Plain English Summary
Background and study aims
Loss of kidney function after heart surgery is a complex complication with high mortality (death rate). The aim of this study is to find out whether Vitamin C supplementation decreases the loss of kidney function after open heart surgery.
Who can participate?
Adult patients requiring open heart surgery
What does the study involve?
Participants are randomly allocated to either receive vitamin C or not (control group) before surgery, during surgery and for 5 days after surgery. Kidney function is assessed during surgery and for 5 days after surgery.
What are the possible benefits and risks of participating?
Vitamin C could be potentially a potent kidney protective agent, with practically no expected side effects or risks.
Where is the study run from?
1. University Medical Center Maribor (Slovenia)
2. Institute of Cardiovascular Diseases Vojvodina (Serbia)
When is the study starting and how long is it expected to run for?
November 2017 to September 2020
Who is funding the study?
University Medical Center Maribor (Slovenia)
Who is the main contact?
Assoc. Prof. Miha Antonic, MD, PhD
Trial website
Contact information
Type
Public
Primary contact
Dr Anze Djordjevic
ORCID ID
Contact details
Ljubljanska ulica 5
Maribor
2000
Slovenia
+386 (0)40 260 231
anze.djordjevic@ukc-mb.si
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
2017-2020
Study information
Scientific title
Effect of ascorbic acid supplementation on acute kidney injury after open heart surgery
Acronym
Study hypothesis
1. Ascorbic acid supplementation decreases loss of kidney function in all surgeries
2. Ascorbic acid supplementation decreases loss of kidney function in urgent surgeries
3. Ascorbic acid supplementation decreases loss of kidney function in patients with decreased kidney function and are not on renal replacement therapy (RRT)
4. The main mechanism for acute kidney injuries (AKI) after cardiovascular surgeries is via reactive oxygen species (ROS) and their effect on lipid peroxidation
Ethics approval
Slovenian National Ethics Committee, 22/05/2018, ref: 0120-268/2018/4
Study design
Interventional randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Prevention
Patient information sheet
Condition
Acute kidney injury
Intervention
Patients will be randomized according to their day of birth - the ones on even days will be the control group (no supplement) and the ones on odd days will be the test group (supplement).
Ascorbic acid supplementation protocol:
Before surgery (best in the OR, during intubation/central venous catheter placement/arterial line placement): 2 g
During surgery (best immediately before decross-clamping of aorta): 2 g
Postoperative day (POD) 1: 1 g/8 h
POD 2: 1 g/8 h
POD 3: 1 g/8 h
POD 4: 1 g/8 h
POD 5: 1 g/8 h
In total: 19 g
The trialists will observe two levels in this study: clinical and molecular. In Maribor alone, gas chromatography and mass spectrometry will be used to determine malondyaldehide concentration in the serum of a subgroup of operated patients. Malondyaldehide has been shown as a relevant measuring tool for ROS involvement in lipid peroxidation. It is assumed that it is following a linear model: the more the malondyaldehide in serum, the more ROS in the body. Approximately 100 patient (a subgroup of all included patients) will be divided into two subgroups (depending on ascorbic acid supplementation), their serum samples will be collected intraoperatively, and once a day five days postoperatively to determine malondyaldehide concentration as a function of time.
On the other hand, the trialists will examine the clinical level in all enrolled 400 patients at both institutions (Maribor and Sremska Kamenica). Through creatinine and urea levels, glomerular filtration rate and diuresis, kidney function will be assessed, starting intraoperatively and once a day five days postoperatively.
Intervention type
Supplement
Phase
Drug names
Primary outcome measure
Kidney function assessed using creatinine and urea levels, glomerular filtration rate and diuresis, starting intraoperatively and once a day five days postoperatively
Secondary outcome measures
ROS involvement in lipid peroxidation, assessed using malondyaldehide concentration in serum measured using gas chromatography and mass spectrometry, starting intraoperatively and once a day five days postoperatively
Overall trial start date
01/11/2017
Overall trial end date
30/09/2020
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
All adult patients requiring open heart surgical procedures, regardless of the urgency (urgent vs elective) or type of procedure (coronary revascularization, valvular surgery or aortic surgery)
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
400
Participant exclusion criteria
1. Chronic kidney failure on renal replacement therapy
2. Hyperoxalouria
3. History of kidney stones
Recruitment start date
01/12/2018
Recruitment end date
31/05/2019
Locations
Countries of recruitment
Serbia, Slovenia
Trial participating centre
University Medical Center Maribor
Ljubljanska ulica 5
Maribor
2000
Slovenia
Trial participating centre
Institute of Cardiovascular Diseases Vojvodina
Put dr. Goldmana 4
Sremska Kamenica
21204
Serbia
Sponsor information
Organisation
University Medical Center Maribor
Sponsor details
Ljubljanska ulica 5
Maribor
2000
Slovenia
+386 (0)2 321 1000
javnosti@ukc-mb.si
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
University/education
Funder name
University Medical Center Maribor
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
This study is part of a PhD thesis.
IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from Assoc. Prof. Miha Antonic, MD, PhD (miha.antonic@guest.arnes.si). The data will become available after statistical analysis and public publishment via peer-reviewed article(s). It will be available for all types of analyses.
Intention to publish date
01/12/2019
Participant level data
Available on request
Basic results (scientific)
Publication list