To investigate if administration of methylprednisone before surgery could decrease the incidence of urosepsis postoperative in patients with high risks undergoing percutaneous nephrolithotomy
| ISRCTN | ISRCTN16524336 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16524336 |
| Secondary identifying numbers | 01 |
- Submission date
- 02/05/2018
- Registration date
- 21/05/2018
- Last edited
- 10/10/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English summary of protocol
Background and study aims
Percutaneous nephrolithotomy is a surgical procedure to remove kidney stones. Infective complications after this surgery are very common. Among them the spread of a urinary tract infection to the blood stream (urosepsis) is the most severe and sometimes it can lead to the death of patients. In patients with history of unitary tract infection, toxins produced by bacteria (bacteriotoxins) such as endotoxin are absorbed into the circulation during the operation. These toxins can induce great and complex inflammatory response. The patients may undergo high fever, increased heart rate (tachycardia), fast breathing, increased numbers of white blood cells (leukocytosis) and signs of organ injury. These signs are known as urosepsis. It might be effective to prevent urosepsis to inhibit this excessive immune response and inflammation. Methylprednisone is a drug that has been used in clinic widely to reduce the immune system reaction and decrease inflammation.
This study aims to evaluate how well methylprednisone works in preventing urosepsis.
Who can participate?
Adults aged over 17 years undergoing percutaneous nephrolithotomy
What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group receive the drug methylprednisone through a tube in their vein, before the operation. Those in the second group receive a dummy (placebo) substance called saline before the operation. After surgery, participants are followed up until they are discharged from the hospital.
What are the possible benefits and risks of participating?
There is no immediate direct benefit to those taking part. But there should be benefits to future patients because the results of the study are likely to influence the guideline to prevent urosepsis around the time of an operation.
The possible risks of methylprednisone administered are water-sodium retention, electrolyte (chemicals forming electrically charged particles in the body, such as sodium) disturbances and accumulation of fluid in tissues within the body (edema). In consideration of the low dose used in this study, the harmful response of methylprednisone might be little if any. What is more, the investigators care for the participants intensively throughout the period of operation and manage any harmful response in time.
Where is the study run from?
Changhai Hospital of Shanghai (China)
When is the study starting and how long is it expected to run for?
May 2018 to March 2020
Who is funding the study?
National Natural Science Foundation of China (China)
Who is the main contact?
Prof. Yi Liu (Scientific)
ziboliuyi@yeah.net
Contact information
Scientific
The department of anesthesiology
Changhai Hospital of Shanghai
NO.168 Changhai road
Shanghai
200433
China
 ORCID ID |
0000-0002-1804-3602 |
|---|
Study information
| Study design | Perspective randomized single-blind placebo-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 below to request a patient information sheet |
| Scientific title | The effectiveness of methylprednisone to pevent urosepsis after percutaneous nephrolithotomy in patients with high risk |
| Study objectives | It is hypothesised that methylprednisone would decrease the incidence of urosepsis after percutaneous nephrolithotomy in patients with high risk |
| Ethics approval(s) | Shanghai Changhai Hospital Ethics Committee, 17/05/2018, CHEC2018-060 |
| Health condition(s) or problem(s) studied | Urosepsis after percutaneous nephrolithotomy |
| Intervention | Current interventions as of 24/09/2018: After induction of general anesthesia, participants are allocated to one of two groups using stratified block randomization, with the stratified factor being gender. In group M, the participants are given methylprednisone 40mg intravenously before the operation. In group C, the participants are given an equal volume of normal saline. All participants are followed up until they are discharged. Previous interventions: After induction of general anesthesia, participants are divided into two groups according to the method of random number table. In group M, the participants are given methylprednisone 40mg intravenously before the operation. In group C, the participants are given an equal volume of normal saline. All participants are followed up until they are discharged. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Methylprednisone |
| Primary outcome measure | Incidence of urosepsis is recorded postoperatively by the investigator |
| Secondary outcome measures | Incidence of systemic inflammatory response syndrome (SIRS) and uroseptic shock is recorded postoperatively by the investigator |
| Overall study start date | 01/05/2018 |
| Completion date | 01/03/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 100 cases, 50 cases in each group |
| Total final enrolment | 80 |
| Key inclusion criteria | 1. Scheduled to undergo elective percutaneous nephrolithotomy 2. History of urinary tract infection 3. Once urine culture positive 4. Count of white blood cell in urine ≥ 500/ul 5. Aged over 17 years |
| Key exclusion criteria | 1. Allergic to methylprednisone 2. Use corticosteroids within one month before the operation 3. Use immunodepressant 4. Fasting blood glucose more than 11 mmol/L 5. Active digestive tract ulcer 6. Emergency surgery 7. Pregnant women |
| Date of first enrolment | 01/06/2018 |
| Date of final enrolment | 30/12/2019 |
Locations
Countries of recruitment
- China
Study participating centre
Shanghai
200433
China
Sponsor information
Hospital/treatment centre
NO.168 Changhai Road
Shanghai
200433
China
"ROR" |
https://ror.org/02bjs0p66 |
|---|
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- Chinese National Science Foundation, Natural Science Foundation of China, National Science Foundation of China, NNSF of China, NSF of China, 国家自然科学基金委员会, National Nature Science Foundation of China, Guójiā Zìrán Kēxué Jījīn Wěiyuánhuì, NSFC, NNSF, NNSFC
- Location
- China
Results and Publications
| Intention to publish date | 06/04/2020 |
|---|---|
| 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 | The datasets generated during and/or analysed during the current study are/will be available upon request using the contact details above. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | 06/04/2021 | 06/04/2021 | No | No | |
| Results article | 01/01/2021 | 10/10/2022 | Yes | No |
Additional files
- ISRCTN16524336_BasicResults_06Apr2021.pdf
- Uploaded 06/04/2021
Editorial Notes
10/10/2022: Publication reference added.
06/04/2021: The basic results summary has been uploaded as an additional file.
07/04/2020: The following changes have been made:
1. The intention to publish date has been changed from 01/04/2020 to 06/04/2020.
2. The total final enrolment number has been added.
20/08/2019: The following changes were made to the trial record:
1. The recruitment end date was changed from 01/06/2019 to 30/12/2019.
2. The overall trial end date was changed from 01/10/2019 to 01/03/2020.
3. The intention to publish date was changed from 30/12/2019 to 01/04/2020.
25/09/2018: The recruitment start date has been changed from 20/05/2018 to 01/06/2018.
24/09/2018: The following changes have been made:
1. The ethics approval date and reference number have been added.
2. The interventions have been changed.
