Evaluation of hydration and bicarbonate to prevent acute renal injury after endovascular aneurysm repair (EVAR)

Not Applicable

Completed

• Conditions: Specialty: Cardiovascular disease, Primary sub-specialty: Cardiac surgery; UKCRC code/ Disease: Renal/ Other disorders of kidney and ureter; Urological and Genital Diseases; Acute kidney injury following EVAR

• Registration Number: ISRCTN12291961
• Lead Sponsor: niversity of Leicester

Brief Summary

2018 Results article in https://pubmed.ncbi.nlm.nih.gov/29482973/ (added 10/03/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-09-29
• Study Completion: 2017-05-30
• Last Update Posted: 21 March 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 58

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
11. Surgery within 1 month before EVAR
12. Major trauma within 1 month before EVAR
13. Established metabolic or respiratory alkalosis 14. Patient receiving chemotherapy, radiotherapy or steroid therapy
15. Life expectancy less than 1 year
16. Patient undergoing renal dialysis for established renal failure
17. Patient receiving nephrotoxic medication for 48 hours prior to EVAR
18. Patient unwilling or unable to provide informed consent
19. Participation in other interventional clinical trial 1 month prior to commencing HYDRA-P
20. Established pulmonary oedema at baseline
21. Hyperventilation
22. Hypernatraemia
23. Systolic blood pressure exceeding 200mHg at baseline
24. Unable to understand and provide consent in English

Study & Design

• Study Type: Interventional
• Study Design: Not specified