Plain English Summary
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 October 2019
Who is funding the study?
National Natural Science Foundation of China (China)
Who is the main contact?
Prof. Yi Liu (Scientific)
Prof Yi Liu
The department of anesthesiology
Changhai Hospital of Shanghai
NO.168 Changhai road
The effectiveness of methylprednisone to pevent urosepsis after percutaneous nephrolithotomy in patients with high risk
It is hypothesised that methylprednisone would decrease the incidence of urosepsis after percutaneous nephrolithotomy in patients with high risk
Shanghai Changhai Hospital Ethics Committee - approval pending
Perspective randomized single-blind placebo-controlled study
Primary study design
Secondary study design
Randomised controlled trial
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Urosepsis after percutaneous nephrolithotomy
After induction of general anesthesia, participants are divided into two groups according to the method of random number table. In the group M, the participants are given methylprednisone 40mg intravenously before the operation. In the group C, the participants are given an equal volume of normal saline.
All participants are followed up until they are discharged.
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 trial start date
Overall trial end date
Reason abandoned (if study stopped)
Participant 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
Target number of participants
100 cases, 50 cases in each group
Participant 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
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
Changhai Hospital of Shanghai
NO.168 Changhai Road
National Natural Science Foundation of China
National Science Foundation of China, Natural Science Foundation of China, NSFC
Funding Body Type
Funding Body Subtype
Results and Publications
Publication and dissemination plan
Planned publication in a high impact peer-reviewed journal.
IPD sharing statement:
The datasets generated during and/or analysed during the current study are/will be available upon request using the contact details above.
Intention to publish date
Participant level data
Available on request
Basic results (scientific)