Condition category
Surgery
Date applied
11/07/2008
Date assigned
29/07/2008
Last edited
09/05/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Stephen Tricklebank

ORCID ID

Contact details

Guy's and St Thomas' Hospital NHS Foundation Trust
Anaesthetic Department
St Thomas' Hospital
Westminster Bridge Road
London
SE1 7EH
United Kingdom
+44 20 7188 8768
stephen.tricklebank@gstt.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Volume expansion using a balanced gelatin solution in patients undergoing major abdominal surgery

Acronym

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

Awaiting approval by the Guy's and St Thomas' Research Ethics Committee as of 15/07/2008.

Study design

Prospective, randomised, double-blind study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

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

Phase

Not Specified

Drug names

Gelofusine®, Geloplasma®

Primary outcome measures

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 trial start date

04/02/2009

Overall trial end date

04/05/2009

Reason abandoned

Lack of funding/sponsorship

Eligibility

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 type

Patient

Age group

Adult

Gender

Both

Target number of participants

30

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

United Kingdom

Trial participating centre

Guy's and St Thomas' Hospital NHS Foundation Trust
London
SE1 7EH
United Kingdom

Sponsor information

Organisation

Guy's and St Thomas' NHS Foundation Trust (UK)

Sponsor details

R&D Department
3rd Floor Conybeare House
Great Maze Pond
London
SE1 9RT
United Kingdom
+44 20 7188 5736
Karen.Ignatian@gstt.nhs.uk

Sponsor type

Hospital/treatment centre

Website

http://www.guysandstthomas.nhs.uk

Funders

Funder type

Hospital/treatment centre

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

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.