Solutions comparison as kidney function protectors in patients undergoing a partial laparoscopic nephrectomy

Conditions: partial laparoscopic nephrectomy
MedDRA version: 15.0Level: LLTClassification code 10047691Term: Volume depletionSystem Organ Class: 10027433 - Metabolism and nutrition disorders
MedDRA version: 15.0Level: LLTClassification code 10034072Term: Partial nephrectomySystem Organ Class: 10042613 - Surgical and medical procedures
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

Registration Number: EUCTR2012-003398-24-ES

Lead Sponsor: FUNDACIÓ PUIGVERT

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

Patients older than 18;
Patients undergoing a partial laparoscopic nephrectomy;
Preoperative ASA ? III`
Preoperative and intraoperative anaesthesia according to clinical practice
Surgical procedure without complications
Previous informed consent of patients
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 56

Exclusion Criteria

Pregnancy or Breastfeeding
Obesity or overweight, BMI >= 20% regarding ideal
GF < 60ml/min
Severe coronary desease (NYHA class. III and IV)
Allergy to drugs used during anaesthesia

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Assess wether there are differences in the glomerular filtration rate 6 months after laparoscopic partial nephrectomy according administered fluid therapy;Secondary Objective: study wether there are differences among 3 arms in:<br>diuresis during the first postoperative 24 hours;<br>central venous pressure during the first postoperative 24 hours;<br>intraocular pressure during surgical procedure;<br>Blood pressure changes during surgical procedure and in the postoperative period;<br>Postoperative nausea and vomiting incidence;<br>bleeding during surgical procedure and in the postoperative period;<br>possible complications.;Primary end point(s): Glomerular filtration rate at 6 months;Timepoint(s) of evaluation of this end point: 6 months

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): diuresis during first 24 hours<br>central venous pressure during first 24 hours<br>intraocular pressure<br>blood pressure changes<br>nausea and vomiting<br>Bleeding<br>Complications;Timepoint(s) of evaluation of this end point: During the procedure, postoperative period and at 6 months