comparison of two different methods of fluid management on function of kidney in patients undergoing surgery for kidney stones

Not yet recruiting

Conditions: Calculus of kidney and ureter,

Registration Number: CTRI/2018/12/016693

Lead Sponsor: University College of Medical Sciences and GTB Hospital

Brief Summary: Aim of present study is to evaluate postoperative acute kidney injury in patients undergoing PCNL surgery, following intraoperative use of conventional versus stroke volume variation directed fluid therapy. The primary objective will be to evaluate incidence of early postoperative acute kidney injury as defined by the KDIGO criteria. The secondary objectives are to evaluate severity of acute kidney injury, change in serum creatinine and change in estimated GFR. This will be a prospective, randomised,blinded pilot study which includes adult patients of age between 16 and 65 years scheduled for PCNL surgery under general anaesthesia.The study population will be divided in to 2 goups, 30 patients in each and intraoperative fluid administration carried out accordingly. For stroke volume variation directed fluid therapy, fluid boluses will be used whenever the variation is >10% in supine or >14% in prone position; in conventional group we will use the formula of Holiday and Segar for estimating fluid volumes. We will be following up patients for incidence of early postoperative acute kidney injury upto 48 hours postoperatively as well as severity of acute kidney injury , changes in serum creatinine and eGFR. Intergroup comparison for qualitive data will be done using chi-square or Fischerâ€™s exact test, for non- normally distributed quantitative data using Mann-Whitney U test, and for normally distributed quantitative data using unpaired t-test.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 40

Inclusion Criteria

Those patients who are scheduled for pcnl (percutaneous nephrolithotomy) surgery under general anaesthesia.

Exclusion Criteria

patients <16 years and >65 years Those receiving renal replacement therapy or with transplanted kidney or clinical evidence of significant dysrhythmia, cardiac failure,stroke, coronary heart disease.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of early postoperative AKI as defined by the KDIGO criteria (i.e., serum creatinine with/without urine output)	Preoperative, 24 hours and 48 hours postoperatively.

Secondary Outcome Measures

Name	Time	Method
change in estimated GFR which will be calculated using MDRD equation.	difference between serum creatinine values preoperatively as well as 24 hours and 48 hours postoperatively.
change in serum creatinine values	difference between serum creatinine values preoperatively and postoperatively at 24 hours and 48 hours
severity of AKI as defined by KDIGO criteria	estimation of serum creatinine values preoperatively as well as 24 hours and 48 hours postoperatively

Trial Locations

Locations (1): University College of Medical Sciences and GTB Hospital
🇮🇳
East, DELHI, India
University College of Medical Sciences and GTB Hospital
🇮🇳East, DELHI, India
Dr Asha Tyagi
Principal investigator
9818606404
drashatyagi@gmail.com