Clinical Trial Results:
HYDration and bicarbonate to prevent acute Renal injury after endovascular Aneurysm repair: pilot-feasibility randomized controlled study (HYDRA pilot trial)
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Summary
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EudraCT number |
2015-003073-15 |
Trial protocol |
GB |
Global end of trial date |
07 Aug 2017
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Results information
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Results version number |
v1(current) |
This version publication date |
13 Oct 2019
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First version publication date |
13 Oct 2019
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Other versions |
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Summary report(s) |
HYDRA publication |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
0504
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Additional study identifiers
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ISRCTN number |
ISRCTN12291961 | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
University of Leicester
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Sponsor organisation address |
Glenfield Hospital, Leicester, United Kingdom, LE39QP
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Public contact |
Athanasios Saratzis, University of Leicester, 0044 07531418104, as875@le.ac.uk
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Scientific contact |
Athanasios Saratzis, University of Leicester, 0044 07531418104, as875@le.ac.uk
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
29 Sep 2017
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
07 Aug 2017
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Global end of trial reached? |
Yes
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Global end of trial date |
07 Aug 2017
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Was the trial ended prematurely? |
No
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General information about the trial
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Main 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
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Protection of trial subjects |
As per HRA rules for the United Kingdom.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
01 Feb 2016
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
United Kingdom: 58
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Worldwide total number of subjects |
58
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EEA total number of subjects |
58
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
0
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From 65 to 84 years |
58
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85 years and over |
0
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Recruitment
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Recruitment details |
- | |||||||||
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Pre-assignment
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Screening details |
Patients screened weekly at multidisciplinary meeting by the screening nurse. | |||||||||
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Period 1
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Period 1 title |
Main (overall period)
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Is this the baseline period? |
Yes | |||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Not blinded | |||||||||
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Control | |||||||||
Arm description |
- | |||||||||
Arm type |
Active comparator | |||||||||
Investigational medicinal product name |
normal saline
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Dispersion for infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
1ml/kg
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Arm title
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Intervention | |||||||||
Arm description |
- | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
Sodium Bicarbonate
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Concentrate for concentrate for solution for infusion
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Routes of administration |
Intravascular use
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Dosage and administration details |
1ml/kg per patient over 1 hour intravenous infusion as per the study protocol.
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End points reporting groups
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Reporting group title |
Control
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Reporting group description |
- | ||
Reporting group title |
Intervention
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Reporting group description |
- | ||
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End point title |
Recruitment rate | |||||||||
End point description |
Number of individuals agreeing to take part after they have been screened for inclusion in the study. This is ONLY a feasibility trial.
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End point type |
Primary
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End point timeframe |
48 hours
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Statistical analysis title |
Count of individuals taking part | |||||||||
Statistical analysis description |
This is a feasibility trial. For the primary endpoint we only counted the n of individuals taking part.
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Comparison groups |
Control v Intervention
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Number of subjects included in analysis |
58
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Analysis specification |
Pre-specified
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Analysis type |
other | |||||||||
P-value |
= 0 [1] | |||||||||
Method |
Count | |||||||||
Parameter type |
Count of individuals | |||||||||
Confidence interval |
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level |
95% | |||||||||
sides |
2-sided
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lower limit |
- | |||||||||
upper limit |
- | |||||||||
Variability estimate |
Standard deviation
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| Notes [1] - We have not reported a p value as this is a feasibility trial. |
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Adverse events information [1]
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Timeframe for reporting adverse events |
Start of trial until 29th September 2017
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Adverse event reporting additional description |
No adverse events occurred.
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Assessment type |
Systematic | ||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||
Dictionary version |
1.0
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| Frequency threshold for reporting non-serious adverse events: 5% | |||
| Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: This is a small study with 58 participants of a tested medication/product. |
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
