Acute Kidney Injury Clinical Trial
— Re-DUCE-FOfficial title:
Preconditioning Against Renal Damage Under Contrast Examination: a Single Centre, Randomized, Sham -Controlled Clinical Feasibility Trial
This study aims to assess if applying an ischaemic insult to an arm before giving
intravenous contrast will help decrease the incidence of developing contrast induced acute
renal injury in patients undergoing contrast-enhanced CT Scans.
The main research question is 'In adult in-patients undergoing contrast-enhanced CT scans,
does remote ischaemic pre-conditioning (RIPC) induced by brief arm ischaemia and
reperfusion, when compared to control, reduce the proportion of patients developing
contrast-induced acute kidney injury in the first 3 post-scan days? '.
Status | Recruiting |
Enrollment | 1000 |
Est. completion date | June 2015 |
Est. primary completion date | April 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - All medical and surgical in-patients aged 40-yrs or over scheduled to undergo contrast-enhanced CT scans. - Patients willing to give full informed consent for participation Exclusion Criteria: - Pregnancy - Significant upper limb peripheral arterial disease - Previous history of upper limb deep vein thrombosis - Patients on glibenclamide or nicorandil (these medications may interfere with RIPC) - Patients with an estimated pre-operative glomerular filtration rate <30mls/min/1.73m2 - Patients with a known history of myocarditis, pericarditis or amyloidosis - Patients who have received intravenous contrast in the previous year - Patients with severe hepatic disease defined as a an international normalised ratio >2 in the absence of systemic anticoagulation - Patients previously enrolled in the trial representing a further scan |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Ireland | University Hospital Limerick | Limerick |
Lead Sponsor | Collaborator |
---|---|
Mid Western Regional Hospital, Ireland |
Ireland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Reduction in estimated glomerular filtration rate(eGFR) using RIPC | Our primary research objective is to determine whether RIPC induced using brief arm ischaemia and reperfusion reduces the proportion of patients who develop a reduction in estimated glomerular filtration rate(eGFR) =20% in the first 3 days following CT scan | 3 days post scan | No |
Secondary | Length of hospital stay | To determine whether RIPC reduces length of hospital stay | 30 days | No |
Secondary | Length of intensive care stay | To determine whether RIPC reduces ITU stay | 30 days | No |
Secondary | Numbers of unplanned critical care admissions | To determine whether RIPC reduces unplanned critical care admission | 30 days | No |
Secondary | Renal impariment after 1 year | To determine the proportion of patients who develop renal impairment within 1 year of ce-CT | 1 year | No |
Secondary | Recruitment potential for phase 3 study | To evaluate the likely recruitment rates for a phase 3 trial | 15 months | No |
Secondary | Acceptability of intervention | To examine the acceptability of the intervention to clinicians and patients utilising qualitative methods | 30 days | No |
Secondary | Cost effectiveness | To evaluate the cost-effectiveness of RIPC in the prevention of CI-AKI in patients undergoing ce-CT | 1 year | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05538351 -
A Study to Support the Development of the Enhanced Fluid Assessment Tool for Patients With Acute Kidney Injury
|
||
Recruiting |
NCT06027788 -
CTSN Embolic Protection Trial
|
N/A | |
Completed |
NCT03938038 -
Guidance of Ultrasound in Intensive Care to Direct Euvolemia
|
N/A | |
Recruiting |
NCT05805709 -
A Patient-centered Trial of a Process-of-care Intervention in Hospitalized AKI Patients: the COPE-AKI Trial
|
N/A | |
Recruiting |
NCT05318196 -
Molecular Prediction of Development, Progression or Complications of Kidney, Immune or Transplantation-related Diseases
|
||
Recruiting |
NCT05897840 -
Continuous Central Venous Oxygen Saturation Measurement as a Tool to Predict Hemodynamic Instability Related to Renal Replacement Therapy in Critically Ill Patients
|
N/A | |
Recruiting |
NCT04986137 -
Fractional Excretion of Urea for the Differential Diagnosis of Acute Kidney Injury in Cirrhosis
|
||
Terminated |
NCT04293744 -
Acute Kidney Injury After Cardiac Surgery
|
N/A | |
Completed |
NCT04095143 -
Ultrasound Markers of Organ Congestion in Severe Acute Kidney Injury
|
||
Not yet recruiting |
NCT06026592 -
Detection of Plasma DNA of Renal Origin in Kidney Transplant Patients
|
||
Not yet recruiting |
NCT06064305 -
Transcriptional and Proteomic Analysis of Acute Kidney Injury
|
||
Terminated |
NCT03438877 -
Intensive Versus Regular Dosage For PD In AKI.
|
N/A | |
Terminated |
NCT03305549 -
Recovery After Dialysis-Requiring Acute Kidney Injury
|
N/A | |
Completed |
NCT05990660 -
Renal Assist Device (RAD) for Patients With Renal Insufficiency Undergoing Cardiac Surgery
|
N/A | |
Completed |
NCT04062994 -
A Clinical Decision Support Trial to Reduce Intraoperative Hypotension
|
||
Terminated |
NCT02860130 -
Clinical Evaluation of Use of Prismocitrate 18 in Patients Undergoing Acute Continuous Renal Replacement Therapy (CRRT)
|
Phase 3 | |
Completed |
NCT06000098 -
Consol Time and Acute Kidney Injury in Robotic-assisted Prostatectomy
|
||
Not yet recruiting |
NCT05548725 -
Relation Between Acute Kidney Injury and Mineral Bone Disease
|
||
Completed |
NCT02665377 -
Prevention of Akute Kidney Injury, Hearttransplant, ANP
|
Phase 3 | |
Terminated |
NCT03539861 -
Immunomodulatory Biomimetic Device to Treat Myocardial Stunning in End-stage Renal Disease Patients
|
N/A |