Status:
COMPLETED
Responses to Colloid Infusions
Lead Sponsor:
University of Nottingham
Collaborating Sponsors:
Sherwood Forest Hospitals NHS Foundation Trust
Conditions:
Laparoscopic Cholecystectomy
Eligibility:
All Genders
18-60 years
Phase:
PHASE3
Brief Summary
In situations such as dehydration, illness and surgery, fluid 'drips' are given to patients to keep them hydrated. Different fluids stay in the circulation for different lengths of time. For example, ...
Detailed Description
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 ex...
Eligibility Criteria
Inclusion
- Male and female patients aged 18-60 years undergoing elective laparoscopic cholecystectomy for proven gallstone disease.
- BMI of 20-26 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
- (Females of child bearing age will be offered a pregnancy test)
Exclusion
- 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
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2011
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00868062
Start Date
April 1 2009
End Date
November 1 2011
Last Update
November 16 2011
Active Locations (1)
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1
Sherwood Forest Hospitals NHS Foundation Trust
Mansfield, Nottinghamshire, United Kingdom, NG17 4JL