or nephrostomy placement,
- Solitary kidney stones,
- Bleeding disorders,
- impaired kidney function,
- a history of antibiotic use for any reason within 2 weeks before randomization were excluded from the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Adıyaman University, Medicine of Faculty
Adıyaman, 02400
Bedreddin Kalyenci, MD, +905554859583, bedreddin84@windowslive.com
About this study
Official title: Gram Stain of the First Urine After Intraoperative Renal Puncture in Predicting the Systemic Inflammatory Response After Percutaneous Nephrolithotomy: A Prospective, Randomized Controlled Study
In this study, investigators compared the systemic inflammatory responses after percutaneous nephrolithotomy (PCNL) patients who were given an expanded empirical antibiotic regimen based on the prediction of the possibility of bacteria identified by Gram staining the first urine after renal puncture and patients whose antibiotic regimen was not performed and whose antibiotic regimen was adjusted according to patient symptoms and culture results. Investigators aimed to test its diagnostic value in predicting and preventing complications.
- Conditions
- Percutaneous Nephrolithotomy
- Being tested
- Gram staining of the first urine after intraoperative renal puncture to predict the systemic inflammatory response after percutaneous nephrolithotomy.
- Keywords
- fever, gram stain, percutaneous nephrolithotomy, Systemic inflammatory response syndrome (SIRS)
- Medical subject headings
- Fever, Systemic Inflammatory Response Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gram staining of the first urine after intraoperative renal puncture to predict the systemic inflammatory response after percutaneous nephrolithotomy.Diagnostic test
Gram staining of the first urine after intraoperative renal puncture to predict the systemic inflammatory response after percutaneous nephrolithotomy.
| Study group | Role | What they receive |
|---|---|---|
| Gram staining | Experimental | Gram staining of post-puncture urine in percutaneous nephrolithotomy Receives: Diagnostic Test: Gram staining of the first urine after intraoperative renal puncture to predict the systemic inflammatory response after percutaneous nephrolithotomy. |
| control | No intervention | non-intervention percutaneous nephrolithotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of Gram stain in predicting systemic inflammatory response after percutaneous nephrolithotomy.
Gram staining of urine after puncture to detect the presence of bacteria that are a possible source of infection according to the rate of gram-stained and non-gram-stained patients by microscopic examination.
Measured: immediately after the surgery
Secondary outcomes (1)
Change of antibiotic regimen after bacterial estimation of Gram stain
The percentage of patients whose antibiotic regimen was changed by estimating bacteria after Gram staining did not progress to systemic inflammatory response syndrome. Systemic inflammatory response criteria: temperature less than 36 °C or higher than 38 °C, heart rate more than 100 beats per minute, respiratory rate more than 20 per minute, leukocyte count greater than 12 × 10 up 9/L or 4 × 10 up 9/L less than L, systolic blood pressure falling below 90 mmHg, or diastolic blood pressure falling below 40 mmHg
Measured: immediately after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2024
- Study start1 Dec 2022
- Primary completion31 Aug 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Percutaneous NephrolithotomyStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The patients included in the study were randomized by a block randomization method by an independent researcher, hidden from the patients and the responsible clinicians, using a computerized number tool.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 245 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Adiyaman University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bedreddin Kalyenci, Adiyaman University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06393062
- Sponsor's protocol ID
- 2022/7-17
- Status last verified
- Jan 2025
- First submitted
- 24 Apr 2024
- Last updated
- 22 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Patient clinical data before and after surgery
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gram Stain of the First Urine After Intraoperative Renal Puncture in Predicting the Systemic Inflammatory Response After Percutaneous Nephrolithotomy: A Prospective, Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06393062
- Acronym / sponsor ID
- 2022/7-17
- Conditions
- Percutaneous Nephrolithotomy
- Keywords
- fever, gram stain, percutaneous nephrolithotomy, Systemic inflammatory response syndrome (SIRS)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 245 participants (estimated)
- Lead sponsor
- Adiyaman UniversityUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 31 Aug 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 1 May 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.
In this study, investigators compared the systemic inflammatory responses after percutaneous nephrolithotomy (PCNL) patients who were given an expanded empirical antibiotic regimen based on the prediction of the possibility of bacteria identified by Gram staining the first urine after renal puncture and patients whose antibiotic regimen was not performed and whose antibiotic regimen was adjusted according to patient symptoms and culture results. Investigators aimed to test its diagnostic value in predicting and preventing complications.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- The patients included in the study were randomized by a block randomization method by an independent researcher, hidden from the patients and the responsible clinicians, using a computerized number tool.
| Arm | Type | Receives |
|---|---|---|
| Gram staining | Experimental | Diagnostic Test: Gram staining of the first urine after intraoperative renal puncture to predict the systemic inflammatory response after percutaneous nephrolithotomy.Gram staining of post-puncture urine in percutaneous nephrolithotomy |
| control | No intervention | –non-intervention percutaneous nephrolithotomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients with an indication for percutaneous nephrolithotomy due to kidney stone disease.
Key exclusion criteria (8 listed)
- under 18 years old,
- having an active urinary tract infection before surgery and positive urine cultures,
- Patients with bilateral kidney stones,
- DJ stent or nephrostomy placement,
- Solitary kidney stones,
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 |
|---|---|---|
| Gram staining of the first urine after intraoperative renal puncture to predict the systemic inflammatory response after percutaneous nephrolithotomy.Gram staining of the first urine after intraoperative renal puncture to predict the systemic inflammatory response after percutaneous nephrolithotomy. | Diagnostic test | Gram staining |
Primary outcome
Efficacy of Gram stain in predicting systemic inflammatory response after percutaneous nephrolithotomy.
Time frame: immediately after the surgery
Gram staining of urine after puncture to detect the presence of bacteria that are a possible source of infection according to the rate of gram-stained and non-gram-stained patients by microscopic examination.
1 secondary outcome
Change of antibiotic regimen after bacterial estimation of Gram stain
Time frame: immediately after the surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2025.
- Individual participant dataSharing planned: Yes. Patient clinical data before and after surgery
Related trials for Percutaneous Nephrolithotomy
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Nephrostomy Tract Infiltration for Pain Control After PCNL
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Not yet recruitingPhase 4
Effect of a Low-Dose Ketamine-Dexmedetomidine-Based Opioid-Sparing Anesthesia Protocol on Postoperative Quality of Recovery After Percutaneous Nephrolithotomy
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gram staining of the first urine after intraoperative renal puncture to predict the systemic inflammatory response after percutaneous nephrolithotomy. in people with Percutaneous Nephrolithotomy, run by Adiyaman 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 1 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 22 Jan 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bedreddin Kalyenci (+905554859583, bedreddin84@windowslive.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of Gram stain in predicting systemic inflammatory response after percutaneous nephrolithotomy. (time frame: immediately after the surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Jan 2025.