Patients undergoing laparoscopic cholecystectomy MedDRA version: 9.1 Level: LLT Classification code 10006990 Term: Calculus gallbladder MedDRA version: 9.1 Level: LLT Classification code 10017626 Term: Gallbladder disorder MedDRA version: 9.1 Level: LLT Classification code 10006992 Term: Calculus in gal
Conditions
Interventions
Trade Name: Voluven 6% Solution for infusion
Product Name: Voluven
Pharmaceutical Form: Solution for infusion
CAS Number: 9005270
Other
Sponsors
University of Nottingham
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Male and female patients aged 18-60 years undergoing elective laparoscopic cholecystectomy for proven gallstone disease. • BMI of 20-35 kg/m2 • Able to give voluntary written informed consent to participate in the study • Able to understand the requirements of the study, including anonymous publication, and agree to co-operate with the study procedures 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) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Patients with a known history of allergic reaction to the colloid infusions • Patients with acute cholecystitis or the systemic inflammatory response syndrome • Patients with a serum bilirubin > 25 µmol/l • Females who are pregnant or refuse to have a pregnancy test • Patients with a haemoglobin < 10 g/l • Patients with a history of acute pancreatitis • Patients likely to undergo common bile duct exploration • Patients with renal impairment, ischaemic heart disease, cardiac failure and chronic restrictive airways disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: ; Primary end point(s): The magnitude and duration of the plasma volume expanding effects of the two colloids ;Main Objective: To study the responses of patients to 1 litre infusions of Gelofusine? (succinylated gelatine 40g/L) and Voluven? (6% hydroxyethyl starch in 0.9% saline) over 1 h intraoperatively. In particular, the extent and time course of the effects of the two infusions on haematocrit, serum albumin, serum biochemistry, plasma expanding capacity and the resultant urinary responses will be measured. | — |
Countries
United Kingdom
Outcome results
None listed