UrolithiasisNCT03805542
Treatment of Calculous Pyonephrosis With 0.5% Iodophors for I-stage PCNL
A study testing 0.5% Iodophors in people with Urolithiasis, run by Tongji Hospital at 1 site in China.
Trial summary
Calculous Pyonephrosis is a special type of urinary tract calculi, which is also common in clinical practice. If pyonephrosis is not treated in time, it will have a serious impact on the kidney function. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Urolithiasis
- What is being tested?
- 0.5% Iodophors
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 1 siteChina
- Study dates
- Aug 2019to Aug 2020
- Phase
- Interventional
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age (>18) at the time of admission;
- Glomerular filtration rate (GFR) > 30 ml/min
- Upper urinary tract calculi with ipsilateral pyogenic infection of renal collecting system
- No fear of cold and fever or low temperature(<36°C) before operation;
- According to the medical principle, PCNL treatment indications were given.
- Leukocyte count was (4-12) 10^9/l. (Note: The above conditions should be met at the same time.)
Who cannot join
- Complicated with severe cardiopulmonary and cerebrovascular diseases, coagulation dysfunction, hypertension, diabetes, etc.
- iodine allergy;
- lonely kidney or transplanted kidney;
- Pregnancy patients;
- those with hyperthyroidism, hypothyroidism or abnormal thyroid function;
- Other matters that are taboo for operation.
Trial locations and contacts
1 site in 1 country.
China1 site
Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030
About this study
Official title: Instillation of Renal Pelvis With 0.5% Iodophors for Patients With Calculous Pyonephrosis for I-stage PCNL : a Multicentre, Prospective, Open, Randomized Clinical Trial
Calculous Pyonephrosis is a special type of urinary tract calculi, which is also common in clinical practice. If pyonephrosis is not treated in time, it will have a serious impact on the kidney function. Most stone operations can be performed in one stage, but there is still some controversy about whether PCNL can be performed in first stage for calculous pyonephrosis. The traditional idea is that nephrostomy should be performed first to induce pyuria caused by influenza, and then stone removal should be done in the second stage. However, I-stage nephrostomy and drainage and II-stage lithotripsy can also lead to prolonged hospitalization, increased medical costs and increased family burden. Based on the current treatment status of pyonephrosis patients, previous animal experimental results and volunteers' blood iodine absorption status, we intend to design a clinical trial of Stage-I percutaneous nephrolithotomy(PCNL) after iodophor disinfection of renal collecting system.
Iodophor, also known as povidone iodine, is composed of iodine and polyol ether surfactants. Iodophor disinfectant is a disinfectant with iodine as its main ingredient. It has strong bactericidal power and broad antimicrobial spectrum. It can kill viruses, bacterial propagules, fungi, protozoa, etc. 0.5% iodophor disinfectant (containing effective iodine 5000mg/L) can form a very thin bactericidal film on the wound surface and release it slowly and persistently.
At present, clinical studies on calculous pyonephrosis at home and abroad are mostly single-center, small sample studies, and lack of randomized controlled clinical trials. In view of the current situation and animal experimental results, we intend to carry out a clinical trial of "iodophor treatment of pyonephrosis and one-stage operation" in order to benefit patients with calculous pyonephrosis.
Read the detailed description
Calculous Pyonephrosis is a special type of urinary tract calculi, which is also common in clinical practice. If pyonephrosis is not treated in time, it will have a serious impact on the kidney function. It can lead to renal failure and atrophy in the late stage. It can also cause acute peritonitis due to pus penetrating the renal capsule and endanger life. Most stone operations can be performed in first stage, but there is still some controversy about whether PCNL can be performed in first stage for calculous pyonephrosis. The traditional idea is that nephrostomy should be performed first to induce pyuria caused by influenza, and then stone removal should be done in the second stage. However, I-stage nephrostomy and drainage and II-stage lithotripsy can also lead to prolonged hospitalization, increased medical costs and increased family burden. With the widespread use of the third and fourth generation lithotripsy machines, ultrasound lithotripsy and lithotripsy system can reduce the pressure in drainage system, which makes more and more urologists begin to try one-stage surgical treatment for calculous pyonephrosis in non-acute infection period. Based on the current treatment status of pyonephrosis patients, previous animal experimental results and volunteers' blood iodine absorption status, we intend to design a clinical trial of Stage-I lithotripsy (PCNL) after iodophor disinfection of renal collecting system.
Iodophor, also known as povidone iodine, is composed of iodine and polyol ether surfactants. Iodophor disinfectant is a disinfectant with iodine as its main ingredient. It has strong bactericidal power and broad antimicrobial spectrum. It can kill viruses, bacterial propagules, fungi, protozoa, etc. 0.5% iodophor disinfectant (containing effective iodine 5000mg/L) can form a very thin bactericidal film on the wound surface and release it slowly and persistently. The principle of sterilization is to denaturate and precipitate proteins in pathogenic organisms, leading to inactivation of bacteria and other microorganisms, so as to achieve the purpose of efficient disinfection and sterilization.
It was found that the pharmacological action of iodophor solution containing 500 mg/L of available iodine was to release iodine gradually, which had the characteristics of low toxicity, little stimulation and long duration of pharmacodynamics. At present, 0.5% iodophor is widely used in skin disinfection before surgery, its effectiveness and safety are confirmed; intravenous drip of antibiotics one hour before surgery and 0.5% iodophor irrigation during operation can significantly reduce the incidence of wound infection after acute appendicitis surgery. In gynecological surgery, 0.5% iodophor is often used to disinfect vaginal mucosa, and effective anti-infective effect is achieved.
It was found that routine iodophor irrigation of wounds for 2-3 minutes during operation could effectively reduce the infection rate after operation, disinfect the skin area of operation field, and the effect of iodophor solution could last until the end of routine operation due to the slow release of iodine ions. Some researchers have studied the toxicology of iodophor disinfectant and found that: (1) the LD50 (Lethal Does,50%)value of animals tested in acute oral toxicity test is more than 5000mg/kg.bw, which is actually non-toxic; (2) multiple skin irritation tests are non-irritating; (3) acute eye irritation tests are non-irritating; (4) rabbit vaginal mucosa irritation index is extremely mild irritation; (5) subacute toxicity tests suggest hematology and there was no statistical difference between the blood biochemical indexes and the control group. Of course, people allergic to iodine preparations are not allowed to use them. At present, there are many reports about the application of iodophor solution in the disinfection of human mucosal tissues. Domestic studies have reported that bladder irrigation with 20 ml 0.5% iodophor in Intensive Care Unit(ICU) can prevent and treat bacterial and fungal infections in urinary tract. Foreign studies have shown that 0.2% povidone iodine can replace 1% silver nitrate for pelvic perfusion in chyluria patients (recurrence rate 9/22, or 22%; average follow-up 23.3 months). It should be noted that vaginal mucosal epithelium is a type of stratified flat epithelium, which belongs to human stratified epithelium. Its surface layer is flat cells with thick epithelium and has mechanical protective effect. The mucosal epithelium of renal pelvis, ureter, bladder and urethra is a kind of transitional epithelium (also known as metastatic epithelium), and also belongs to a kind of stratified epithelium. Its surface layer is columnar cells, because of the shape of these epithelial cells. The shape and hierarchy can change with the contraction or expansion of the organ, so they are named. Transitional epithelium is characterized by dense cytoplasm near the lumen and strong eosinophilic, forming a dark-stained shell, which can prevent the erosion of urine. Therefore, there are some similarities and differences between the two types of epithelium, which is of great significance for us to further study the application of iodophor in transitional epithelium. At present, clinical studies on calculous pyonephrosis at home and abroad are mostly single-center, small sample studies, and lack of randomized controlled clinical trials. In view of the current situation and animal experimental results, we intend to carry out a clinical trial of "iodophor treatment of pyonephrosis and I-stage operation" in order to benefit patients with calculous pyonephrosis.
- Conditions
- Urolithiasis
- Being tested
- 0.5% Iodophors
- Keywords
- calculous pyonephrosis, I-stage PCNL, iodophors
- Medical subject headings
- Urolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.5% IodophorsCombination product
Before lithotripsy, 0.5% iodophor 40 ml(depending on the degree of hydronephrosis) was used to perfuse the calculous side pelvis under low pressure for 5 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | I-stage nephrostomy(Double J stent placement under cystoscopy) and II-stage operation |
| I-stage operation group | Experimental | Disinfection of pelvis with 0.5% iodophors Receives: Combination Product: 0.5% Iodophors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of SIRS(Systemic inflammatory response syndrome)
Is there a statistical difference in the incidence of systemic inflammatory response syndrome between the control group and the experimental group?
Measured: Day 3
Incidence of Urosepsis
Is there a statistical difference in the incidence of urosepsis between the control group and the experimental group?
Measured: Day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2019
- Study startAug 2019 (estimated)
- Primary completionAug 2020 (estimated)
- Study completionAug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UrolithiasisStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 93 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xinguang Wang, M.A., Principal investigator, Ph.D. Postgraduates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03805542
- Sponsor's protocol ID
- Tj-czq8366
- Status last verified
- Jul 2019
- First submitted
- 9 Jan 2019
- Last updated
- 7 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Instillation of Renal Pelvis With 0.5% Iodophors for Patients With Calculous Pyonephrosis for I-stage PCNL : a Multicentre, Prospective, Open, Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03805542
- Acronym / sponsor ID
- Tj-czq8366
- Conditions
- Urolithiasis
- Keywords
- calculous pyonephrosis, I-stage PCNL, iodophors
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 93 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- Aug 2019 (estimated)
- Primary completion
- Aug 2020 (estimated)
- Study completion
- Aug 2020 (estimated)
- First posted
- 15 Jan 2019 (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.
Calculous Pyonephrosis is a special type of urinary tract calculi, which is also common in clinical practice. If pyonephrosis is not treated in time, it will have a serious impact on the kidney function. Most stone operations can be performed in one stage, but there is still some controversy about whether PCNL can be performed in first stage for calculous pyonephrosis. The traditional idea is that nephrostomy should be performed first to induce pyuria caused by influenza, and then stone removal should be done in the second stage. However, I-stage nephrostomy and drainage and II-stage lithotripsy can also lead to prolonged hospitalization, increased medical costs and increased family burden. Based on the current treatment status of pyonephrosis patients, previous animal experimental results and volunteers' blood iodine absorption status, we intend to design a clinical trial of Stage-I percutaneous nephrolithotomy(PCNL) after iodophor disinfection of renal collecting system.
Iodophor, also known as povidone iodine, is composed of iodine and polyol ether surfactants. Iodophor disinfectant is a disinfectant with iodine as its main ingredient. It has strong bactericidal power and broad antimicrobial spectrum. It can kill viruses, bacterial propagules, fungi, protozoa, etc. 0.5% iodophor disinfectant (containing effective iodine 5000mg/L) can form a very thin bactericidal film on the wound surface and release it slowly and persistently.
At present, clinical studies on calculous pyonephrosis at home and abroad are mostly single-center, small sample studies, and lack of randomized controlled clinical trials. In view of the current situation and animal experimental results, we intend to carry out a clinical trial of "iodophor treatment of pyonephrosis and one-stage operation" in order to benefit patients with calculous pyonephrosis.
Detailed description
Calculous Pyonephrosis is a special type of urinary tract calculi, which is also common in clinical practice. If pyonephrosis is not treated in time, it will have a serious impact on the kidney function. It can lead to renal failure and atrophy in the late stage. It can also cause acute peritonitis due to pus penetrating the renal capsule and endanger life. Most stone operations can be performed in first stage, but there is still some controversy about whether PCNL can be performed in first stage for calculous pyonephrosis. The traditional idea is that nephrostomy should be performed first to induce pyuria caused by influenza, and then stone removal should be done in the second stage. However, I-stage nephrostomy and drainage and II-stage lithotripsy can also lead to prolonged hospitalization, increased medical costs and increased family burden. With the widespread use of the third and fourth generation lithotripsy machines, ultrasound lithotripsy and lithotripsy system can reduce the pressure in drainage system, which makes more and more urologists begin to try one-stage surgical treatment for calculous pyonephrosis in non-acute infection period. Based on the current treatment status of pyonephrosis patients, previous animal experimental results and volunteers' blood iodine absorption status, we intend to design a clinical trial of Stage-I lithotripsy (PCNL) after iodophor disinfection of renal collecting system.
Iodophor, also known as povidone iodine, is composed of iodine and polyol ether surfactants. Iodophor disinfectant is a disinfectant with iodine as its main ingredient. It has strong bactericidal power and broad antimicrobial spectrum. It can kill viruses, bacterial propagules, fungi, protozoa, etc. 0.5% iodophor disinfectant (containing effective iodine 5000mg/L) can form a very thin bactericidal film on the wound surface and release it slowly and persistently. The principle of sterilization is to denaturate and precipitate proteins in pathogenic organisms, leading to inactivation of bacteria and other microorganisms, so as to achieve the purpose of efficient disinfection and sterilization.
It was found that the pharmacological action of iodophor solution containing 500 mg/L of available iodine was to release iodine gradually, which had the characteristics of low toxicity, little stimulation and long duration of pharmacodynamics. At present, 0.5% iodophor is widely used in skin disinfection before surgery, its effectiveness and safety are confirmed; intravenous drip of antibiotics one hour before surgery and 0.5% iodophor irrigation during operation can significantly reduce the incidence of wound infection after acute appendicitis surgery. In gynecological surgery, 0.5% iodophor is often used to disinfect vaginal mucosa, and effective anti-infective effect is achieved.
It was found that routine iodophor irrigation of wounds for 2-3 minutes during operation could effectively reduce the infection rate after operation, disinfect the skin area of operation field, and the effect of iodophor solution could last until the end of routine operation due to the slow release of iodine ions. Some researchers have studied the toxicology of iodophor disinfectant and found that: (1) the LD50 (Lethal Does,50%)value of animals tested in acute oral toxicity test is more than 5000mg/kg.bw, which is actually non-toxic; (2) multiple skin irritation tests are non-irritating; (3) acute eye irritation tests are non-irritating; (4) rabbit vaginal mucosa irritation index is extremely mild irritation; (5) subacute toxicity tests suggest hematology and there was no statistical difference between the blood biochemical indexes and the control group. Of course, people allergic to iodine preparations are not allowed to use them. At present, there are many reports about the application of iodophor solution in the disinfection of human mucosal tissues. Domestic studies have reported that bladder irrigation with 20 ml 0.5% iodophor in Intensive Care Unit(ICU) can prevent and treat bacterial and fungal infections in urinary tract. Foreign studies have shown that 0.2% povidone iodine can replace 1% silver nitrate for pelvic perfusion in chyluria patients (recurrence rate 9/22, or 22%; average follow-up 23.3 months). It should be noted that vaginal mucosal epithelium is a type of stratified flat epithelium, which belongs to human stratified epithelium. Its surface layer is flat cells with thick epithelium and has mechanical protective effect. The mucosal epithelium of renal pelvis, ureter, bladder and urethra is a kind of transitional epithelium (also known as metastatic epithelium), and also belongs to a kind of stratified epithelium. Its surface layer is columnar cells, because of the shape of these epithelial cells. The shape and hierarchy can change with the contraction or expansion of the organ, so they are named. Transitional epithelium is characterized by dense cytoplasm near the lumen and strong eosinophilic, forming a dark-stained shell, which can prevent the erosion of urine. Therefore, there are some similarities and differences between the two types of epithelium, which is of great significance for us to further study the application of iodophor in transitional epithelium. At present, clinical studies on calculous pyonephrosis at home and abroad are mostly single-center, small sample studies, and lack of randomized controlled clinical trials. In view of the current situation and animal experimental results, we intend to carry out a clinical trial of "iodophor treatment of pyonephrosis and I-stage operation" in order to benefit patients with calculous pyonephrosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –I-stage nephrostomy(Double J stent placement under cystoscopy) and II-stage operation |
| I-stage operation group | Experimental | Combination Product: 0.5% IodophorsDisinfection of pelvis with 0.5% iodophors |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age (>18) at the time of admission;
- Glomerular filtration rate (GFR) > 30 ml/min
- Upper urinary tract calculi with ipsilateral pyogenic infection of renal collecting system
- No fear of cold and fever or low temperature(<36°C) before operation;
- According to the medical principle, PCNL treatment indications were given.
Key exclusion criteria (6 listed)
- Complicated with severe cardiopulmonary and cerebrovascular diseases, coagulation dysfunction, hypertension, diabetes, etc.
- iodine allergy;
- lonely kidney or transplanted kidney;
- Pregnancy patients;
- those with hyperthyroidism, hypothyroidism or abnormal thyroid function;
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 |
|---|---|---|
| 0.5% IodophorsBefore lithotripsy, 0.5% iodophor 40 ml(depending on the degree of hydronephrosis) was used to perfuse the calculous side pelvis under low pressure for 5 minutes. | Combination product | I-stage operation group |
Primary outcome
Incidence of SIRS(Systemic inflammatory response syndrome)
Time frame: Day 3
Is there a statistical difference in the incidence of systemic inflammatory response syndrome between the control group and the experimental group?
Incidence of Urosepsis
Time frame: Day 3
Is there a statistical difference in the incidence of urosepsis between the control group and the experimental group?
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2019.
- Individual participant dataSharing planned: No
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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.
Xinguang Wang, M.A. principal investigator
Ph.D. Postgraduates
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 0.5% Iodophors in people with Urolithiasis, 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 6 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 7 Aug 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhiqiang Chen, M.D.,Ph.D (+86 13995512271, zhqchen8366@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of SIRS(Systemic inflammatory response syndrome) (time frame: Day 3). The study lists 2 primary outcomes in all. 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 7 Aug 2019.