search
Back to results

The Preventive Infection Role of One Week Antibiotics Before Minimally Invasive Upper Tract Lithotomy

Primary Purpose

Complication of Surgical Procedure

Status
Unknown status
Phase
Early Phase 1
Locations
China
Study Type
Interventional
Intervention
levofloxacin
Nitrofurantoin
cefuroxime
Sponsored by
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Complication of Surgical Procedure focused on measuring prophylactic, Urinary Tract Infections, Minimally invasive upper tract lithotomy

Eligibility Criteria

16 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Clinical diagnosis of urinary tract lithiasis (stones ≥ 2cm) or urolithiasis with hydronephrosis

Exclusion Criteria:

  • antimicrobial drugs been administered in the latest month
  • immunosuppressor been administered in the latest month
  • urinary tract infection or positive urine culture results
  • history of urinary calculi surgery
  • diabetes
  • chronic renal failure patients
  • neurogenic bladder dysfunction
  • abnormal anatomy of the kidney
  • neuromuscular dysfunction (spina bifida, paraplegia, green Barry syndrome, or quadriplegia)
  • more than 90 minutes operation time
  • more than 1000 ml blood loss

Sites / Locations

  • Department of Pharmacy, Xinhua Hospital, Shanghai Jiaotong University School of Medicine.Kongjiang Road 1665,Recruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

levofloxacin 3 days group

nitrofurantoin 3 days group

cefuroxime group

levofloxacin 7 days group

nitrofurantoin 7 days group

Arm Description

There are 30 patients in the group,each patient meets the eligibility criteria and does not meet the exclusion criteria,and receives levofloxacin 0.5g,qd,po 3 days before Minimally invasive upper tract lithotomy.

There are 30 patients in the group,each patient meets the eligibility criteria and does not meet the exclusion criteria,and receives nitrofurantoin 0.1g, tid, po 3 days before Minimally invasive upper tract lithotomy.

There are 150 patients in the group,each patient meets the eligibility criteria and does not meet the exclusion criteria,and does not receive oral antibiotics 7 days before Minimally invasive upper tract lithotomy.All patients in all groups, 30 minutes before surgery, are given preventive medication cefuroxime 1.5g ivgtt, and continue using 1.5g q12h ivgtt until postoperative 48 hours.

There are 30 patients in the group,each patient meets the eligibility criteria and does not meet the exclusion criteria,and receives levofloxacin 0.5g,qd,po 7 days before Minimally invasive upper tract lithotomy.

There are 30 patients in the group,each patient meets the eligibility criteria and does not meet the exclusion criteria,and receives nitrofurantoin 0.1g, tid, po 7 days before Minimally invasive upper tract lithotomy.

Outcomes

Primary Outcome Measures

Evidence of clinically urinary tract infection confirmed by laboratory examination or urine bacterial culture.
Compared with control group, the positive rate of operative blood routine, CRP, urine routine, urine culture, procalcitonin , bacterial endotoxin test of experimental group are declining.

Secondary Outcome Measures

Evidence of clinically urosepsis confirmed by laboratory examination, urine bacterial culture, and vital signs
Compared with control group, the positive rate of operative blood culture, procalcitonin are declining.

Full Information

First Posted
April 15, 2016
Last Updated
September 29, 2019
Sponsor
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
search

1. Study Identification

Unique Protocol Identification Number
NCT02789579
Brief Title
The Preventive Infection Role of One Week Antibiotics Before Minimally Invasive Upper Tract Lithotomy
Official Title
The Preventive Urinary Tract Infection Role of One Week Solutions of Antimicrobial Application Before Minimally Invasive Upper Tract Lithotomy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Unknown status
Study Start Date
September 2016 (Actual)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Minimally invasive upper tract lithotomy is currently a common operation method on treatment of urinary tract stones, but the postoperative complication urinary tract infection or urinary sepsis has turned into a serious threat to the patient's life, when severe, can result in a higher death rate.Although more the more importance were attached to, an effective prevention measures still have not been found. Among Urinary calculi, the higher rates of infection stone resulted in a higher incidence of postoperative urinary tract infection. The conventional postoperative prophylaxis medicine was the use of antimicrobial drugs half an hour before surgery.Foreign studies had shown that continuous preoperative one week use of nitrofurantoin can significantly reduce the incidence of urinary sepsis. So the investigators assume that preoperative extended use time of prophylaxis antibiotic may reduce the incidence of urinary tract infection or urinary sepsis. This study uses a computerized random method. According to preoperative use of different antimicrobial drug or treatment, all patients are randomly divided into five groups, namely levofloxacin 3days group,levofloxacin 7days group, nitrofurantoin 3days group,nitrofurantoin 7days group and cefuroxime group.The levofloxacin group receives levofloxacin 0.5g, qd, po, the nitrofurantoin group was given oral nitrofurantoin 100mg, tid, po.to explore the better antibiotics types, medication timing and duration of treatment to prevent postoperative infection after minimally invasive upper tract lithotomy, so as to reduce the incidence of postoperative urinary tract infection or sepsis.
Detailed Description
Sample Calculation: Based on the literature, the occurrence rate of fever after Percutaneous Nephrolithotripsy (PCNL) was 21% -39.8%, urinary tract infection rate 38%, SIRS rate 11.2%, the incidence rate of urinary sepsis 0.3% - 4.7%,and the mortality rate with sepsis was 60% -80%. Expected incidence rate of urinary tract infection decreased to 23%, and the difference is statistically significant. Provided that the case of the two groups is equal, the expected strength of evidence is 0.9, α = 0.05, the lost up to 20%, the investigators calculated that the minimum sample size required is 150 cases. Urology department has 70 ward beds with PCNL surgery or Flexible Ureteroscopy Lithotripsy (FURL) about 400 cases per year, and the sample size can meet the study requirements. All cases are from outpatient or emergency department. Grouping and medication: This study uses a computerized random method. According to preoperative use of different antimicrobial drug or treatment, all patients are randomly divided into five groups, namely levofloxacin 3days group,levofloxacin 7days group, nitrofurantoin 3days group,nitrofurantoin 7days group and cefuroxime group.and each group of levofloxacin group or nitrofurantoin group has been given prophylactic for 3 or 7 days. The levofloxacin group receives levofloxacin 0.5g, qd, po, the nitrofurantoin group was given oral nitrofurantoin 100mg, tid, po. All patients in cefuroxime group, 30 minutes before surgery, are given preventive medication cefuroxime 1.5g ivgtt, and continue using 1.5g q12h ivgtt until postoperative 48 hours. Sterilization or bacterial culture: Surgical areas is disinfected with 10% povidone-iodine, all surgical instruments are sterilized by high-temperature steam. after renal pelvises are punctured, some urine is extracted for bacterial culture. Stones removed by surgery are fragmented into small fragments, and stored at 36.5 ℃ tubes within a day in order to facilitate the proliferation of bacteria, then grown in culture medium for bacterial culture. Preoperative items observed: urinalysis, urine culture, renal function, blood, CRP, procalcitonin, bacterial endotoxin test, kidney function, body temperature changes prophylactic or preoperative. Imaging tests include urinary tract calculi line pyelography and CT. Postoperative follow-up: urine, urine culture, renal function, blood routine, CRP, procalcitonin, bacterial endotoxin test, renal function and urinary tract stones line urography and CT examination were made in all patients. Vital signs such as body temperature, heart rate and blood pressure once every two hours were monitored in 48 hours, and were monitored every 4 hours after 48 hours. Blood routine was checked daily until 3 days postoperative or 48 hours after abatement of fever. When white blood cell count> 12 × 109 / L and / or body temperature> 38 ℃ °, it is considered to be systemic inflammatory response (SIRS, modified Sepsis Diagnostic Criteria). Renal fistula was retained for 48 hours Postoperative, and pleural effusion fistula was removed if there was no fever after it was pinched 24 hours. Statistical analysis: Statistical Product and Service Solutions (SPSS)19.0 statistical software was used for analysis. Count data were analyzed by analysis of variance or t Test. Measurement data were analyzed by Chi-square Test. The results were evaluated within the safe range of 95%,when P <0.05,it was statistically significant.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Complication of Surgical Procedure
Keywords
prophylactic, Urinary Tract Infections, Minimally invasive upper tract lithotomy

7. Study Design

Primary Purpose
Prevention
Study Phase
Early Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
levofloxacin 3 days group
Arm Type
Experimental
Arm Description
There are 30 patients in the group,each patient meets the eligibility criteria and does not meet the exclusion criteria,and receives levofloxacin 0.5g,qd,po 3 days before Minimally invasive upper tract lithotomy.
Arm Title
nitrofurantoin 3 days group
Arm Type
Experimental
Arm Description
There are 30 patients in the group,each patient meets the eligibility criteria and does not meet the exclusion criteria,and receives nitrofurantoin 0.1g, tid, po 3 days before Minimally invasive upper tract lithotomy.
Arm Title
cefuroxime group
Arm Type
Experimental
Arm Description
There are 150 patients in the group,each patient meets the eligibility criteria and does not meet the exclusion criteria,and does not receive oral antibiotics 7 days before Minimally invasive upper tract lithotomy.All patients in all groups, 30 minutes before surgery, are given preventive medication cefuroxime 1.5g ivgtt, and continue using 1.5g q12h ivgtt until postoperative 48 hours.
Arm Title
levofloxacin 7 days group
Arm Type
Experimental
Arm Description
There are 30 patients in the group,each patient meets the eligibility criteria and does not meet the exclusion criteria,and receives levofloxacin 0.5g,qd,po 7 days before Minimally invasive upper tract lithotomy.
Arm Title
nitrofurantoin 7 days group
Arm Type
Experimental
Arm Description
There are 30 patients in the group,each patient meets the eligibility criteria and does not meet the exclusion criteria,and receives nitrofurantoin 0.1g, tid, po 7 days before Minimally invasive upper tract lithotomy.
Intervention Type
Drug
Intervention Name(s)
levofloxacin
Other Intervention Name(s)
Cravit
Intervention Description
There are 50 patients in the group,each patient receives levofloxacin 0.5g, qd, po 7 days before Minimally invasive upper tract lithotomy.All patients in all groups, 30 minutes before surgery, are given preventive medication cefuroxime 1.5g ivgtt, and continue using 1.5g q12h ivgtt until postoperative 48 hours.
Intervention Type
Drug
Intervention Name(s)
Nitrofurantoin
Other Intervention Name(s)
Furadantin
Intervention Description
There are 50 patients in the group,each patient receives nitrofurantoin 0.1g, qd, po 7 days before Minimally invasive upper tract lithotomy.All patients in all groups, 30 minutes before surgery, are given preventive medication cefuroxime 1.5g ivgtt, and continue using 1.5g q12h ivgtt until postoperative 48 hours.
Intervention Type
Drug
Intervention Name(s)
cefuroxime
Other Intervention Name(s)
zinacef
Intervention Description
There are 150 patients in the group, 30 minutes before surgery, each patient is given preventive medication cefuroxime 1.5g ivgtt, and continue using 1.5g q12h ivgtt until postoperative 48 hours.
Primary Outcome Measure Information:
Title
Evidence of clinically urinary tract infection confirmed by laboratory examination or urine bacterial culture.
Description
Compared with control group, the positive rate of operative blood routine, CRP, urine routine, urine culture, procalcitonin , bacterial endotoxin test of experimental group are declining.
Time Frame
3 or 7 days after operation
Secondary Outcome Measure Information:
Title
Evidence of clinically urosepsis confirmed by laboratory examination, urine bacterial culture, and vital signs
Description
Compared with control group, the positive rate of operative blood culture, procalcitonin are declining.
Time Frame
3 or 7 days after operation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Clinical diagnosis of urinary tract lithiasis (stones ≥ 2cm) or urolithiasis with hydronephrosis Exclusion Criteria: antimicrobial drugs been administered in the latest month immunosuppressor been administered in the latest month urinary tract infection or positive urine culture results history of urinary calculi surgery diabetes chronic renal failure patients neurogenic bladder dysfunction abnormal anatomy of the kidney neuromuscular dysfunction (spina bifida, paraplegia, green Barry syndrome, or quadriplegia) more than 90 minutes operation time more than 1000 ml blood loss
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Li lixia, Master
Phone
(86)021-25078999
Email
llxlyy88@sina.com
First Name & Middle Initial & Last Name or Official Title & Degree
Li liaxia
Phone
(86)021-25078999
Email
llxlyy88@sina.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
li lixia, Master
Organizational Affiliation
Xinhua Hospital, Shanghai Jiaotong University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Pharmacy, Xinhua Hospital, Shanghai Jiaotong University School of Medicine.Kongjiang Road 1665,
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200092
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Li lixia, Master
Email
llxlyy88@sina.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
17313438
Citation
Sofikerim M, Gulmez I, Karacagil M. One week of ciprofloxacin before percutaneous nephrolithotomy significantly reduces upper tract infection and urosepsis: a prospective controlled study. BJU Int. 2007 Feb;99(2):466. doi: 10.1111/j.1464-410X.2007.06746_6.x. No abstract available.
Results Reference
result
PubMed Identifier
20570319
Citation
Bag S, Kumar S, Taneja N, Sharma V, Mandal AK, Singh SK. One week of nitrofurantoin before percutaneous nephrolithotomy significantly reduces upper tract infection and urosepsis: a prospective controlled study. Urology. 2011 Jan;77(1):45-9. doi: 10.1016/j.urology.2010.03.025. Epub 2010 Jun 8.
Results Reference
result

Learn more about this trial

The Preventive Infection Role of One Week Antibiotics Before Minimally Invasive Upper Tract Lithotomy

We'll reach out to this number within 24 hrs