Laparoscopic CholecystectomyPhase 3NCT00868062
Responses to Colloid Infusions
A Phase 3 study testing Succinylated gelatine, 40g/L, (Gelofusine - B Braun) in people with Laparoscopic Cholecystectomy, run by University of Nottingham at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Laparoscopic Cholecystectomy
- What is being tested?
- Succinylated gelatine, 40g/L, (Gelofusine - B Braun)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2009to Nov 2011
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Sherwood Forest Hospitals NHS Foundation Trust
Mansfield, Nottinghamshire, NG17 4JL
About this study
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
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.
Read the 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
- Conditions
- Laparoscopic Cholecystectomy
- Being tested
- Succinylated gelatine, 40g/L, (Gelofusine - B Braun)
- Keywords
- The responses of patients to 1L infusions of Gelofusine (succinylated gelatine 40g/L) and Voluven (6% hydroxyethyl starch in 0.9% saline) intraoperatively.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Succinylated gelatine, 40g/L, (Gelofusine - B Braun)Other
1 litre infusion following induction of anaesthesia
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Other: Succinylated gelatine, 40g/L, (Gelofusine - B Braun) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The magnitude and duration of the plasma volume expanding effects of the two colloids.
Measured: 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.
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2009 (estimated)
- Study startApr 2009
- Primary completionNov 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laparoscopic CholecystectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Collaborators
- Sherwood Forest Hospitals NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Dileep Lobo, FRCS, Principal investigator, University of NottinghamMukul Dube, FRCS, Principal investigator, Sherwood Forrest Hospitals NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00868062
- Sponsor's protocol ID
- 08101 colloidAug08
- Status last verified
- Nov 2011
- First submitted
- 23 Mar 2009
- Last updated
- 16 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00868062
- Acronym / sponsor ID
- 08101 colloidAug08
- Conditions
- Laparoscopic Cholecystectomy
- Keywords
- The responses of patients to 1L infusions of Gelofusine (succinylated gelatine 40g/L) and Voluven (6% hydroxyethyl starch in 0.9% saline) intraoperatively.
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Collaborators
- Sherwood Forest Hospitals NHS Foundation Trust
- Study start
- Apr 2009
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 24 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: Succinylated gelatine, 40g/L, (Gelofusine - B Braun) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Succinylated gelatine, 40g/L, (Gelofusine - B Braun)1 litre infusion following induction of anaesthesia | Other | 1 |
Primary outcome
The magnitude and duration of the plasma volume expanding effects of the two colloids.
Time frame: 4 hours
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2011.
Related trials for Laparoscopic Cholecystectomy
Active, not recruiting
Comparison of Intertransverse Process and Erector Spinae Plane Blocks in Acute Postoperative Analgesia Management for Laparoscopic Cholecystectomy Patients
Acut Postoperative Pain, Erector Spinae Plane Block
RecruitingObservational study
Electrosurgical Patterns and Learning Curve in Elective Laparoscopic Cholecystectomy
Cholelithiasis
Not yet recruiting
Binaural Beats and Postoperative Nausea and Vomiting in Laparoscopic Cholecystectomy
Laparoscopic Cholecystectomy
RecruitingPhase 4
Time to Loss of Consciousness With Remimazolam Versus Propofol for Anesthetic Induction in Laparoscopic Cholecystectomy
Intravenous Anesthesia, Cholelithiasis
Not yet recruiting
Subcostal TAP Block Versus Combined Subcostal TAP and Recto-Intercostal Fascial Plane Block for Analgesia After Laparoscopic Cholecystectomy
Laparoscopic Cholecystectomy, Postoperative Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dileep Lobo, FRCS principal investigator
University of Nottingham
Mukul Dube, FRCS principal investigator
Sherwood Forrest Hospitals NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Succinylated gelatine, 40g/L, (Gelofusine - B Braun) in people with Laparoscopic Cholecystectomy, run by University of Nottingham at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The magnitude and duration of the plasma volume expanding effects of the two colloids. (time frame: 4 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2011.