A study to detect the effect of operation related stress on urine filtration by kidneys in patient undergoing surgery for cancer and effect of increase in urine filtration on blood level of antibiotic drugs given during operatio
- Conditions
- Health Condition 1: null- Cancer patients undergoing surgeries which will last for more than 3hrs
- Registration Number
- CTRI/2018/03/012596
- Lead Sponsor
- Tata Memorial Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1)Adult patients more than 18 years of age.
2)Patients admitted a day prior to surgery.
3)Surgeries lasting more than 3 hours.
4)Surgeries with routine intra-operative placement of arterial line.
5)Normal pre-operative renal functions (Creatinine clearance greater than 90 ml per min per 1.73 meter square)
Exclusion Criteria
1)Emergency Surgery.
2)Patient having pre-operative features suggestive of Systemic Inflammatory Response Syndrome (SIRS) / Sepsis.
2a.Temperature more than 38 degree Celsius (100.4 F) or less than 36 degree Celsius (96.6 F)
2b.Heart Rate more than 90 beats/minute
2c.WBC counts more than 12,000 per uL or less than 4000 per ul or more than 10% immature forms
2d.Respiratory rate more than 20 breaths per minute or paCO2 less than 32mmHg
3)Patients receiving pre-operative antibiotics.
4)Patients with calculated GFR less than 90 ml per min per 1.73 meter square
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To establish if ARC is observed in patients undergoing major surgeryTimepoint: 1.12 hrs prior surgery <br/ ><br>2. just prior initiation of surgery <br/ ><br>3. at time of wound closure after surgery
- Secondary Outcome Measures
Name Time Method To study the association of inflammatory biomarker levels with the development of ARC.Timepoint: 1. one day prior the surgery <br/ ><br>2. at the time of wound closure after surgery;To study the effect of ARC on pharmacokinetics of administered antibiotics.Timepoint: After surgery 5 mins, 15 mins, 30 mins, 1 hr, 1.5 hrs, 2 hrs , 4 hrs, 6 hrs, 8 hrs and 12 hrs