Responses to Colloid Infusions

This study has been completed.
Sponsor:
Collaborator:
Sherwood Forest Hospitals NHS Foundation Trust
Information provided by (Responsible Party):
University of Nottingham
ClinicalTrials.gov Identifier:
NCT00868062
First received: March 23, 2009
Last updated: November 15, 2011
Last verified: November 2011
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by University of Nottingham:

Primary Outcome Measures:
  • The magnitude and duration of the plasma volume expanding effects of the two colloids. [ Time Frame: 4 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: April 2009
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Other: Succinylated gelatine, 40g/L, (Gelofusine - B Braun)
1 litre infusion following induction of anaesthesia

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

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00868062

Locations
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
Investigators
Principal Investigator: Dileep Lobo, FRCS University of Nottingham
Principal Investigator: Mukul Dube, FRCS Sherwood Forrest Hospitals NHS Trust
  More Information

No publications provided

Responsible Party: University of Nottingham
ClinicalTrials.gov Identifier: NCT00868062     History of Changes
Other Study ID Numbers: 08101 colloidAug08
Study First Received: March 23, 2009
Last Updated: November 15, 2011
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

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:
Polygeline
Plasma Substitutes
Blood Substitutes
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 18, 2014