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    Summary
    EudraCT Number:2015-003073-15
    Sponsor's Protocol Code Number:0504
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2019-03-15
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2015-003073-15
    A.3Full title of the trial
    HYDration and bicarbonate to prevent acute Renal injury after endovascular Aneurysm repair: pilot-feasibility randomized controlled study (HYDRA pilot trial)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Preliminary study assessing how renal damage can be prevented in aneurysm surgery
    A.3.2Name or abbreviated title of the trial where available
    HYDRA-P
    A.4.1Sponsor's protocol code number0504
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorResearch Governance, University of Leicester
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity of Leicester
    B.5.2Functional name of contact pointAthanasios Saratzis
    B.5.3 Address:
    B.5.3.1Street AddressRobert Kilpatrick Building
    B.5.3.2Town/ cityLeicester
    B.5.3.3Post codeLE15WW
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+447531418104
    B.5.6E-mailas875@le.ac.uk
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Sodium Bicarbonate EP
    D.2.1.1.2Name of the Marketing Authorisation holderFresenius Kabi Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameSodium Bicarbonate 8.4% w/v solution for infusion
    D.3.2Product code PL 08828/0043
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSodium Bicarbonate
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/V) percent weight/volume
    D.3.10.2Concentration typeequal
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Acute kidney injury post endovascular repair of the abdominal aortic aneurysm.
    E.1.1.1Medical condition in easily understood language
    Acute kidney damage after elective endovascular stent repair (keyhole) of an abdominal aortic aneurysm
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10000051
    E.1.2Term Abdominal aneurysm
    E.1.2System Organ Class 100000004866
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10000054
    E.1.2Term Abdominal aortic aneurysm
    E.1.2System Organ Class 100000004866
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10069339
    E.1.2Term Acute kidney injury
    E.1.2System Organ Class 10038359 - Renal and urinary disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10068736
    E.1.2Term Acute oliguric renal failure
    E.1.2System Organ Class 10038359 - Renal and urinary disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10001041
    E.1.2Term Acute renal failure
    E.1.2System Organ Class 10038359 - Renal and urinary disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10001051
    E.1.2Term Acute renal failure, unspecified
    E.1.2System Organ Class 10038359 - Renal and urinary disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10070787
    E.1.2Term Anuric renal failure
    E.1.2System Organ Class 10038359 - Renal and urinary disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10068736
    E.1.2Term Acute oliguric renal failure
    E.1.2System Organ Class 10038359 - Renal and urinary disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10001041
    E.1.2Term Acute renal failure
    E.1.2System Organ Class 10038359 - Renal and urinary disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10001051
    E.1.2Term Acute renal failure, unspecified
    E.1.2System Organ Class 10038359 - Renal and urinary disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10070787
    E.1.2Term Anuric renal failure
    E.1.2System Organ Class 10038359 - Renal and urinary disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10061657
    E.1.2Term Arterial stent insertion
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The principal research objective is to examine whether giving a certain type of blood-salt (called bicarbonate) through a vein before we perform a type of surgery to fix swellings (called aneurysms) of the abdominal aorta (the main blood vessel in the abdomen) can prevent damage to the kidneys. Kidney damage, or "Acute kidney injury (AKI)" is a common problem after this type of surgery (the medical term of which is EVAR - that stands for "endovascular repair of and abdominal aortic aneurysm"). Our data suggest that almost 1 in 5 patients having this surgery develop kidney damage. It is well established that this kidney damage (or AKI) can impact on death rates, morbidity, and cost. Bicarbonate, which is a blood-salt, may prevent this. Previous studies in similar types of surgery have shown it to be beneficial in terms of preventing kidney damage. However, it has not been adequately assessed in patients undergoing EVAR so far.

    To answer this question we need to perform a large expen
    E.2.2Secondary objectives of the trial
    1) Tolerability of the intervention by the patients
    2) Feasibility in terms of patient-uptake
    3) Mechanistic effects of the intervention by measuring markers of tubular injury at several points in time
    4) Adequacy of the standardised hydration regime in the two arms
    5) Levels of serum bicarbonate during EVAR

    Based on these, a multidisciplinary team of nephrologists, anaesthetists and vascular surgeons will convene following the completion of the pilot-feasibility stage and the definitive RCT design will be finalized.
    E.2.3Trial contains a sub-study No
    E.3Principal 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.
    E.4Principal 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.
    E.5 End points
    E.5.1Primary end point(s)
    Primary endpoint: development of Acute Kidney Injury (AKI) as per current NICE definition (within the space of 48 hours):

    1. Rise in serum creatinine of 26 micromol/l or greater within 48 hours
    OR
    2. 50% or greater rise in serum creatinine within 48 hours
    OR
    3. Fall in urine output to less than 0.5 ml/kg/hour for more than 6 hours
    E.5.1.1Timepoint(s) of evaluation of this end point
    48 hours after the endovascular repair of the abdominal aortic aneurysm.
    E.5.2Secondary end point(s)
    1. Incidence of different stages of AKI as per NICE guidelines

    2. Change at levels of sub-clinical markers of renal injury before, during, and 6 hours, 24 hours, after EVAR

    Urine markers that will be measured: Albumin, B2M, Cystatin-C, NGAL

    3. Level of pH on arterial blood gas analysis pre-, intra- and post- operatively (induction, during the procedure, prior to extubation, after extubation)

    4. Number of patients agreeing to participate compared to the number of patients invited to participate

    5. Feedback received from patients and healthcare professionals (anaesthetists, vascular surgeons, nursing staff) during the pilot-feasibility regarding the components of the study

    6. Number and nature of adverse events due to bicarbonate administration

    7. Central aortic pressure levels immediately before, during and immediately after EVAR

    8. Bio-impedance levels immediately before, during and immediately after EVAR.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Within 48 hours after the endovascular repair of the abdominal aortic aneurysm and at 30 days after the patient's discharge from hospital after EVAR (to assess AEs).
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Standard clincal intravenous solution
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned2
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA1
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS: The trial will be completed (end of pilot study) when the last subject has attended their 30 day follow up outpatients visit.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days28
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days28
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 10
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 0
    F.4.2.2In the whole clinical trial 60
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    The intervention only applies for 60 minutes whilst the patient is having the intravenous bicarbonate infusion. This will not be provided after the completion of the endovascular aneurysm repair. Patients not randomized to receive the infusion cannot have this at a later stage as it cannot prevent kidney injury if not administered contemporaneously.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation CRN East Midlands
    G.4.3.4Network Country United Kingdom
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2015-12-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-02-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-08-07
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