Condition category
Urological and Genital Diseases
Date applied
02/07/2018
Date assigned
30/11/2018
Last edited
30/11/2018
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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

https://www.ukc-mb.si/

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

Publication citations

Additional files

Editorial Notes