Using the Speckle Doppler to Quantify Blood Flow in Kidney and Pancreas Grafts

NCT04202237 | Completed

• 1 other identifier: B00075
• Study Type: observational
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

Kidney and Pancreas transplantation is considered the treatment of choice for many people with End Stage Renal Disease and Type 1 diabetes because quality of life and survival is often better after transplantation. However the quality of organs varies as does the quality of perfusion once they are transplanted. The immediate determinant of the survival of any transplanted allograft often depends on the overall quality of perfusion of the organ. The assessment of perfusion is currently visually and empirically done and reported by the surgical team, with low objectivity. The Laser Speckle Doppler technique will be used in both kidney and pancreas transplantation to objectively study the quality of blood flow to the kidney and pancreas after transplantation. This Doppler will provide continuous, non-invasive blood flow monitoring of the microvascular environment of the transplanted organ. The strength of the technique is in evaluating changes in flow over an area of interest or the whole transplanted organ and accurately numerically quantifying the flow. The laser speckle Doppler technique is now well established and has been used in various clinical and research setting as the most convenient means of assessing tissue blood flow. It has however not yet been used in kidney and pancreas transplantation.

Conditions

Kidney Transplant Failure and Rejection

Outcome Measures

Primary Outcomes (1)

• To evaluate the use of the laser blood flow imager in both kidney and pancreas transplantation

  Doppler imaging of kidneys and pancreas

  3 months

Secondary Outcomes (1)

• Measure the markers of inflammation ng/ml Hypo perfusion and oxidative stress (ng/ml) and attempt correlation with the quality of perfusion obtained

  6-12 months

Interventions

Speckle Doppler imaging OTHER

Speckle Doppler Laser imaging

Also known as: Laser Imaging

Blood sample OTHER

Blood sampling

Also known as: Venepuncture

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study plans to recruit all recipients of, both kidney and pancreas transplants within a 14-week course of the study (Period of Lease of the Speckle Laser Doppler). It is expected that approximately n=60 kidney transplants (Living Donor, DBD and DCD and Marginal Kidneys) and n=8 pancreas transplant patients will be recruited in this study period. This will provide a range of grafts of varying quality of perfusion for assessment

You may qualify if:

• Kidney Transplant Recipients
• Age between 18 and 75 years
• English Speaking as no funding for translators available
• Able to provide written informed consent
• Receiving a kidney transplant at Manchester University NHS Foundation Trust
• Pancreas Transplant Recipients
• Age between 18 and 75 years
• English Speaking as no funding for translators available

You may not qualify if:

• Outside of stated age range. Aged 76+

Sponsors & Collaborators

• Manchester University NHS Foundation Trust: lead

Study Sites (1)

Manchester University NHS Foundationn Trust

Manchester, Greater Manchester, M13 9WL, United Kingdom

Location

Related Publications (1)

• Gopal JP, Vaz O, Varley R, Spiers H, Goldsworthy MA, Siddagangaiah V, Lock B, Sharma V, Summers A, Moinuddin Z, van Dellen D, Augustine T. Using Laser Speckle Contrast Imaging to Quantify Perfusion Quality in Kidney and Pancreas Grafts on Vascular Reperfusion: A Proof-of-Principle Study. Transplant Direct. 2023 Apr 19;9(5):e1472. doi: 10.1097/TXD.0000000000001472. eCollection 2023 May.

  PMID: 37090123 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Plasma and cell pellets following blood centrifugation will be collected and stored.

MeSH Terms

Conditions

Rejection, Psychology

Interventions

Laser Speckle Contrast Imaging; Blood Specimen Collection

Condition Hierarchy (Ancestors)

Social Behavior; Behavior

Intervention Hierarchy (Ancestors)

Optical Imaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Specimen Handling; Clinical Laboratory Techniques; Punctures; Surgical Procedures, Operative

Study Officials

• Titus Augustine, FRCS

  Manchester university foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2019
• First Posted: December 17, 2019
• Study Start: December 6, 2019
• Primary Completion: July 30, 2021
• Study Completion: July 30, 2021
• Last Updated: October 5, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)