Treatment of Calculous Pyonephrosis With 0.5% Iodophors for I-stage PCNL

NCT03805542 | Unknown DMC

• 1 other identifier: Tj-czq8366
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Urolithiasis

Keywords

calculous pyonephrosis; I-stage PCNL; iodophors

Outcome Measures

Primary Outcomes (2)

• 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?

  Day 3

• Incidence of Urosepsis

  Is there a statistical difference in the incidence of urosepsis between the control group and the experimental group?

  Day 3

Study Arms (2)

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

Combination Product: 0.5% Iodophors

Interventions

0.5% Iodophors COMBINATION_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.

I-stage operation group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tongji Hospital: lead

Study Sites (1)

Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

Location

MeSH Terms

Conditions

Urolithiasis

Interventions

Iodophors

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Iodine Compounds; Inorganic Chemicals

Study Officials

• Xinguang Wang, M.A.

  Ph.D. Postgraduates

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhiqiang Chen, M.D.,Ph.D

CONTACT

+86 13995512271; zhqchen8366@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2019
• First Posted: January 15, 2019
• Study Start: August 1, 2019
• Primary Completion: August 1, 2020
• Study Completion: August 1, 2020
• Last Updated: August 7, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)