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Trial record 89 of 10353 for:    Anti-Infective Agents AND Bacterial

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

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ClinicalTrials.gov Identifier: NCT02789579
Recruitment Status : Recruiting
First Posted : June 3, 2016
Last Update Posted : May 11, 2018
Sponsor:
Information provided by (Responsible Party):
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

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.


Condition or disease Intervention/treatment Phase
Complication of Surgical Procedure Drug: levofloxacin Drug: Nitrofurantoin Drug: cefuroxime Early Phase 1

Detailed Description:
  1. 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.
  2. 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.
  3. 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.
  4. 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.
  5. 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.
  6. 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Preventive Urinary Tract Infection Role of One Week Solutions of Antimicrobial Application Before Minimally Invasive Upper Tract Lithotomy
Actual Study Start Date : September 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018


Arm Intervention/treatment
Experimental: levofloxacin 3 days group
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.
Drug: levofloxacin
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.
Other Name: Cravit

Drug: cefuroxime
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.
Other Name: zinacef

Experimental: nitrofurantoin 3 days group
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.
Drug: Nitrofurantoin
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.
Other Name: Furadantin

Drug: cefuroxime
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.
Other Name: zinacef

Experimental: cefuroxime group
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.
Drug: cefuroxime
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.
Other Name: zinacef

Experimental: levofloxacin 7 days group
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.
Drug: levofloxacin
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.
Other Name: Cravit

Drug: cefuroxime
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.
Other Name: zinacef

Experimental: nitrofurantoin 7 days group
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.
Drug: Nitrofurantoin
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.
Other Name: Furadantin

Drug: cefuroxime
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.
Other Name: zinacef




Primary Outcome Measures :
  1. Evidence of clinically urinary tract infection confirmed by laboratory examination or urine bacterial culture. [ Time Frame: 3 or 7 days after operation ]
    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 :
  1. Evidence of clinically urosepsis confirmed by laboratory examination, urine bacterial culture, and vital signs [ Time Frame: 3 or 7 days after operation ]
    Compared with control group, the positive rate of operative blood culture, procalcitonin are declining.



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Ages Eligible for Study:   16 Years to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02789579


Contacts
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Contact: Li lixia, Master (86)021-25078999 llxlyy88@sina.com
Contact: Li liaxia (86)021-25078999 llxlyy88@sina.com

Locations
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China, Shanghai
Department of Pharmacy, Xinhua Hospital, Shanghai Jiaotong University School of Medicine.Kongjiang Road 1665, Recruiting
Shanghai, Shanghai, China, 200092
Contact: Li lixia, Master       llxlyy88@sina.com   
Sponsors and Collaborators
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Investigators
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Principal Investigator: li lixia, Master Xinhua Hospital, Shanghai Jiaotong University School of Medicine

Publications of Results:
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Responsible Party: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT02789579     History of Changes
Other Study ID Numbers: XH-16-010
First Posted: June 3, 2016    Key Record Dates
Last Update Posted: May 11, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine:
prophylactic
Urinary Tract Infections
Minimally invasive upper tract lithotomy

Additional relevant MeSH terms:
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Anti-Infective Agents, Urinary
Anti-Infective Agents
Renal Agents
Anti-Bacterial Agents
Antineoplastic Agents
Infection
Urinary Tract Infections
Urologic Diseases
Levofloxacin
Ofloxacin
Nitrofurantoin
Cefuroxime
Cefuroxime axetil
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors