Effect of hydroxyethyl starch on renal handling of salt and water, blood pressure-regulating hormones, proteins and circulatory system of patients undergoing kidney removal by keyhole surgery

Conditions: Patients undergoing laparoscopic nefrectomy in generel anesthesia
MedDRA version: 14.1Level: LLTClassification code 10037775Term: Radical nephrectomySystem Organ Class: 10042613 - Surgical and medical procedures
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

Registration Number: EUCTR2011-004273-88-DK

Lead Sponsor: Erling Bjerregaard Pedersen, Medicinsk forskningsafsnit, Regionshospitalet Holstebro

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 40

Inclusion Criteria

- Age > 18 years
- Males and females
- Indication for laparoscopic nephrectomy OR
- Indiction for laparoscopic partial removal of the kidney OR
- Indication for laparoscopic glandel stageing

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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Blooddonation within the last month
- Lack of wish to participate
- eGFR< 15ml/min
- pregnancy or breast feeding

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The objective is for elective laparoscopic nephrectomy to measure the effect of hydroxyethyl starch on biomarkers of nephrotoxicity (U-Alb, u- NGAL, u-Kim 1, u-FABP)<br>;Secondary Objective: Secondarily to measure the effect of hydroxyethyl starch on the renal tubular transport of sodium and water (FENa, u-ENaCß, CH2O, u-AQP2, u-NCC, u-NK2CC), vasoactive hormones (PRC, p-Ang-II, p -Aldo, p-ANP, P-GDP, p-AVP, p-Endot) and central hemodynamics (SBP, DBP, heart rate) during elective laparoscopic nephrectomy<br>;Primary end point(s): u- NGA

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): PRC, p-Ang-II, p-Aldo, p-ANP, p-BNP, p-AVP, p-Endot, CH2O, u-AQP2, FENa u- EnaCß, u-Alb, u-Kim 1, u-FABP, u-NCC, u-NK2CC, heart rate, SBP and DBP