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Completed

NCT Number: NCT00868062

Responses to Colloid Infusions

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.

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Key information

Conditions

Laparoscopic Cholecystectomy

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Sherwood Forest Hospitals NHS Foundation Trust

Mansfield, Nottinghamshire, NG17 4JL, United Kingdom

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Succinylated gelatine, 40g/L, (Gelofusine - B Braun)

Other

1 litre infusion following induction of anaesthesia

Primary outcomes

  1. The magnitude and duration of the plasma volume expanding effects of the two colloids.

    Time frame: 4 hours

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Nottingham

Other

Collaborators

  • Sherwood Forest Hospitals NHS Foundation Trust

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Mar 24, 2009
Registry last updated
Nov 16, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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