ISRCTN12291961
Completed
未知
HYDration and bicarbonate to prevent acute Renal injury after endovascular Aneurysm repair: pilot-feasibility randomized controlled study (HYDRA pilot trial)
niversity of Leicester0 sites58 target enrollmentSeptember 29, 2016
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- niversity of Leicester
- Enrollment
- 58
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
2018 Results article in https://pubmed.ncbi.nlm.nih.gov/29482973/ (added 10/03/2022)
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Those undergoing an elective endovascular infra\-renal abdominal aortic aneurysm repair, for a non\-ruptured or leaking aneurysm
- •2\. Aged 18 years and over
- •3\. Able to provide informed consent for the EVAR and participation in the study
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
Active, not recruiting
Phase 1
Preliminary study assessing how renal damage can be prevented in aneurysm surgeryAcute 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]EUCTR2015-003073-15-GBResearch Governance, University of Leicester58
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