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 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
Trial website
Contact information
Type
Scientific
Primary contact
Prof Yi Liu
ORCID ID
http://orcid.org/0000-0002-1804-3602
Contact details
The department of anesthesiology
Changhai Hospital of Shanghai
NO.168 Changhai road
Shanghai
200433
China
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
01
Study information
Scientific title
The effectiveness of methylprednisone to pevent urosepsis after percutaneous nephrolithotomy in patients with high risk
Acronym
Study hypothesis
It is hypothesised that methylprednisone would decrease the incidence of urosepsis after percutaneous nephrolithotomy in patients with high risk
Ethics approval
Shanghai Changhai Hospital Ethics Committee, 17/05/2018, CHEC2018-060
Study design
Perspective randomized single-blind placebo-controlled study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Prevention
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Applicable
Drug names
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 trial start date
01/05/2018
Overall trial end date
01/03/2020
Reason abandoned (if study stopped)
Eligibility
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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
100 cases, 50 cases in each group
Total final enrolment
80
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
01/06/2018
Recruitment end date
30/12/2019
Locations
Countries of recruitment
China
Trial participating centre
Changhai Hospital of Shanghai
NO.168 Changhai Road
Shanghai
200433
China
Funders
Funder type
Government
Funder name
National Natural Science Foundation of China
Alternative name(s)
Chinese National Science Foundation, Natural Science Foundation of China, National Science Foundation of China, NNSF of China, NSF of China, NSFC, NNSF, NNSFC
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
China
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
06/04/2020
Participant level data
Available on request
Basic results (scientific)
Publication list