Condition category
Infections and Infestations
Date applied
02/05/2018
Date assigned
21/05/2018
Last edited
25/09/2018
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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)
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

01/10/2019

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

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

01/06/2019

Locations

Countries of recruitment

China

Trial participating centre

Changhai Hospital of Shanghai
NO.168 Changhai Road
Shanghai
200433
China

Sponsor information

Organisation

Changhai Hospital of Shanghai

Sponsor details

NO.168 Changhai Road
Shanghai
200433
China

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

National Natural Science Foundation of China

Alternative name(s)

National Science Foundation of China, Natural Science Foundation of China, NSFC

Funding Body Type

government organisation

Funding Body Subtype

Federal/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

30/12/2019

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

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.