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

HYDration and bicarbonate to prevent acute Renal injury after endovascular Aneurysm repair: pilot-feasibility randomized controlled study (HYDRA pilot trial)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN12291961

Enrollment

Registered

2016-09-29

Start date

2016-04-01

Completion date

Unknown

Last updated

2022-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Specialty: Cardiovascular disease, Primary sub-specialty: Cardiac surgery

Interventions

Patients undergoing elective endovascular aneurysm repair (EVAR) will be randomised on a 1:1 basis using an online randomisation system (RRAMP) through the Oxford Surgical Interventions Trials Unit (O

Eligibility

Sex/Gender

All

Inclusion 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

Exclusion criteria: 1. Emergency abdominal aortic aneurysm repair 2. Leaking or ruptured aneurysm 3. AgeNYHA 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

Design outcomes

Primary

Measure	Time frame
Recruitment rate is recorded as the number of eligible participants who consent to take part in the study in the 12 month recruitment period.	—

Secondary

Measure	Time frame
Proportion of patients developing AKI within 48 hours after completion of EVAR, as determined by NICE guidelines and assessing serum creatinine levels using clinical observations and reviewing medical records.	—

Countries

England, United Kingdom

Contacts

Public ContactAthanasios Saratzis

as875@le.ac.uk+44 7831 418104

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026