Gelofusine® vs Geloplasma® in major abdominal surgery
| ISRCTN | ISRCTN27267911 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN27267911 |
| Clinical Trials Information System (CTIS) | 2008-005175-10 |
| Protocol serial number | N/A |
| Sponsor | Guy's and St Thomas' NHS Foundation Trust (UK) |
| Funder | Guy's and St Thomas' NHS Foundation Trust, Department of Anaesthesia (UK) |
- 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 of protocol
Not provided at time of registration
Contact information
Dr Stephen Tricklebank
Scientific
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 |
|---|---|
| stephen.tricklebank@gstt.nhs.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Prospective, randomised, double-blind study |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Volume expansion using a balanced gelatin solution in patients undergoing major abdominal surgery |
| Study objectives | 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. |
| Health condition(s) or problem(s) studied | 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 |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Gelofusine®, Geloplasma® |
| Primary outcome measure(s) |
The following will be monitored during the surgery and two hours in recovery: |
| Key secondary outcome measure(s) |
The following will be recorded for the duration of surgery, and two hours in recovery: |
| Completion 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 | All |
| Target sample size at registration | 30 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 04/02/2009 |
| Date of final enrolment | 04/05/2009 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Guy's and St Thomas' Hospital NHS Foundation Trust
London
SE1 7EH
United Kingdom
SE1 7EH
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
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.
