Plain English Summary
Background and study aims
An abdominal aortic aneurysm (AAA) is a swelling (aneurysm) of the aorta (the main blood vessel that leads away from the heart, down through the abdomen to the rest of the body). In many people, AAAs get bigger overtime, which can eventually lead to rupture (bursting) and death if left untreated. Endovascular Abdominal aortic Aneurysm Repair (EVAR), a type of keyhole surgery, is currently the commonest treatment for patients with an AAA. During the procedure a plastic tube (stent-graft) is inserted through small incisions in the groin. In order to be able to perform this minimally invasive (keyhole) procedure, it is essential to administer a special dye called contrast so that the blood vessels in the abdomen and near the AAA can be seen clearly with the help of x-rays. This dye can however lead affect the function of the kidneys. A potential consequence of EVAR is the development of acute kidney injury (AKI, sudden, serious damage to the kidneys) in up to 20% of individuals. AKI negatively affects patients in a number of ways including prolonging hospital stay and influencing long-term kidney function. Previous studies looking at other types of surgery have shown it is possible to prevent kidney problems by giving the patient a lot of fluid and a blood-salt (called bicarbonate) through a vein before surgery. The aim of this study is to explore whether it is possible to recruit enough patients for the study and at whether hydration and bicarbonate can help prevent AKI in patients undergoing EVAR.
Who can participate?
Adults who are having EVAR surgery for a AAA.
What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group receive the current standard of care before their EVAR surgery, which involves receiving fluids for one hour before and for 12 hours after surgery. Those in the second group also receive standard fluid treatment as well as being given a high dose of bicarbonate immediately before their EVAR starts. Participants in both groups undergo the EVAR as per standard practice and receive usual follow up care. Participants are monitored for 48 hours after surgery to look for signs of AKI. In addition, participants are seen after 30 days, to ensure no complications have arisen after the EVAR and participation in the study.
What are the possible benefits and risks of participating?
The only potential benefit of taking part in this study is that bicarbonate may prevent the risk of developing AKI after their EVAR however this is not provent. There are no other direct short term benefits. There is a slight risk that patients may develop an allergic reaction to the fluid or bicarbonate that is given. This is unlikely as the fluids used as part of the trial are fluids that are given to most patients having most types of surgery. Levels of blood salts and acids will be carefully monitored during the procedure and hospital stay.
Where is the study run from?
Leicester Royal Infirmary and University Hospitals Coventry & Warwickshire (UK)
When is the study starting and how long is it expected to run for?
February 2016 to May 2017
Who is funding the study?
Academy of Medical Sciences (UK)
Who is the main contact?
Mr Athanasios Saratzis
as875@le.ac.uk
Trial website
Contact information
Type
Public
Primary contact
Mr Athanasios Saratzis
ORCID ID
http://orcid.org/0000-0002-3399-094X
Contact details
Department of Cardiovascular Sciences & Leicester NIHR
Cardiovascular Biomedical Research Unit
University of Leicester
Robert Kilpatrick Building
Leicester Royal Infirmary
Leicester
LE1 5WW
United Kingdom
+44 7831 418104
as875@le.ac.uk
Additional identifiers
EudraCT number
2015-003073-15
ClinicalTrials.gov number
Protocol/serial number
30872
Study information
Scientific title
HYDration and bicarbonate to prevent acute Renal injury after endovascular Aneurysm repair: pilot-feasibility randomized controlled study (HYDRA pilot trial)
Acronym
HYDRA-P
Study hypothesis
The aim of this study is to:
1. Explore whether participants are willing to undergo treatment randomisation and, the readiness of clinicians to recruit patients in to studies, to inform for a larger randomised controlled trial
2. Assess whether hydration and bicarbonate administration can prevent AKI and renal damage in patients undergoing EVAR, and to determine if this could lead to an adoption in routine clinical practice
Ethics approval
East Midlands Central Research Ethics Committee, 12/02/2016, ref: 16/WM/0008
Study design
Randomised; Interventional; Design type: Prevention, Drug, Complex Intervention
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Specialty: Cardiovascular disease, Primary sub-specialty: Cardiac surgery; UKCRC code/ Disease: Renal/ Other disorders of kidney and ureter
Intervention
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 (Oxford SITU) following written informed consent for participation in the study prior to the EVAR. A simple randomisation method is used, given that this is a pilot randomised clinical trial. Following consent and randomisation, patients will then be allocated into one of two groups, an intervention or a control group.
Control group: Participants will receive the current NHS standard of care hydration method prior to EVAR which comprises of Hartmann’s solution 10mls/kg administered 1 hour prior to anaesthetic induction and a further 12 hours of intravenous hydration with Hartmann’s after the EVAR.
Intervention group: Together with the standardised hydration method, participants will receive an additional bolus dose of bicarbonate (1 mmol/kg or 1 ml/kg of an 8.4% solution) over 60 minutes, given at anaesthetic induction. During the procedure all participants will receive intra-operative fluids with the aim of maintaining mean arterial pressure within 80% of the baseline for 90% of the time. Post-operatively, 2mls/kg/hr of intravenous crystalloid will be given for 12 hours, identical to the control group.
All medication will be administered intravenously using a cannula and patient care will be overseen by an anaesthetist during the EVAR.
Urine and venous blood samples will be collected prior to surgery, during the EVAR procedure and post-surgery at 6, 24, 48 hours, day of discharge and finally at 30 days at the follow-up appointment. These samples will be used to measure serum creatinine, estimated GFR, subclinical urine markers, pH levels, bicarbonate levels and haemoglobin levels. Urine output of all patients will be recorded during the hospital stay up until they are discharged. The overall follow-up duration is 30 days (after the EVAR has taken place).
Intervention type
Other
Phase
Drug names
Primary outcome measure
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 outcome measures
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.
Overall trial start date
01/02/2016
Overall trial end date
30/05/2017
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 60; UK Sample Size: 60
Total final enrolment
58
Participant 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
Recruitment start date
01/04/2016
Recruitment end date
28/02/2017
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Leicester Royal Infirmary
Robert Kilpatrick Clinical Sciences Building
2nd Floor
Leicester
LE1 5WW
United Kingdom
Trial participating centre
University Hospitals Coventry & Warwickshire (UHCW)
Clifford Bridge Road
Coventry
CV2 2DX
United Kingdom
Funders
Funder type
Research organisation
Funder name
Academy of Medical Sciences
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
United Kingdom
Results and Publications
Publication and dissemination plan
The study will be presented at the Vascular Society of GB and Ireland Annual Meeting in 2018 as well as the Charing Cross Vascular Symposium held in London annually. The study will be completed in May 2017 and the results will be submitted for publication in a peer reviewed Journal within 2 months. Following completion of the pilot round (HYDRA-P) we will apply for funding in order to perform a national definitive study in multiple centres.
IPD Sharing plan:
The datasets generated during and/or analysed during the current study will be available upon request from the Oxford Surgical Interventions Trials Unit, when the study is complete.
Intention to publish date
01/07/2018
Participant level data
Available on request
Basic results (scientific)
https://www.clinicaltrialsregister.eu/ctr-search/trial/2015-003073-15/results (added 17/06/2020)
Publication list