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Gelofusine® vs Geloplasma® in major abdominal surgery

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN27267911
Enrollment
30
Registered
2008-07-29
Start date
2009-02-04
Completion date
Unknown
Last updated
2019-05-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Volume expansion during major abdominal surgery Surgery Other complications of surgical and medical care, not elsewhere classified

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

Sponsors

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

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: 1. Known hypersensitivity to Gelofusine® or Geloplasma® 2. Oliguric or anuric renal dysfunction requiring dialysis 3. Estimated glomerular filtration rate (EGFR) 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

Design outcomes

Primary

MeasureTime frame
The following will be monitored during the surgery and two hours in recovery: 1. Postoperative chloride level 2. Postoperative base excess

Secondary

MeasureTime frame
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

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026