Postoperative Renal FunctionNCT07753434
Intraoperative Laser Speckle Imaging Predicts Early Renal Function After Kidney Transplantation
An observational study of Postoperative Renal Function, run by The Second Affiliated Hospital of Chongqing Medical University at 1 site in China.
Trial summary
This observational study aims to explore the predictive value of intraoperative laser speckle contrast imaging for early postoperative renal function in kidney transplant recipients. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Postoperative Renal Function
- What is being tested?
- laser speckle contrast imaging (LSCI)
- Type of treatment
- Medical device
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2024to 27 Feb 2025
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who underwent renal transplantation at our hospital between August 2024 and February 2025.
Who may be able to join
- Patients undergoing renal transplantation in our hospital.
Who cannot join
- Patients who need reoperation within 7 days after initial renal transplantation.
- Patients with acute rejection within 24 hours after operation.
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400010
About this study
Official title: An Observational Study on the Predictive Value of Intraoperative Laser Speckle Contrast Imaging for Early Postoperative Renal Function in Kidney Transplant Recipients
This observational study aims to explore the predictive value of intraoperative laser speckle contrast imaging for early postoperative renal function in kidney transplant recipients. The core research question is: What is the efficacy of intraoperative laser speckle contrast imaging in predicting early postoperative renal function among kidney transplant patients? This study will enroll kidney transplant patients who undergo intraoperative laser speckle contrast imaging and collect relevant evaluation data.
Last updated on February 27, 2025
- Conditions
- Postoperative Renal Function
- Being tested
- laser speckle contrast imaging (LSCI)
- Keywords
- postoperative renal function, laser speckle contrast imaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laser speckle contrast imaging (LSCI)Device
Before abdominal closure, renal microcirculation was assessed using the RFLSI-ZW laser speckle contrast imaging (LSCI) system (RWD Life Science) which was mounted on a portable stand. The device was positioned 15-30 cm above the transplanted kidney, with the speckle lens aligned to the graft surface. Automatic focusing was applied to optimize image clarity, and images of the upper pole of the kidney were captured within a 15 × 15 cm field of view. 60 seconds of microcirculation imaging and perfusion curves were recorded at the upper pole of the kidney after reperfusion and immediately prior to abdominal closure (Figure 1). Perfusion Index (PI) was calculated using the software of the RFLSI-ZW LSCI system, which was closely related to the product of mean erythrocyte flow velocity and concentration within the tissue.
What is being measured
The primary outcome is the main question the study is designed to answer.
Slow graft function (SGF)
Measured: Within 7 days after renal transplantation
Secondary outcomes (5)
Postoperative Cr
Measured: Within the first 7 postoperative days
Postoperative BUN
Measured: Within the first 7 postoperative days
Postoperative UO
Measured: Within the first 7 postoperative days
Postoperative eGFR
Measured: Within the first 7 postoperative days
Hospital length of stay
The total length of hospital stay after renal transplantation.
Measured: Up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2026
- Study start1 Aug 2024
- Primary completion1 Feb 2025
- Study completion27 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Renal FunctionStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Second Affiliated Hospital of Chongqing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guangyou Duan, The Second Affiliated Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07753434
- Sponsor's protocol ID
- NO.2024-125
- Status last verified
- Aug 2026
- First submitted
- 1 Aug 2026
- Last updated
- 7 Aug 2026
- Results posted
- 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 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study on the Predictive Value of Intraoperative Laser Speckle Contrast Imaging for Early Postoperative Renal Function in Kidney Transplant Recipients
- ClinicalTrials.gov ID
- NCT07753434
- Acronym / sponsor ID
- NO.2024-125
- Conditions
- Postoperative Renal Function
- Keywords
- postoperative renal function, laser speckle contrast imaging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- The Second Affiliated Hospital of Chongqing Medical UniversityUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 1 Feb 2025 (actual)
- Study completion
- 27 Feb 2025 (actual)
- First posted
- 7 Aug 2026 (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.
This observational study aims to explore the predictive value of intraoperative laser speckle contrast imaging for early postoperative renal function in kidney transplant recipients. The core research question is: What is the efficacy of intraoperative laser speckle contrast imaging in predicting early postoperative renal function among kidney transplant patients? This study will enroll kidney transplant patients who undergo intraoperative laser speckle contrast imaging and collect relevant evaluation data.
Last updated on February 27, 2025
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who underwent renal transplantation at our hospital between August 2024 and February 2025.
Key inclusion criteria (1 listed)
- Patients undergoing renal transplantation in our hospital.
Key exclusion criteria (2 listed)
- Patients who need reoperation within 7 days after initial renal transplantation.
- Patients with acute rejection within 24 hours after operation.
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 |
|---|---|---|
| laser speckle contrast imaging (LSCI)Before abdominal closure, renal microcirculation was assessed using the RFLSI-ZW laser speckle contrast imaging (LSCI) system (RWD Life Science) which was mounted on a portable stand. The device was positioned 15-30 cm above the transplanted kidney, with the speckle lens aligned to the graft surface. Automatic focusing was applied to optimize image clarity, and images of the upper pole of the kidney were captured within a 15 × 15 cm field of view. 60 seconds of microcirculation imaging and perfusion curves were recorded at the upper pole of the kidney after reperfusion and immediately prior to abdominal closure (Figure 1). Perfusion Index (PI) was calculated using the software of the RFLSI-ZW LSCI system, which was closely related to the product of mean erythrocyte flow velocity and concentration within the tissue. | Device | – |
Primary outcome
Slow graft function (SGF)
Time frame: Within 7 days after renal transplantation
5 secondary outcomes
Postoperative Cr
Time frame: Within the first 7 postoperative days
Postoperative BUN
Time frame: Within the first 7 postoperative days
Postoperative UO
Time frame: Within the first 7 postoperative days
Postoperative eGFR
Time frame: Within the first 7 postoperative days
Hospital length of stay
Time frame: Up to 12 weeks
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 7 Aug 2026.
- 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 Postoperative Renal Function, run by The Second Affiliated Hospital of Chongqing Medical University at 1 site in China.
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 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 7 Aug 2026. 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 China. 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?
Slow graft function (SGF) (time frame: Within 7 days after renal transplantation). 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 7 Aug 2026.