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

Phase 1

• Conditions: Intravascular volume deficits in major abdominal surgery; MedDRA version: 9.1Level: PTClassification code 10021137Term: Hypovolaemia

• Registration Number: EUCTR2008-005175-10-GB
• Lead Sponsor: Guys and St Thomas' NHS Foudation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-04-16
• Study Completion: 2011-03-09
• Last Update Posted: 13 October 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 0

Inclusion Criteria

- Patients undergoing major abdominal surgery in the Enhanced Recovery After Surgery programme at Guy’s and St Thomas’ NHS Foundation Trust

- ASA 1-3

- 18 years or over

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Known hypersensitivity to Gelofusine or Geloplasma
- Oliguric or anuric renal dysfunction requiring dialysis
- EGFR < 60 ml/min
- Myocardial infarction within the previous 3 weeks
- Heart failure (>NYHA 2)
- Liver insufficiency (aspartate aminotransferase >40 U litre–1, alanine aminotransferase >40 U litre–1)
- Absence of written, informed consent

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine whether there is any difference in acid-base or electrolyte status between patients resuscitated with a balanced gelatin solution or a conventional unbalanced gelatin solution. ;Secondary Objective: ;Primary end point(s): - Postoperative chloride levels<br>- Postoperative base excess