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

NCT02789579 | Unknown Early Phase 1

• 1 other identifier: XH-16-010
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Complication of Surgical Procedure

Keywords

prophylactic; Urinary Tract Infections; Minimally invasive upper tract lithotomy

Outcome Measures

Primary Outcomes (1)

• 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.

  3 or 7 days after operation

Secondary Outcomes (1)

• Evidence of clinically urosepsis confirmed by laboratory examination, urine bacterial culture, and vital signs

  3 or 7 days after operation

Study Arms (5)

levofloxacin 3 days group

EXPERIMENTAL

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; Drug: cefuroxime

nitrofurantoin 3 days group

EXPERIMENTAL

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; Drug: cefuroxime

cefuroxime group

EXPERIMENTAL

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

levofloxacin 7 days group

EXPERIMENTAL

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; Drug: cefuroxime

nitrofurantoin 7 days group

EXPERIMENTAL

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; Drug: cefuroxime

Interventions

levofloxacin DRUG

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.

Also known as: Cravit

levofloxacin 3 days group; levofloxacin 7 days group

Nitrofurantoin DRUG

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.

Also known as: Furadantin

nitrofurantoin 3 days group; nitrofurantoin 7 days group

cefuroxime DRUG

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.

Also known as: zinacef

cefuroxime group; levofloxacin 3 days group; levofloxacin 7 days group; nitrofurantoin 3 days group; nitrofurantoin 7 days group

Eligibility Criteria

• Age: 16 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Xinhua Hospital, Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

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

Shanghai, Shanghai Municipality, 200092, China

RECRUITING

Related Publications (2)

• 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.

  PMID: 17313438 RESULT

• 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.

  PMID: 20570319 RESULT

MeSH Terms

Conditions

Urinary Tract Infections

Interventions

Levofloxacin; Nitrofurantoin; Cefuroxime

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Ofloxacin; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nitrofurans; Nitro Compounds; Organic Chemicals; Furans; Heterocyclic Compounds, 1-Ring; Cephalosporins; beta-Lactams; Lactams; Amides; Thiazines; Sulfur Compounds

Study Officials

• li lixia, Master

  Xinhua Hospital, Shanghai Jiaotong University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Li lixia, Master

CONTACT

(86)021-25078999; llxlyy88@sina.com

Li liaxia

CONTACT

(86)021-25078999; llxlyy88@sina.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2016
• First Posted: June 3, 2016
• Study Start: September 1, 2016
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: October 1, 2019

Record last verified: 2019-09

Locations

CN (1)