Responses to Colloid Infusions

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00868062
Recruitment Status : Completed
First Posted : March 24, 2009
Last Update Posted : November 16, 2011
Sherwood Forest Hospitals NHS Foundation Trust
Information provided by (Responsible Party):
University of Nottingham

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, 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.

Condition or disease Intervention/treatment Phase
Laparoscopic Cholecystectomy Other: Succinylated gelatine, 40g/L, (Gelofusine - B Braun) Phase 3

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 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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
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
Study Start Date : April 2009
Actual Primary Completion Date : November 2011
Actual Study Completion Date : November 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Gelatin

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

Primary Outcome Measures :
  1. The magnitude and duration of the plasma volume expanding effects of the two colloids. [ Time Frame: 4 hours ]

Secondary Outcome Measures :
  1. To determine the effects of the two infusions on serum and urinary osmolality, sodium, potassium, chloride, bicarbonate, urea, albumin, microalbumin and haematological parameters. [ Time Frame: 4 hours ]

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00868062

United Kingdom
Sherwood Forest Hospitals NHS Foundation Trust
Mansfield, Nottinghamshire, United Kingdom, NG17 4JL
Sponsors and Collaborators
University of Nottingham
Sherwood Forest Hospitals NHS Foundation Trust
Principal Investigator: Dileep Lobo, FRCS University of Nottingham
Principal Investigator: Mukul Dube, FRCS Sherwood Forrest Hospitals NHS Trust

Responsible Party: University of Nottingham Identifier: NCT00868062     History of Changes
Other Study ID Numbers: 08101 colloidAug08
First Posted: March 24, 2009    Key Record Dates
Last Update Posted: November 16, 2011
Last Verified: November 2011

Keywords provided by University of Nottingham:
The responses of patients to 1L infusions of Gelofusine (succinylated gelatine 40g/L) and Voluven (6% hydroxyethyl starch in 0.9% saline) intraoperatively.

Additional relevant MeSH terms:
Plasma Substitutes
Blood Substitutes