NCT07753434

Brief 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. 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2025

Completed
26 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 27, 2025

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

August 1, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 7, 2026

Completed
Last Updated

August 7, 2026

Status Verified

August 1, 2026

Enrollment Period

6 months

First QC Date

August 1, 2026

Last Update Submit

August 6, 2026

Conditions

Keywords

postoperative renal functionlaser speckle contrast imaging

Outcome Measures

Primary Outcomes (1)

  • Slow graft function (SGF)

    Within 7 days after renal transplantation

Secondary Outcomes (5)

  • Postoperative Cr

    Within the first 7 postoperative days

  • Postoperative BUN

    Within the first 7 postoperative days

  • Postoperative UO

    Within the first 7 postoperative days

  • Postoperative eGFR

    Within the first 7 postoperative days

  • Hospital length of stay

    Up to 12 weeks

Interventions

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.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who underwent renal transplantation at our hospital between August 2024 and February 2025.

You may qualify if:

  • Patients undergoing renal transplantation in our hospital.

You may not qualify if:

  • Patients who need reoperation within 7 days after initial renal transplantation.
  • Patients with acute rejection within 24 hours after operation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Second Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400010, China

Location

MeSH Terms

Interventions

Laser Speckle Contrast Imaging

Intervention Hierarchy (Ancestors)

Optical ImagingDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

August 1, 2026

First Posted

August 7, 2026

Study Start

August 1, 2024

Primary Completion

February 1, 2025

Study Completion

February 27, 2025

Last Updated

August 7, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Locations