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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 operation

Augmented Renal Clearance in patients undergoing cancer surgery and its impact on pharmacokinetics of administered antibiotics.

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2018/03/012596
Enrollment
86
Registered
2018-03-15
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Cancer patients undergoing surgeries which will last for more than 3hrs

Interventions

Intervention1: Nil: Nil Control Intervention1: Nil: Nil

Sponsors

Tata Memorial Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
To establish if ARC is observed in patients undergoing major surgeryTimepoint: 1.12 hrs prior surgery 2. just prior initiation of surgery 3. at time of wound closure after surgery—

Secondary

MeasureTime frame
To study the association of inflammatory biomarker levels with the development of ARC.Timepoint: 1. one day prior the surgery 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—

Countries

India

Contacts

Public ContactDr Sheila Nainan Myatra

Tata Memorial Center

sheila150@hotmail.com9820156070

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026