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12 February 2012
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| [ ...Back to search results ] | [ Print-friendly version ] |
| Gelofusine® vs Geloplasma® in major abdominal surgery |
| ISRCTN | ISRCTN27267911 |
| ClinicalTrials.gov identifier | |
| Public title | Gelofusine® vs Geloplasma® in major abdominal surgery |
| Scientific title | Volume expansion using a balanced gelatin solution in patients undergoing major abdominal surgery |
| Acronym | N/A |
| Serial number at source | N/A |
| 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. |
| Lay summary | |
| Ethics approval | Awaiting approval by the Guy's and St Thomas' Research Ethics Committee as of 15/07/2008. |
| Study design | Prospective, randomised, double-blind study |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Volume expansion during major abdominal surgery |
| Participants - 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 |
| Participants - 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 |
| Anticipated start date | 04/02/2009 |
| Anticipated end date | 04/05/2009 |
| Status of trial | Completed |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 30 |
| Interventions |
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. |
| Primary outcome measure(s) |
The following will be monitored during the surgery and two hours in recovery:
1. Postoperative chloride level 2. Postoperative base excess |
| Secondary outcome measure(s) |
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 |
| Sources of funding | Guy's and St Thomas' NHS Foundation Trust, Department of Anaesthesia (UK) |
| Trial website | |
| Publications | |
| Contact name | Dr Stephen Tricklebank |
| Address |
Guy's and St Thomas' Hospital NHS Foundation Trust
Anaesthetic Department St Thomas' Hospital Westminster Bridge Road |
| City/town | London |
| Zip/Postcode | SE1 7EH |
| Country | United Kingdom |
| stephen.tricklebank@gstt.nhs.uk | |
| Sponsor | Guy's and St Thomas' NHS Foundation Trust (UK) |
| Address |
R&D Department
3rd Floor Conybeare House Great Maze Pond |
| City/town | London |
| Zip/Postcode | SE1 9RT |
| Country | United Kingdom |
| Karen.Ignatian@gstt.nhs.uk | |
| Sponsor website: | http://www.guysandstthomas.nhs.uk |
| Date applied | 11/07/2008 |
| Last edited | 29/07/2008 |
| Date ISRCTN assigned | 29/07/2008 |
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| © 2012 ISRCTN unless otherwise stated. | |
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