Preliminary study assessing how renal damage can be prevented in aneurysm surgery

Phase 1

• Conditions: Acute kidney injury post endovascular repair of the abdominal aortic aneurysm.; MedDRA version: 20.0 Level: PT Classification code 10069339 Term: Acute kidney injury System Organ Class: 10038359 - Renal and urinary disorders; MedDRA version: 20.0 Level: LLT Classification code 10068736 Term: Acute oliguric renal failure System Organ Class: 10038359 - Renal and urinary disorders; MedDRA version: 20.1 Level: LLT Classification code 10001041 Term: Acute renal failure System Organ Class: 10038359 - Renal and urinary disorders; MedDRA version: 20.0 Level: LLT Classification code 10068736 Term: Acute oliguric renal failure System Organ Class: 10038359 - Renal and urinary disorder; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]; MedDRA version: 20.0 Level: LLT Classification code 10000051 Term: Abdominal aneurysm System Organ Class: 100000004866; MedDRA version: 20.0 Level: LLT Classification code 10001051 Term: Acute renal failure, unspecified System Organ Class: 10038359 - Renal and urinary disorders; MedDRA version: 20.0 Level: LLT Classification code 10000054 Term: Abdominal aortic aneurysm System Organ Class: 100000004866; MedDRA version: 20.0 Level: LLT Classification code 10070787 Term: Anuric renal failure System Organ Class: 10038359 - Renal and urinary disorders

• Registration Number: EUCTR2015-003073-15-GB
• Lead Sponsor: Research Governance, University of Leicester

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-15
• Last Update Posted: 30 April 2019
• Study Completion: 2019-09-16

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 58

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
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 clinical trial of medicinal product
• Study Design: Not specified