Responses to Colloid Infusions

Laparoscopic Cholecystectomy Clinical Trial

Official title:

Do 100 kiloDaltons Matter? A Prospective Randomised Double-blind Study on the Blood Volume Expanding Effects of Two Different Colloids in Patients Undergoing Laparoscopic Cholecystectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00868062
• Other study ID #: 08101 colloidAug08
• Status: Completed
• Phase: Phase 3
• First received: March 23, 2009
• Last updated: November 15, 2011
• Start date: April 2009
• Est. completion date: November 2011

Study information

• Verified date: November 2011
• Source: University of Nottingham
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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, some types of fluid remain in the circulation for a short time which means patients would need to be given more fluid to achieve the desired effects. Giving a lot of fluid to sick patients can in itself cause problems, for example, it can affect the way the bowels work and delay the patient's recovery from illness. In these situations the investigators use specialized fluids called colloids, that are designed to stay in the circulation for longer. This means a smaller amount of fluid needs to be used and less problems are likely to occur. There are two different types of colloids that are commonly used, but the investigators do not know which of them is better. The purpose of this study is to investigate which of the two different colloids (one is called Gelofusin and the other is called Voluven) works better in patients who undergo surgery. Knowing which of the two fluids works best in patients will help us improve the care of surgical patients. The investigators hypothesis is that the fluid that has the larger size of molecules as part of the solution will work better during surgery.

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 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• 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 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Laparoscopic Cholecystectomy

Intervention

Other:
• Succinylated gelatine, 40g/L, (Gelofusine - B Braun)
1 litre infusion following induction of anaesthesia

Locations

Country	Name	City	State
United Kingdom	Sherwood Forest Hospitals NHS Foundation Trust	Mansfield	Nottinghamshire

Sponsors (2)

Lead Sponsor	Collaborator
University of Nottingham	Sherwood Forest Hospitals NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The magnitude and duration of the plasma volume expanding effects of the two colloids.		4 hours	No
Secondary	To determine the effects of the two infusions on serum and urinary osmolality, sodium, potassium, chloride, bicarbonate, urea, albumin, microalbumin and haematological parameters.		4 hours	No