Percutaneous NephrolithotomyNCT04340037
Prediction of Sepsis After Percutaneous Nephrolithotomy
An observational study of Percutaneous Nephrolithotomy and Infection, run by Tongji Hospital at 1 site in China.
Trial summary
We aim to determine the preoperative predictors of sepsis after percutaneous nephrolithotomy (PCNL) in patients with unilateral, solitary and proximal ureteral stones. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Percutaneous Nephrolithotomy, Infection, Urolithiasis
- What is being tested?
- percutaneous nephrolithotomy
- Type of treatment
- Surgery or procedure
- How many people
- 745 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2019to 20 Feb 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A total of 745 patients who underwent PCNL from January 2012 to December 2018 were enrolled when meeting eligibility criteria
Who may be able to join
- (1) PCNL was performed to treat unilateral, solitary, and proximal ureteral stones; and (2) age ≥18 years
Who cannot join
- anatomical renal abnormalities (horseshoe kidney, solitary kidney, transplant kidney and kidney duplication)
Trial locations and contacts
1 site in 1 country.
China1 site
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030
About this study
Official title: A Pre-operative Nomogram for Sepsis After Percutaneous Nephrolithotomy Treating Solitary, Unilateral, and Proximal Ureteral Stones
We aim to determine the preoperative predictors of sepsis after percutaneous nephrolithotomy (PCNL) in patients with unilateral, solitary and proximal ureteral stones.
- Being tested
- percutaneous nephrolithotomy
- Medical subject headings
- Infections, Urolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
percutaneous nephrolithotomyProcedure or surgery
percutaneous surgery using nephroscope
| Study group | Role | What they receive |
|---|---|---|
| proximal ureteral stone patient | Patients underwent percutaneous nephrolithotomy treating unilateral, solitary and proximal ureteral stones. Receives: Procedure: percutaneous nephrolithotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
sepsis
the concurrence of infection and a minimum of two of the following within 48 hours of surgery: (1) heart rate >90/minute, (2) body temperature >38°C, (3) leukocyte count <4,000 cells/μL or >12,000 cells/μL, and (4) respiratory rate >20/minute
Measured: within 48 hour after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2020
- Study start1 Mar 2019
- Primary completion1 Jan 2020
- Study completion20 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Percutaneous NephrolithotomyStudies of the same condition, open and under way.
- More trials run by Tongji HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 745 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li Cong, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04340037
- Sponsor's protocol ID
- 2019S1035v2
- Status last verified
- Apr 2020
- First submitted
- 7 Apr 2020
- Last updated
- 9 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data is not suitable to be public
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pre-operative Nomogram for Sepsis After Percutaneous Nephrolithotomy Treating Solitary, Unilateral, and Proximal Ureteral Stones
- ClinicalTrials.gov ID
- NCT04340037
- Acronym / sponsor ID
- 2019S1035v2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 745 participants (actual)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 20 Feb 2020 (actual)
- First posted
- 9 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
We aim to determine the preoperative predictors of sepsis after percutaneous nephrolithotomy (PCNL) in patients with unilateral, solitary and proximal ureteral stones.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| proximal ureteral stone patient | – | Procedure: percutaneous nephrolithotomyPatients underwent percutaneous nephrolithotomy treating unilateral, solitary and proximal ureteral stones. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 745 patients who underwent PCNL from January 2012 to December 2018 were enrolled when meeting eligibility criteria
Key inclusion criteria (1 listed)
- (1) PCNL was performed to treat unilateral, solitary, and proximal ureteral stones; and (2) age ≥18 years
Key exclusion criteria (1 listed)
- anatomical renal abnormalities (horseshoe kidney, solitary kidney, transplant kidney and kidney duplication)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| percutaneous nephrolithotomypercutaneous surgery using nephroscope | Procedure or surgery | proximal ureteral stone patient |
Primary outcome
sepsis
Time frame: within 48 hour after surgery
the concurrence of infection and a minimum of two of the following within 48 hours of surgery: (1) heart rate >90/minute, (2) body temperature >38°C, (3) leukocyte count <4,000 cells/μL or >12,000 cells/μL, and (4) respiratory rate >20/minute
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2020.
- Individual participant dataSharing planned: No. The data is not suitable to be public
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Percutaneous Nephrolithotomy and Infection, run by Tongji Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sepsis (time frame: within 48 hour after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2020.