The Role of an Implantable Doppler Vascular Monitoring Device in Kidney Transplant Patients: a Feasibility Randomised Controlled Trial With an Embedded Qualitative Study.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 60
- Locations
- 2
- Primary Endpoint
- OBJECTIVE 1: To assess the capability of vascular monitoring device in the early postoperative care of kidney transplant patients This objective will be achieved in the feasibility randomised controlled trial.
Study Overview
Brief Summary
INTRODUCTION Vascular complications in kidney transplantation constitute one-third of the early graft loss (EGL) that can be prevented by timely diagnosed cases. A vascular monitoring device may have a possible role in the early identification of graft hypoperfusion critical to reducing graft loss.
AIM To evaluate the feasibility of an Implantable Doppler probe as a vascular monitoring device in kidney transplant patients and by obtaining the vital information, inform the protocol development of a definitive RCT.
METHODS AND ANALYSIS A mixed-method research design is selected. The quantitative study will comprise a feasibility RCT (fRCT) that will compare demographical characteristics and surgical outcomes of patients that will undergo kidney transplant surgery with vascular monitoring device (intervention group, n=25) against those with standard care clinical observation (control group, n=25). Descriptive statistics will be used to summarise the results that will assess the vascular monitoring capability of implantable Doppler probe in the early postoperative period of kidney transplant patients. The results will provide estimates for surgical outcomes essential to inform the sample size calculation for the definitive study. Information related to the fluency of research methods, availability of research resources, management support, potential challenges faced during the fRCT will be compiled to generate realistic estimates of important parameters for the definitive study. The results will be following the CONSORT updated guidelines for reporting feasibility studies.
Qualitative semi-structured interviews of stakeholders (n=12) recruited by purposive sampling will be conducted to explore their experiences of participating in the study, acquire suggestions regarding application of implantable Doppler probe monitoring, and the post implantation patient care. All interviews will be audio-recorded with verbatim transcription. Data will be analysed following the six-phase guide to doing thematic analysis in the NVivo software. The results will be reported in accordance with the consolidated criteria for reporting qualitative research (COREQ) checklist.
IMPACT It is anticipated that this study will also elaborate on a possible role of implantable Doppler probe monitoring to improve kidney transplant patient safety, graft survival, service quality improvement, and financial savings in the NHS.
Detailed Description
AIM:
To evaluate the usefulness of an implantable continuous vascular monitoring device in kidney transplant surgery and to inform the protocol development of a definitive planned RCT.
OBJECTIVES
Feasibility RCT OBJECTIVE 1 To assess the capability of the implantable vascular monitoring device in the early postoperative period of kidney transplant patients.
OBJECTIVE 2 To assess the research methods used to compare vascular monitoring device with the standard care and to estimate surgical outcome measures essential to inform the sample size calculation for the definitive planned RCT.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Masking Description
Blinding of the participants (kidney transplant patients) to the outcome of the randomisation will not be possible due to the nature of the intervention. Similarly, the healthcare professionals (clinicians and nurses) taking care of the patients and collecting the data postoperatively cannot be blinded. However, the Southwest transplant team acts in the best interest of the kidney transplant patients and declares no conflict of interest with the device.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients who will have deceased or living kidney donor transplants
- •Patients aged 18 years or above.
- •Patients able and willing to comply with the trial requirements
Exclusion Criteria
- •Patients who will have a kidney transplant with more than two arteries (evident at the time of surgery).
- •Patients below 18 years of age.
- •Patients lacking capacity or unwilling to give consent.
Outcomes
Primary Outcomes
OBJECTIVE 1: To assess the capability of vascular monitoring device in the early postoperative care of kidney transplant patients This objective will be achieved in the feasibility randomised controlled trial.
Time Frame: 12 weeks
OUTCOME MEASURES FOR OBJECTIVE 1: The following outcomes in both the intervention and control groups will be recorded and compared to measure the objective 1. 1. The number of early vascular complications identified in each group (measured as numerical number i.e.,1,2,3 etc). 2. The number of departmental ultrasound scans requested in the first 24, 48, and 72 hours postoperatively in each participant (measured as numerical number i.e.,1,2,3 etc). 3. The number of grafts lost due to vascular complications in each group (measured as numerical number i.e.,1,2,3 etc).
OBJECTIVE 3: To assess the availability of research resources, management support, potential barriers and challenges for the definitive planned future RCT. This objective will be achieved in the feasibility randomised controlled trial.
Time Frame: 12 weeks
OUTCOME MEASURES FOR OBJECTIVE 3: The availability of the following research resources in this study will be recorded. Any shortcomings or non-availability of resources encountered will be highlighted. 1. Availability of participant documentation (i.e., participant information sheet, consent form, data collection sheet) (measured as a binary variable i.e., Yes or No). 2. Availability of medical equipment and healthcare staff in the host centre required to handle the number of participants and the research procedures (measured as a binary variable i.e., Yes or No). 3. Availability of technological capacity for communication and adequate software to randomise, record, process, and store research data (measured as a binary variable i.e., Yes or No). 4. Availability of management support for the research project and back up plans for any extenuating circumstances (measured as a binary variable i.e., Yes or No).
Objective 4: To assess the acceptability of the ID probe blood flow monitoring device in clinical practice and get suggestions for the definitive planned future RCT. This objective will be achieved by the embedded qualitative study
Time Frame: 12 weeks
OUTCOME MEASURES FOR OBJECTIVE 4: The acceptability of the intervention in clinical practice will be assessed by conducting the thematic analysis of the views and experiences of stake holders (clinicians, transplant surgeons, nurses, and kidney transplant patients with the experience of receiving/delivering the intervention and participating in the study) obtained by qualitative interviews with open ended questions. Furthermore, suggestions to improve the design of the definitive planned future RCT, functioning of the ID probe blood flow monitoring device, or any aspect of postoperative patient care will also be acquired.
OBJECTIVE 2: To assess the research methods used in this feasibility randomised for the definitive planned randomised controlled study This objective will be achieved in the feasibility randomised controlled trial.
Time Frame: 12 weeks
OUTCOME MEASURES FOR OBJECTIVE 2: The suitability of the following research processes used in the study will be estimated. Any difficulties or shortcomings encountered will be highlighted. 1. Difficulties encountered with eligibility criteria and recruitment process (measured as a binary variable i.e., Yes or No). 2. Difficulties encountered with randomisation or allocation concealment (measured as a binary variable i.e., Yes or No). 3. Difficulties encountered with retention/follow-up/compliance of participants (measured as a binary variable i.e., Yes or No). 4. Variation or fidelity encountered in the delivery of the intervention marked against a fidelity checklist (measured as a binary variable i.e., Yes or No)
Secondary Outcomes
No secondary outcomes reported