Gelofusine® vs Geloplasma® in major abdominal surgery

ISRCTN	ISRCTN27267911
DOI	https://doi.org/10.1186/ISRCTN27267911
EudraCT/CTIS number	2008-005175-10
Secondary identifying numbers	N/A

Submission date: 11/07/2008
Registration date: 29/07/2008
Last edited: 17/04/2019

Recruitment status: Stopped
Overall study status: Stopped
Condition category: Surgery

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English Summary

Not provided at time of registration

Contact information

Dr Stephen Tricklebank
Scientific

Guy's and St Thomas' Hospital NHS Foundation Trust
Anaesthetic Department
St Thomas' Hospital
Westminster Bridge Road
London
SE1 7EH
United Kingdom

Phone	+44 20 7188 8768
Email	stephen.tricklebank@gstt.nhs.uk

Study information

Study design	Prospective, randomised, double-blind study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Volume expansion using a balanced gelatin solution in patients undergoing major abdominal surgery
Study hypothesis	Null hypothesis: There is no difference in postoperative chloride levels between patients resuscitated with a balanced gelatin solution or a conventional non-balanced gelatin solution.
Ethics approval(s)	Awaiting approval by the Guy's and St Thomas' Research Ethics Committee as of 15/07/2008.
Condition	Volume expansion during major abdominal surgery
Intervention	Patients will be managed perioperatively according to the enhanced recovery protocol, which is well established and constitutes routine practice for all patients undergoing major abdominal surgery at St Thomas' Hospital. Monitoring will be standard plus oesophageal Doppler in all cases. An arterial line will be sited in all patients, usually following induction of anaesthesia. A central venous line will be sited as clinically indicated, usually following induction of anaesthesia. A thoracic epidural will be sited at a level appropriate to the site of surgery. Anaesthesia will be induced as deemed appropriate by the anaesthetist, and maintained with volatile or propofol. Epidural or remifentanil infusions will be used as deemed appropriate by the anaesthetist. This does not deviate from standard practice in our centre. Colloid will be used intraoperatively to optimise stroke volume, as guided by parameters obtained by oesophageal Doppler. Patients randomised to the balanced gelatin group will receive Geloplasma® (Fresenius) to optimise stroke volume. Patients randomised to the non-balanced group will receive Gelofusine® (B. Braun Medical Ltd) to optimise stroke volume. In both groups the colloid will be given as a discrete 250 ml bolus, and the change in stroke volume observed. If stroke volume shows a >=10% rise, the bolus will be repeated until no further rise (>=10%) is observed. No further bolus will be given unless stroke volume falls. Vasoconstrictors will be given if hypotension persists after optimisation of stroke volume. Inotropes will be considered if peak velocity is low and the clinical picture is suggestive of poor ventricular function. In both groups, additional crystalloid solution will be given to replace insensible loss, or as a solvent for drugs. Blood and clotting products will be given as deemed appropriate by the anaesthetist. Patient temperature will be closely monitored and maintained using a fluid warmer and hot air blanket in all cases. The appropriate colloid will be given in recovery as volume expander as deemed appropriate by the anaesthetist. Arterial blood samples will be obtained from the arterial cannula after induction of anaesthesia (immediately after insertion, before any colloid is given), at the end of surgery before cessation of controlled ventilation, on arrival in recovery, and after 2 hours in recovery. Presence of postoperative nausea and vomiting (and requirement for rescue antiemetics) will be recorded. Volume of colloid given during surgery will be recorded. Urinary sodium will be measured on insertion of the urinary catheter and after 2 hours in recovery. Total duration of treatment and follow-up will be for the duration of the operation and for 2 hours in recovery.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Gelofusine®, Geloplasma®
Primary outcome measure	The following will be monitored during the surgery and two hours in recovery: 1. Postoperative chloride level 2. Postoperative base excess
Secondary outcome measures	The following will be recorded for the duration of surgery, and two hours in recovery: 1. Postoperative pH 2. Volume of colloid given 3. Postoperative renal function 4. Postoperative nausea and vomiting 5. Urinary Sodium 6. Urine output
Overall study start date	04/02/2009
Overall study end date	04/05/2009
Reason abandoned (if study stopped)	Lack of funding/sponsorship

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	30
Participant inclusion criteria	1. Both males and females 2. 18 years or over 3. Patients undergoing major abdominal surgery in the Enhanced Recovery After Surgery programme at Guy's and St Thomas' NHS Foundation Trust, UK 4. American Society of Anaesthesiologists (ASA) grade 1-3
Participant exclusion criteria	1. Known hypersensitivity to Gelofusine® or Geloplasma® 2. Oliguric or anuric renal dysfunction requiring dialysis 3. Estimated glomerular filtration rate (EGFR) <60 ml/min 4. Myocardial infarction within the previous 3 weeks 5. Heart failure (>New York Hearth Association [NYHA] class 2) 6. Liver insufficiency (aspartate aminotransferase >40 U/L, alanine aminotransferase >40 U/L) 7. Absence of written, informed consent
Recruitment start date	04/02/2009
Recruitment end date	04/05/2009

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Guy's and St Thomas' Hospital NHS Foundation Trust

London
SE1 7EH
United Kingdom

Sponsor information

Guy's and St Thomas' NHS Foundation Trust (UK)
Hospital/treatment centre

R&D Department
3rd Floor Conybeare House
Great Maze Pond
London
SE1 9RT
England
United Kingdom

Phone	+44 20 7188 5736
Email	Karen.Ignatian@gstt.nhs.uk
Website	http://www.guysandstthomas.nhs.uk
"ROR"	https://ror.org/00j161312

Funders

Funder type

Hospital/treatment centre

Guy's and St Thomas' NHS Foundation Trust, Department of Anaesthesia (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Editorial Notes

17/04/2019: The EudraCT number has been added.
09/05/2016: This study never took place due to insufficient funding, and has been marked as stopped.
06/05/2016: No publications found, verifying study status with principal investigator.