EUCTR2015-003073-15-GB
Active, not recruiting
Phase 1
HYDration and bicarbonate to prevent acute Renal injury after endovascular Aneurysm repair: pilot-feasibility randomized controlled study (HYDRA pilot trial) - HYDRA-P
Research Governance, University of Leicester0 sites58 target enrollmentMarch 15, 2019
ConditionsAcute kidney injury post endovascular repair of the abdominal aortic aneurysm.MedDRA version: 20.0 Level: LLT Classification code 10000051 Term: Abdominal aneurysm System Organ Class: 100000004866MedDRA version: 20.0 Level: LLT Classification code 10000054 Term: Abdominal aortic aneurysm System Organ Class: 100000004866MedDRA version: 20.0 Level: PT Classification code 10069339 Term: Acute kidney injury System Organ Class: 10038359 - Renal and urinary disordersMedDRA version: 20.0 Level: LLT Classification code 10068736 Term: Acute oliguric renal failure System Organ Class: 10038359 - Renal and urinary disordersMedDRA version: 20.1 Level: LLT Classification code 10001041 Term: Acute renal failure System Organ Class: 10038359 - Renal and urinary disordersMedDRA version: 20.0 Level: LLT Classification code 10001051 Term: Acute renal failure, unspecified System Organ Class: 10038359 - Renal and urinary disordersMedDRA version: 20.0 Level: LLT Classification code 10070787 Term: Anuric renal failure System Organ Class: 10038359 - Renal and urinary disordersMedDRA version: 20.0 Level: LLT Classification code 10068736 Term: Acute oliguric renal failure System Organ Class: 10038359 - Renal and urinary disorderTherapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Acute kidney injury post endovascular repair of the abdominal aortic aneurysm.
- Sponsor
- Research Governance, University of Leicester
- Enrollment
- 58
- Status
- Active, not recruiting
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients who:
- •1\. Undergo an elective endovascular infra\-renal abdominal aortic aneurysm repair, for a non\-ruptured or leaking aneurysm
- •2\. Are above the age of 18 years
- •3\. Are able to provide informed consent for the EVAR and participation in the study.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 10
- •F.1\.3 Elderly (\>\=65 years) yes
- •F.1\.3\.1 Number of subjects for this age range 50
Exclusion Criteria
- •1\.Emergency abdominal aortic aneurysm repair
- •2\.Leaking or ruptured aneurysm
- •3\.Age\<18 years
- •4\.Established cardiac failure with functional status \>NYHA III (severe heart failure)
- •5\.Allergy to contrast medium or sodium bicarbonate
- •6\.Pregnancy or lactation (pregnancy test is standard practice at baseline)
- •7\.Juxtarenal or suprarenal aneurysm
- •8\.Solitary kidney
- •9\.Administration of intra\-venous or intra\-arterial contrast \<2 days prior to EVAR
- •10\.Previous open AAA or iliac aneurysm repair
Outcomes
Primary Outcomes
Not specified
Similar Trials
Completed
Not Applicable
Evaluation of hydration and bicarbonate to prevent acute renal injury after endovascular aneurysm repair (EVAR)ISRCTN12291961niversity of Leicester58
Unknown
Phase 4
Prevention of Contrast-Induced Nephropathy in Diabetic Patients With Undergoing Coronary AngiographyContrast Induced NephropathyNCT00950079CardioVascular Research Foundation, Korea368
Completed
Phase 3
Sodium Bicarbonate for Prevention of Contrast-Induced NephropathyRenal FailureNCT01172353Hospital Sao Lucas da PUCRS301
Unknown
Phase 3
Preventing Acute Renal Failure After Cardiac Surgery in High Risk Patients Using Sodium Bicarbonate TherapyKidney Failure, AcuteNCT00522756McGill University Health Centre/Research Institute of the McGill University Health Centre200
Recruiting
Not Applicable
Use of Sodium Bicarbonate As Prophylaxis for Kidney Damage in Patients with HeatstrokeHeat StrokeAcute Kidney InjuryAcute Kidney Injury Due to HypovolaemiaNCT06622525Hospital General de Mexicali1