Continuous Implantable Doppler probe monitoring in renal transplant
Research type
Research Study
Full title
The role of an implantable Doppler vascular monitoring device in kidney transplant patients: a feasibility randomised controlled trial with an embedded qualitative study.
IRAS ID
302833
Contact name
M Shahzar Malik
Contact email
Sponsor organisation
University Hospital Plymouth NHS Trust
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
Summary of Research
Vascular complications (VC) account for 30-35% of the total kidney grafts lost during the first three months after implantation. A vascular monitoring device (VMD) may have a possible role in early identification of VC critical to reduce graft loss.
This study aims to evaluate the feasibility of VMD in kidney transplant surgery (feasibility of the intervention) and by obtaining the vital information, to inform the protocol development of a definitive multi-centre RCT (feasibility of conducting the future trial).
A mixed methodology: Feasibility randomised controlled trial with an embedded qualitative study will be conducted at the Southwest Transplant centre, UHPNT.
Total participants (n=50) will be randomised equally into Intervention (n=25) and Control (n=25) Groups depending on if they will have kidney transplant with or without the VMD. Both the groups will be followed up at 24, 48, and 72 hours postoperatively in the ward and at the three-monthly clinic visit.
The participant’s demographical characteristics and surgical outcomes in each group will be summarized and compared using descriptive statistics. Qualitative interviews of stakeholder (n=12) will be conducted to explore their experiences and suggestions of participating in the study.
Information related to the assessment of the scientific basis, research processes, acceptability, resources, and management will also be compiled to generate realistic estimates of important parameters for the future research.
Favourable results will lead to the implementation of VMD in local practice and inform the main trial that is planned in collaboration with other transplant centres in the UK.
It is anticipated that this study will elaborate on the possible role of VMD to improve patient safety, increase graft survival, advance service quality improvement, and increase financial savings in the NHS.Summary of Results
Vascular thrombosis is a disastrous postoperative complication resulting in the loss of 3.5% to 5.7% of all kidney transplants. The use of novel blood flow-sensing technology in the early postoperative period may allow loss of vascular patency or thrombosis to be detected immediately, which is critical in reducing thrombosis-related graft loss. An implantable Doppler probe utilises blood flow sensing technology to provide continuous feedback on blood flow when connected to a vascular anastomosis. This clinical research aimed to assess the theoretical basis and feasibility of an implantable Doppler probe as a blood flow-monitoring device in kidney transplant recipients and to evaluate its usefulness in preventing early graft loss. The Medical Research Council's (MRC) framework for developing and evaluating complex interventions in clinical settings was followed. Step 1. Development, Step 2: Feasibility, Step 3: Evaluation, and Step 4: Implementation. This research comprised an order of studies with different designs that were undertaken to address the above steps (i.e. literature review, retrospective cohort study, instructive case reports in the specialist area, descriptive-analytical cross-sectional study, patient-public involvement consultation (pre-trial), feasibility randomised controlled trial, embedded qualitative study (post-trial), and a systematic review). The results revealed that Blood flow sensing technology may be used as a beneficial adjunct for graft monitoring after kidney transplants. This preliminary research fills gaps in the evidence and will inform future research. Patient involvement in the study provided valuable insights for developing an intervention that could improve the postoperative care of kidney transplant patients and enhance their overall outcomes and experience. This research represents a significant effort to expand our understanding of the potential benefits of blood flow sensing technology in kidney transplantation. A pragmatic large-scale randomised controlled trial is warranted to evaluate the effectiveness of implantable Doppler probes in clinical practice.REC name
North of Scotland Research Ethics Committee 1
REC reference
22/NS/0009
Date of REC Opinion
29 Jan 2022
REC opinion
Favourable Opinion