Renoprotection with hydration
| ISRCTN | ISRCTN10684639 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10684639 |
- Submission date
- 10/10/2023
- Registration date
- 06/11/2023
- Last edited
- 06/11/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Plain English summary of protocol
Background and study aims
The aim of this study is to determine the effect of giving intravenous saline (0.9%) hydration before open heart surgery on kidney function after surgery and the prevention of acute kidney injury.
Who can participate?
Patients aged 18 to 85 years with normal kidney function who are undergoing cardiac surgery
What does the study involve?
Participants are randomly allocated to one of two groups. The first group (control group) will have fluid restriction for 12 hours before surgery and the second group (case group) will be hydrated with 0.9% normal saline for 12 hours before surgery.
What are the possible benefits and risks of participating?
This study aims to prevent kidney injury with a basic low-cost technique. The researchers monitor the participants to prevent hypervolemia (fluid overload) so are no risks expected.
Where is the study run from?
Kartal Koşuyolu High Specialization Training and Research Hospital (Turkey)
When is the study starting and how long is it expected to run for?
June 2020 to December 2021
Who is funding the study?
Kartal Koşuyolu High Specialization Training and Research Hospital (Turkey)
Who is the main contact?
Mrs Ayse Zehra Karakoc, aysezehra.karakoc@saglik.gov.tr (Turkey)
Contact information
Public, Scientific, Principal Investigator
Department of Cardiovascular Surgery
Kırıkkale High Specialization Hospital
Baglarbası Avenue
Ahmet Ay st.
Kirikkale
71450
Türkiye
 ORCID ID |
0000-0003-0345-7666 |
|---|---|
| Phone | +90 (0)5353927076 |
| aysezehra.karakoc@saglik.gov.tr |
Public
Department of Cardiovascular Surgery
Kırıkkale High Specialization Hospital
Baglarbası Avenue
Ahmet Ay st.
Kirikkale
71450
Türkiye
| Phone | +90 (0)5353927076 |
|---|---|
| aysezehrakarakoc@gmail.com |
Study information
| Study design | Prospective randomized controlled study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | The effect of preoperative hydration on cardiac surgery-associated acute kidney injury |
| Study objectives | The hypothesis of this study is that preoperative intravenous saline (0.9%) hydration can prevent postoperative cardiac surgery-associated acute kidney injury instead of the traditional dehydration protocols prior to surgery |
| Ethics approval(s) |
Approved 22/09/2020, Health Sciences University Kartal Kosuyolu High Specialization Training and Research Hospital’s Clinical Research Ethics Committee (Denizer st. Cevizli Avenue, Istanbul, 34865, Türkiye; +90 (0)2165001500; aysezehrakarakoc@gmail.com), ref: 2020/8/36122/09/2020 |
| Health condition(s) or problem(s) studied | Open-heart surgery in patients with a glomerular filtration rate (GFR) >45 ml/min/1.73 m², not undergoing dialysis, and without ventricular dysfunction |
| Intervention | G-power analysis was used to determine the total sample size and with an effect size of 0.48 (alpha error probability=0.05) and a power value of 0.80, the total required sample size was found to be 110 (at least 55 patients for each group). SPSS v.23 software package was used for data analysis. Patients scheduled for open-heart surgery between October 2020 and December 2020 at Kosuyolu Heart Hospital, with a GFR >45 ml/min/1.73 m2, not undergoing dialysis, and without ventricular dysfunction, were randomly divided into two groups. The first group was left with fluid restriction overnight before surgery, while the second group was subjected to preoperative 12-hour intravenous hydration with 0.9% saline. During this process, their total fluid intake and outputs were monitored to avoid any hypervolemia. |
| Intervention type | Other |
| Primary outcome measure | BUN, creatinine, and GFR values and blood gas values (pH, lactate, HCO3, Na++, K+, etc.) measured on postoperative days 0, 1, 2, 3, and 7, and at the first month and the first year |
| Secondary outcome measures | 1. Total drainage recorded during the hospital stays of the patients 2. ICU stay recorded during the hospital stays of the patients 3. Total hospital stay recorded during the hospital stays of the patients 4. Extubation times recorded during the hospital stays of the patients |
| Overall study start date | 01/06/2020 |
| Completion date | 31/12/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 85 Years |
| Sex | Both |
| Target number of participants | 110 |
| Total final enrolment | 110 |
| Key inclusion criteria | 1. Undergoing an open heart surgery procedure with cardiopulmonary bypass 2. GFR >45 ml/min/1.73 m² 3. Not undergoing dialysis 4. Normal left and right ventricular functions |
| Key exclusion criteria | Patients undergoing emergency surgery, aortic dissection and complex aortic surgery patients, congenital heart surgery patients, minimal invasive and redo patients |
| Date of first enrolment | 01/10/2020 |
| Date of final enrolment | 31/12/2020 |
Locations
Countries of recruitment
- Türkiye
Study participating centre
Istanbul
34865
Türkiye
Sponsor information
Hospital/treatment centre
Denizer st Cevizli Avenue Kartal
Istanbul
34846
Türkiye
| Phone | +90 (0)2165001500 |
|---|---|
| kosuyolu@saglik.gov.tr | |
| Website | kosuyolu@saglik.gov.tr |
"ROR" |
https://ror.org/054q9np86 |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 11/11/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | While the entire dataset is not publicly accessible to protect individuals' privacy, a subset of the data (excluding patients' names and IDs) will be shared on reasonable request to Ayse Zehra Karakoc (aysezehra.karakoc@saglik.gov.tr) |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | 03/11/2023 | No | No |
Additional files
Editorial Notes
17/10/2023: Study's existence confirmed by the Health Sciences University Kartal Kosuyolu High Specialization Training and Research Hospital’s Clinical Research Ethics Committee (Turkey).
