Renal StoneNCT06110247
Evaluation of Renal Oxygenation by NIRS in Pediatric Endourologic Stone Surgery
An observational study of Renal Stone and Kidney; Complications, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
The study aims to compare renal oxygenation levels in retrograde intrarenal surgery (RIRS) and ureteroscopy (URS) procedures with a control group. Additionally, it seeks to determine if there is a connection between postoperative infection parameters and intraoperative renal oxygenation measurements. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Renal Stone, Kidney; Complications, Ureter Stone
- What is being tested?
- NIRS and Taking a blood sample
- Type of treatment
- Medical device
- How many people
- 136 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Nov 2023to 30 Apr 2024
- How long will I take part?
- 2 Days
- 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 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: ASA I-III class between the ages of 1-18, patients who will undergo RIRS and URS surgery under standard general anesthesia, as well as patients who will undergo hypospadias surgery (without a history of stones or kidney problems).
Who may be able to join
- 1-18 years ASA I-III class,
- Patients who will undergo RIRS, URS and Hypospadias surgeries under standard general anesthesia.
- Patients whose informed consent form is approved by their parents will be included in the study.
Who cannot join
- Exclusio criteria were the history of renal failure, renal tumors, infection of the perirenal region; receiving colloid or blood transfusion, having abscess, body mass index (BMI) not in the normal limits (≤3% or ≥97%)
- Patients whose parents do not approve the informed consent form will not be included in the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Bilkent City Hospital,Department Of Anesthesiology and Reanimation
Ankara, Çankaya, 06800
About this study
Official title: Evaluation of Renal Oxygenation in Pediatric Retrograde Intrarenal Surgery (RIRS) and Ureteroscopy (URS) Procedures by Near Infrared Spectroscopy (NIRS)
The study aims to compare renal oxygenation levels in retrograde intrarenal surgery (RIRS) and ureteroscopy (URS) procedures with a control group. Additionally, it seeks to determine if there is a connection between postoperative infection parameters and intraoperative renal oxygenation measurements.
Read the detailed description
The study will involve ASA class I-III pediatric patients aged 1-18 undergoing RIRS, URS, and hypospadias surgery under general anesthesia. Patients will be divided into three groups: Group R (RIRS), Group U (URS), and Group H (Hypospadias/Control). Data collection will include patient height and weight. In Groups R and U, pre- and postoperative measurements such as hemoglobin, hematocrit, leukocyte count, BUN, serum creatinine, procalcitonin, interleukin-6, and CRP values will be recorded.
All three groups will undergo NIRS monitoring alongside routine ASA monitoring. Renal NIRS probes will be positioned using ultrasonography, and the average of three measurements will determine the regional oxygen saturation index (rSO2) as the initial value. NIRS, pulse oximetry, and hemodynamic data will be recorded every 5 minutes until recovery from anesthesia just prior to induction. A decrease of 20% or more than 20% when comparing NIRS values during follow-up with the baseline will be considered significant. The study will also document anesthesia and surgery times, as well as postoperative fever and the amount of irrigation fluid used in Groups R and U.
- Conditions
- Renal Stone, Kidney; Complications, Ureter Stone, Renal Oxygenation
- Being tested
- NIRS, Taking a blood sample
- Keywords
- Near infrared spectroscopy, Pediatric, Renal oxygenation, Endourologic stone surgery, infectious complication
- Medical subject headings
- Nephrolithiasis, Ureterolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NIRSDevice
After the positions of the renal NIRS probes are confirmed by ultrasonography, the average value of the three measurements will be taken and the regional oxygen saturation index (rSO2) will be accepted as the initial value.
Taking a blood sampleOther
Pre- and Postoperative hemoglobin (Hb), hematocrit (Htc), leukocyte (WBC), blood urea nitrogen (BUN), serum creatinine (sCr), procalcitonin, interleukin-6 and CRP values will be recorded.
| Study group | Role | What they receive |
|---|---|---|
| Group R | Pre- and Postoperative hemoglobin (Hb), hematocrit (Htc), leukocyte (WBC), blood urea nitrogen (BUN), serum creatinine (sCr), procalcitonin, interleukin-6 and CRP values will be recorded. NIRS monitoring will be performed in addition to routine ASA monitoring. After the positions of the renal NIRS probes are confirmed by ultrasonography, the average value of the three measurements will be taken and the regional oxygen saturation index (rSO2) will be accepted as the initial value. NIRS, pulse oximetry, and hemodynamic data will be recorded every 5 minutes until recovery from anesthesia just prior to induction. When comparing the NIRS values measured during follow-up with the baseline NIRS value, a decrease of 20% or more than 20% will be considered significant. Anesthesia and surgery times will also be recorded. Postoperative fever and the amount of irrigation fluid used during the surgical procedure will be recorded . Receives: Device: NIRS; Other: Taking a blood sample | |
| Group U | Pre- and Postoperative hemoglobin (Hb), hematocrit (Htc), leukocyte (WBC), blood urea nitrogen (BUN), serum creatinine (sCr), procalcitonin, interleukin-6 and CRP values will be recorded. NIRS monitoring will be performed in addition to routine ASA monitoring. After the positions of the renal NIRS probes are confirmed by ultrasonography, the average value of the three measurements will be taken and the regional oxygen saturation index (rSO2) will be accepted as the initial value. NIRS, pulse oximetry, and hemodynamic data will be recorded every 5 minutes until recovery from anesthesia just prior to induction. When comparing the NIRS values measured during follow-up with the baseline NIRS value, a decrease of 20% or more than 20% will be considered significant. Anesthesia and surgery times will also be recorded. Postoperative fever and the amount of irrigation fluid used during the surgical procedure will be recorded . Receives: Device: NIRS; Other: Taking a blood sample | |
| Group H | The study involves continuous NIRS monitoring in addition to routine ASA monitoring. To establish the initial value of regional oxygen saturation (rSO2), renal NIRS probes will be positioned using ultrasonography, and an average of three measurements will be taken. Throughout the procedure, NIRS data, along with pulse oximetry and hemodynamic data, will be recorded at 5-minute intervals until the patient recovers from anesthesia just prior to induction. Significant changes in NIRS values will be determined if a decrease of 20% or more compared to the baseline measurement is observed. Anesthesia and surgery times will also be recorded. Receives: Device: NIRS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Near infrared spectroscopy (NIRS)
Rretrograde intrarenal surgery (RIRS), ureteroscopy (URS) and hypospadias operations, renal oxygen level will be measured via NIRS monitor.
Measured: NIRS values will be documented immediately prior to induction and every 5 minutes until recovery from anesthesia.
Secondary outcomes (3)
Infection parameters
Procalcitonin
Measured: Preoperative and postoperative 24th hour
Infection parameters
Interleukin-6
Measured: Preoperative and postoperative 24th hour
Infection parameters
C-reactive protein (CRP)
Measured: Preoperative and postoperative 24th hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2023
- Study start3 Nov 2023
- Primary completion7 Mar 2024
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal StoneStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 136 participants (actual)
- Target duration
- 2 Days
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Şengül Özmert, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06110247
- Sponsor's protocol ID
- NIRS
- Status last verified
- Jul 2024
- First submitted
- 26 Oct 2023
- Last updated
- 30 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Renal Oxygenation in Pediatric Retrograde Intrarenal Surgery (RIRS) and Ureteroscopy (URS) Procedures by Near Infrared Spectroscopy (NIRS)
- ClinicalTrials.gov ID
- NCT06110247
- Acronym / sponsor ID
- NIRS
- Conditions
- Renal Stone, Kidney; Complications, Ureter Stone, Renal Oxygenation
- Keywords
- Near infrared spectroscopy, Pediatric, Renal oxygenation, Endourologic stone surgery, infectious complication
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 3 Nov 2023 (actual)
- Primary completion
- 7 Mar 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 31 Oct 2023 (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.
The study aims to compare renal oxygenation levels in retrograde intrarenal surgery (RIRS) and ureteroscopy (URS) procedures with a control group. Additionally, it seeks to determine if there is a connection between postoperative infection parameters and intraoperative renal oxygenation measurements.
Detailed description
The study will involve ASA class I-III pediatric patients aged 1-18 undergoing RIRS, URS, and hypospadias surgery under general anesthesia. Patients will be divided into three groups: Group R (RIRS), Group U (URS), and Group H (Hypospadias/Control). Data collection will include patient height and weight. In Groups R and U, pre- and postoperative measurements such as hemoglobin, hematocrit, leukocyte count, BUN, serum creatinine, procalcitonin, interleukin-6, and CRP values will be recorded.
All three groups will undergo NIRS monitoring alongside routine ASA monitoring. Renal NIRS probes will be positioned using ultrasonography, and the average of three measurements will determine the regional oxygen saturation index (rSO2) as the initial value. NIRS, pulse oximetry, and hemodynamic data will be recorded every 5 minutes until recovery from anesthesia just prior to induction. A decrease of 20% or more than 20% when comparing NIRS values during follow-up with the baseline will be considered significant. The study will also document anesthesia and surgery times, as well as postoperative fever and the amount of irrigation fluid used in Groups R and U.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 2 Days
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group R | – | Device: NIRS, Other: Taking a blood samplePre- and Postoperative hemoglobin (Hb), hematocrit (Htc), leukocyte (WBC), blood urea nitrogen (BUN), serum creatinine (sCr), procalcitonin, interleukin-6 and CRP values will be recorded. NIRS monitoring will be performed in addition to routine ASA monitoring. After the positions of the renal NIRS probes are confirmed by ultrasonography, the average value of the three measurements will be taken and the regional oxygen saturation index (rSO2) will be accepted as the initial value. NIRS, pulse oximetry, and hemodynamic data will be recorded every 5 minutes until recovery from anesthesia just prior to induction. When comparing the NIRS values measured during follow-up with the baseline NIRS value, a decrease of 20% or more than 20% will be considered significant. Anesthesia and surgery times will also be recorded. Postoperative fever and the amount of irrigation fluid used during the surgical procedure will be recorded . |
| Group U | – | Device: NIRS, Other: Taking a blood samplePre- and Postoperative hemoglobin (Hb), hematocrit (Htc), leukocyte (WBC), blood urea nitrogen (BUN), serum creatinine (sCr), procalcitonin, interleukin-6 and CRP values will be recorded. NIRS monitoring will be performed in addition to routine ASA monitoring. After the positions of the renal NIRS probes are confirmed by ultrasonography, the average value of the three measurements will be taken and the regional oxygen saturation index (rSO2) will be accepted as the initial value. NIRS, pulse oximetry, and hemodynamic data will be recorded every 5 minutes until recovery from anesthesia just prior to induction. When comparing the NIRS values measured during follow-up with the baseline NIRS value, a decrease of 20% or more than 20% will be considered significant. Anesthesia and surgery times will also be recorded. Postoperative fever and the amount of irrigation fluid used during the surgical procedure will be recorded . |
| Group H | – | Device: NIRSThe study involves continuous NIRS monitoring in addition to routine ASA monitoring. To establish the initial value of regional oxygen saturation (rSO2), renal NIRS probes will be positioned using ultrasonography, and an average of three measurements will be taken. Throughout the procedure, NIRS data, along with pulse oximetry and hemodynamic data, will be recorded at 5-minute intervals until the patient recovers from anesthesia just prior to induction. Significant changes in NIRS values will be determined if a decrease of 20% or more compared to the baseline measurement is observed. Anesthesia and surgery times will also be recorded. |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- ASA I-III class between the ages of 1-18, patients who will undergo RIRS and URS surgery under standard general anesthesia, as well as patients who will undergo hypospadias surgery (without a history of stones or kidney problems).
Key inclusion criteria (3 listed)
- 1-18 years ASA I-III class,
- Patients who will undergo RIRS, URS and Hypospadias surgeries under standard general anesthesia.
- Patients whose informed consent form is approved by their parents will be included in the study.
Key exclusion criteria (2 listed)
- Exclusio criteria were the history of renal failure, renal tumors, infection of the perirenal region; receiving colloid or blood transfusion, having abscess, body mass index (BMI) not in the normal limits (≤3% or ≥97%)
- Patients whose parents do not approve the informed consent form will not be included in the study.
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 |
|---|---|---|
| NIRSAfter the positions of the renal NIRS probes are confirmed by ultrasonography, the average value of the three measurements will be taken and the regional oxygen saturation index (rSO2) will be accepted as the initial value. | Device | Group H, Group R, Group U |
| Taking a blood samplePre- and Postoperative hemoglobin (Hb), hematocrit (Htc), leukocyte (WBC), blood urea nitrogen (BUN), serum creatinine (sCr), procalcitonin, interleukin-6 and CRP values will be recorded. | Other | Group R, Group U |
Primary outcome
Near infrared spectroscopy (NIRS)
Time frame: NIRS values will be documented immediately prior to induction and every 5 minutes until recovery from anesthesia.
Rretrograde intrarenal surgery (RIRS), ureteroscopy (URS) and hypospadias operations, renal oxygen level will be measured via NIRS monitor.
3 secondary outcomes
Infection parameters
Time frame: Preoperative and postoperative 24th hour
Infection parameters
Time frame: Preoperative and postoperative 24th hour
Infection parameters
Time frame: Preoperative and postoperative 24th hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2024.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Renal Stone and Kidney; Complications, run by Ankara City Hospital Bilkent 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 3 inclusion and 2 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: finished, as of the sponsor's last update on 30 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Near infrared spectroscopy (NIRS) (time frame: NIRS values will be documented immediately prior to induction and every 5 minutes until recovery from anesthesia.). 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 30 Jul 2024.