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Completed

NCT Number: NCT01515397

Comparison of Two Gelatine Solutions

The aim of volume replacement is to compensate a reduction in the intravascular volume e.g. during surgery and to counteract hypovolemia in order to maintain hemodynamics and vital functions. To achieve this, different plasma substitutes are available: Albumin, dextran, hydroxyethylstarches and gelatine. The aim of this study is to demonstrate that acid-base alterations during elective abdominal surgery can be reduced by the use of a new gelatine solution.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Universitätsklinikum Aachen, Klinik für Anästhesiologie, Aachen, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion:

  • Male or female patients >= 18 years of age and <= 90 years of age. Women of child bearing potential must test negative on standard pregnancy test.
  • Patients scheduled to undergo elective abdominal surgery (e.g. Rectal resection, liver resection, open bowl resection, duodenopancreatectomy reconstitution).
  • Scheduled intraoperative volume requirement of at least 15 ml / kg body weight (BROCA) gelatine solution
  • Provision of voluntary consent to participate in the study, following a full explanation of the nature and purpose of the study, by signing the informed consent form approved by the Institutional Ethics Committee (IEC) prior to all evaluations.

Exclusion:

  • Patients of ASA-class > III
  • Known hypersensitivity to gelatine or to any of the constituents of the solution
  • Patients treated with other colloid solutions and / or blood products 24 hours prior to surgery
  • Patients on hemodialysis
  • Patients suffering from decompensated renal function (i.e. serum creatinine > 3.0 mg/dl)
  • Patients suffering from Hypervolemia Hyperhydration Severe blood coagulation disorders Hypernatremia (serum(Na+) > 150 mmol/L) Hyperchloremia (serum(Cl-) > 110 mmol/L)
  • Estimated perioperative need for blood products of 3,5 ml / kg body weight (BROCA)
  • Lactation period
  • Simultaneous participation in another clinical trial
  • Emergencies

Treatment and study plan

Gelofusine balanced

Drug

Gelofusine balanced combined with Sterofundin ISO

Gelofusine 4%

Drug

Gelofusine 4% combined with NaCl 0.9%

Primary outcomes

  1. base excess [mmol/l]

    Time frame: Change from baseline at end of surgery, an expected average of 2 hours surgery

  2. chloride [mmol/l]

    Time frame: Change from baseline at end of surgery, an expected average of 2 hours surgery

Secondary outcomes

  1. arterial blood gase analyses

    Time frame: until 12 hours after surgery

  2. coagulation status

    Time frame: until 12 hours after surgery

  3. renal function

    Time frame: until 12 hours after surgery

  4. adverse events

    Time frame: until 12 hours after surgery

  5. hemodynamics (systolic and diastolic blood pressure)

    Time frame: until 12 hours after surgery

  6. time on ventilation

    Time frame: until 12 hours after surgery

Sponsors and collaborators

Lead sponsor

B. Braun Melsungen AG

Industry

Registry information

Official study title

Efficacy and Safety of a Balanced Gelatine Solution in Combination With a Balanced Electrolyte Solution Versus a Standard Gelatine Solution in Combination With a Non-balanced Electrolyte Solution in Patients Scheduled for Abdominal Surgery

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Jan 24, 2012
Registry last updated
Nov 27, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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